Trial Outcomes & Findings for ALternate Site Cardiac ReSYNChronization (ALSYNC) Study (NCT NCT01277783)

NCT ID: NCT01277783

Last Updated: 2019-06-20

Results Overview

Adverse events were reviewed by an independent Adverse Event Adjudication Committee. Events classified as complication related to the LV endocardial lead, the investigational delivery system or the implant procedure contribute to the outcome. The percentage of patients free from such complication at 6 months after the procedure was estimated using the Kaplan-Meier method and is reported with the corresponding 95% confidence interval.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 138 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-06-20

Participant Flow

Participant milestones

Measure	LV Endocardial Lead subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing
Overall Study STARTED	138
Overall Study COMPLETED	138
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ALternate Site Cardiac ReSYNChronization (ALSYNC) Study

Baseline characteristics by cohort

Measure	Left Ventricular Endocardial Pacing n=136 Participants All enrolled patients were scheduled to receive a CRT implantation with endocardial LV lead
Age, Customized Age (years)	66 years STANDARD_DEVIATION 10 • n=5 Participants
Sex/Gender, Customized Gender (male)	106 Participants n=5 Participants
New York Heart Association (NYHA) Class NYHA Class I	4 Participants n=5 Participants
New York Heart Association (NYHA) Class NYHA Class II	29 Participants n=5 Participants
New York Heart Association (NYHA) Class NYHA Class III	93 Participants n=5 Participants
New York Heart Association (NYHA) Class NYHA Class IV	10 Participants n=5 Participants
Atrial Fibrillation	68 Participants n=5 Participants
Left Bundle Branch Block (LBBB)	94 Participants n=5 Participants
QRS duration	165 milliseconds (ms) STANDARD_DEVIATION 32 • n=5 Participants
Left Ventricular Ejection Fraction (LVEF)	29 percentage STANDARD_DEVIATION 9 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The Analysis cohort (132) includes the Baseline cohort (136) (Enrolled patients (138), excluding patients exited for eligibility violation without implant attempt and patients removed for major eligibility violation (2)), excluding patients that did not have implant attempt (4).

Adverse events were reviewed by an independent Adverse Event Adjudication Committee. Events classified as complication related to the LV endocardial lead, the investigational delivery system or the implant procedure contribute to the outcome. The percentage of patients free from such complication at 6 months after the procedure was estimated using the Kaplan-Meier method and is reported with the corresponding 95% confidence interval.

Outcome measures

Measure

LV Endocardial Lead n=132 Participants subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing

Percentage of Patients Free From Lead, Delivery System and Implant Related Complications.

82.2 percentage of patients Interval 75.6 to 88.8

SECONDARY outcome

Timeframe: Implant

Population: The Analysis cohort (132) includes the Baseline cohort (136) (Enrolled patients (138), excluding patients exited for eligibility violation without implant attempt and patients removed for major eligibility violation (2)), excluding patients that did not have implant attempt (4).

Number of participants with a successful implant of Model 3830 lead.

Outcome measures

Measure

LV Endocardial Lead n=132 Participants subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing

Implant Success

118 Participants

SECONDARY outcome

Timeframe: Implant

Population: Participants analyzed are those in the Analysis cohort as described before (132). The unit of analysis is a questionnaire for each attempted Model 3820 lead implant (139). In 7 cases their was a repeat procedure (reported as repeat implant attempt or system modification).

Questionaires were collected for each LV lead implant attempt, reattempt, and LV lead modification. To evaluate the ease of positioning of the Model 3830 lead and the Models 6227ATS and 6248HS, JS, JL catheters, a rating scale of Poor, Fair, Good, Very good, and Excellent was used for each of the ten questions on the questionnaire. Outcome reports the number of questionnaires where no single question was answered with Poor.

Outcome measures

Measure

LV Endocardial Lead n=139 questionnaire subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing

Number of Questionnaires Reporting None of the Handling and Implant Characteristics as Poor

75 questionnaire

SECONDARY outcome

Timeframe: 12 months

Population: Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 24 patients had a missing 12-months follow-up visit and 5 had a missing R-wave amplitude measurement

Sensing amplitude measurement was taken with the implanted device at the 12 month follow-up visit.

Outcome measures

Measure

LV Endocardial Lead n=89 Participants subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing

Bipolar Sensing Amplitude of the Model 3830 Lead in the LV at 12 Months

11 Bipolar Sensing Amplitude in milliVolts Standard Deviation 6.4

SECONDARY outcome

Timeframe: 12 months

Population: Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 24 patients had a missing 12-months follow-up visit and 4 had a missing bipolar pacing threshold measurement

Bipolar measurement of Model 3830 lead voltage threshold at 0.4ms pulse width using the implanted device at the 12 month visit

Outcome measures

Measure

LV Endocardial Lead n=90 Participants subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing

Bipolar Pacing Threshold of the Model 3830 Lead in the LV at 12 Months

0.84 Bipolar LV pacing threshold in Volts Standard Deviation 0.27

SECONDARY outcome

Timeframe: 12 months

Population: Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 24 patients had a missing 12-months follow-up visit and 3 had a missing impedance measurement

Measurement of Impedance of the Model 3830 Lead in the LV using the implanted device at the 12 month visit

Outcome measures

Measure

LV Endocardial Lead n=91 Participants subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing

Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 12 Months

596 Bipolar LV Pacing Impedance in Ohms Standard Deviation 80

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 13 patients had a missing 6-months follow-up visit.

NYHA Class change was evaluated between baseline and the 6 months visit. Reported are the subjects with at least 1 class improvement from baseline to 6 months

Outcome measures

Measure

LV Endocardial Lead n=105 Participants subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing

Subjects With 1 Class of NYHA Improvement From Baseline to 6 Months

62 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 24 patients had a missing 12-months follow-up visit, and 18 did not complete the test.

Distance walked at the 6 minute hall walk test at the 12 month visit

Outcome measures

Measure

LV Endocardial Lead n=76 Participants subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing

Distance Walked at 6 Minute Hall Walk at the 12 Month Visit

391 Distance walked in meters Standard Deviation 147

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 18 patients had a missing LVEF measurement at baseline and/or 6 months.

Percent change in Left Ventricular Ejection Fraction (LVEF) was measured from baseline to 6 months

Outcome measures

Measure

LV Endocardial Lead n=100 Participants subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing

Percent Change in Left Ventricular Ejection Fraction From Baseline to 6 Months

36.1 Percent change in LVEF Standard Deviation 12.0

SECONDARY outcome

Timeframe: 6 months

Population: Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 27 patients had a missing LVESV measurement at baseline and/or 6 months.

Milliliters change in Left Ventricular End-Systolic Volume (LVESV) from baseline to 6 months

Outcome measures

Measure

LV Endocardial Lead n=91 Participants subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing

Milliliters Change in Left Ventricular End-Systolic Volume at 6 Months

121 LVESV change in milliliters Standard Deviation 74

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 17 patients had a missing LVEDD measurement at baseline and/or 6 months.

Millimeters change in Left Ventricular End-Diastolic Diameter (LVEDD) from baseline to 6 months

Outcome measures

Measure

LV Endocardial Lead n=101 Participants subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing

Millimeters Change in Left Ventricular End-Diastolic Diameter From Baseline to 6 Months

63.7 millimeters change in LVEDD Standard Deviation 9.9

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 16 patients had a missing MR measurement at baseline and/or 6 months.

Reported is the number of patients with at least one class improvement from baseline to 6 months

Outcome measures

Measure

LV Endocardial Lead n=102 Participants subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing

Number of Subjects With Mitral Regurgitation Improvement of at Least One Class From Baseline to 6 Months

33 Participants

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 22 patients had a missing (NTpro)BNP measurement at baseline and/or 6 months.

Change in either Brain Natriuretic Peptide (BNP) or N-Terminal-prohormone BNP (NT-proBNP) levels from baseline to 6 months

Outcome measures

Measure	LV Endocardial Lead n=86 Participants subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing
Change in (NT-pro)BNP Levels From Baseline to 6 Months BNP	444 change in picograms per milliliter Standard Deviation 587
Change in (NT-pro)BNP Levels From Baseline to 6 Months NT-proBNP	2554 change in picograms per milliliter Standard Deviation 3485

Adverse Events

Left Ventricular Endocardial Pacing

Serious events: 86 serious events

Other events: 49 other events

Deaths: 23 deaths

Serious adverse events

Measure	Left Ventricular Endocardial Pacing n=132 participants at risk subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing
Blood and lymphatic system disorders Anaemia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Angina pectoris	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Angina unstable	2.3% 3/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Atrial fibrillation	3.8% 5/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Atrial flutter	2.3% 3/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Atrial thrombosis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Cardiac arrest	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Cardiac failure	22.7% 30/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Cardiac failure acute	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Cardiac failure chronic	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Cardiac failure congestive	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Cardiac tamponade	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Cardiogenic shock	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Electromechanical dissociation	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Intracardiac thrombus	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Mitral valve incompetence	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Myocardial infarction	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Pericardial effusion	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Ventricular arrhythmia	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Ventricular tachycardia	3.0% 4/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Eye disorders Macular oedema	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Eye disorders Retinal artery thrombosis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Dysphagia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Haematemesis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Melaena	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Rectal haemorrhage	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Retroperitoneal haematoma	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Cardiac failure	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Chest pain	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Implant site haematoma	6.1% 8/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Presyncope	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Pyrexia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Sudden cardiac death	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Systemic inflammatory response syndrome	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Hepatobiliary disorders Cholecystitis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Hepatobiliary disorders Ischaemic hepatitis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Bronchopneumonia	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Device related infection	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Erysipelas	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Implant site infection	2.3% 3/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Infection	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Pilonidal cyst	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Pneumonia	2.3% 3/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Sepsis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Septic shock	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Staphylococcal infection	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Urinary tract infection	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Wound infection	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Cardiac vein perforation	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Clavicle fracture	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Delayed recovery from anaesthesia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Device dislocation	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Device lead damage	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Device migration	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Femur fracture	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Implant site reaction	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Lead dislodgement	4.5% 6/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Wound dehiscence	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Investigations International normalised ratio decreased	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Metabolism and nutrition disorders Hypokalaemia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Musculoskeletal and connective tissue disorders Foot deformity	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Cerebrovascular accident	3.0% 4/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Cognitive disorder	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Neuropathy peripheral	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Syncope	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Transient ischaemic attack	5.3% 7/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Psychiatric disorders Device psychogenic complication	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Renal and urinary disorders Diabetic nephropathy	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Renal and urinary disorders Renal failure	2.3% 3/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Renal and urinary disorders Urinary retention	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary disease	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Cough	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.3% 3/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.3% 3/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Skin and subcutaneous tissue disorders Skin lesion	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Surgical and medical procedures Cardiac failure	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Surgical and medical procedures Extrusion of device	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Surgical and medical procedures Peripheral revascularisation	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Vascular disorders Arterial disorder	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Vascular disorders Deep vein thrombosis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Vascular disorders Haematoma	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Vascular disorders Implant site haematoma	3.0% 4/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.

Other adverse events

Measure	Left Ventricular Endocardial Pacing n=132 participants at risk subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing
Cardiac disorders Angina unstable	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Atrial fibrillation	3.0% 4/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Atrial flutter	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Atrial tachycardia	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Cardiac failure	5.3% 7/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Intracardiac thrombus	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Supraventricular tachycardia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Cardiac disorders Ventricular tachycardia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Ear and labyrinth disorders Vertigo	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Eye disorders Cataract	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Eye disorders Metamorphopsia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Abdominal discomfort	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Abdominal pain upper	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Constipation	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Diarrhoea	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Gastric ulcer	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Gastritis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Oesophageal disorder	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Gastrointestinal disorders Rectal haemorrhage	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Adverse drug reaction	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Asthenia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Chest pain	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Fatigue	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Implant site fibrosis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Implant site haematoma	6.1% 8/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
General disorders Oedema	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Bronchitis	3.8% 5/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Catheter related infection	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Cystitis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Gastroenteritis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Implant site infection	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Influenza	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Localised infection	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Lower respiratory tract infection	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Infections and infestations Urinary tract infection	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Contusion	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Inappropriate device stimulation of tissue	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Inappropriate device therapy	2.3% 3/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Injury, poisoning and procedural complications Lead dislodgement	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Investigations International normalised ratio increased	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Investigations Troponin	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Metabolism and nutrition disorders Gout	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Metabolism and nutrition disorders Hyperkalaemia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Musculoskeletal and connective tissue disorders Arthralgia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Musculoskeletal and connective tissue disorders Limb discomfort	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Musculoskeletal and connective tissue disorders Myalgia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Musculoskeletal and connective tissue disorders Pain in extremity	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Carpal tunnel syndrome	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Convulsion	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Dizziness	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Migraine	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Migraine with aura	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Neuralgia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Parkinson's disease	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Syncope	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Transient ischaemic attack	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Nervous system disorders Vascular dementia	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Psychiatric disorders Confusional state	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Renal and urinary disorders Urinary retention	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.3% 3/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Skin and subcutaneous tissue disorders Blister	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Skin and subcutaneous tissue disorders Erythema	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Skin and subcutaneous tissue disorders Pruritus	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Skin and subcutaneous tissue disorders Rash	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Skin and subcutaneous tissue disorders Skin lesion	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Skin and subcutaneous tissue disorders Transient acantholytic dermatosis	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Vascular disorders Haematoma	2.3% 3/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Vascular disorders Hypotension	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Vascular disorders Implant site haematoma	0.76% 1/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
Vascular disorders Orthostatic hypotension	1.5% 2/132 • Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average. Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.

Additional Information

Mireille van Ginneken, Principal Clinical Research Specialist

Medtronic Bakken Research Center B.V.

Phone: +31433566801

Email: mireille.vanginneken@medronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place