Trial Outcomes & Findings for PreFER Managed Ventricular Pacing (MVP) For Elective Replacement (NCT NCT00293241)

NCT ID: NCT00293241

Last Updated: 2016-06-24

Results Overview

Time to first event of cardiovascular (CV) hospitalization from implant to 2 years post-implant. Hospitalization is defined as: * admission to hospital involving one overnight stay or * emergency room / office visits that result in cardioversions or acute treatment of worsened cardiac condition Cardiovascular is defined as new or worsening: * heart failure (HF), * angina, * myocardial infarction (MI), * any arrhythmia, * stroke, * transient ischemic attack (TIA), * acute peripheral vascular emergencies, * pulmonary embolism.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 630 participants
• Primary outcome timeframe: Implant to 2 years post-implant
• Results posted on: 2016-06-24

Participant Flow

Study start February 2006; last patient enrolled in August 2009.

Patients were electronically randomized. 25 patients were excluded from analysis due to double entry (7) or no evidence of Patient Informed Consent Form (PIC) signed (18).

Participant milestones

Measure	MVP ON Managed Ventricular Pacing programmed on	MVP OFF Managed Ventricular Pacing programmed off: conventional pacing
Overall Study STARTED	299	306
Overall Study COMPLETED	263	265
Overall Study NOT COMPLETED	36	41

Reasons for withdrawal

Measure	MVP ON Managed Ventricular Pacing programmed on	MVP OFF Managed Ventricular Pacing programmed off: conventional pacing
Overall Study Lost to Follow-up	9	16
Overall Study Physician Decision	23	17
Overall Study Withdrawal by Subject	4	8

Baseline Characteristics

PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

Baseline characteristics by cohort

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing	Total n=605 Participants Total of all reporting groups
Age, Continuous	75.1 years STANDARD_DEVIATION 10.9 • n=5 Participants	74.3 years STANDARD_DEVIATION 10.8 • n=7 Participants	74.7 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	125 Participants n=5 Participants	115 Participants n=7 Participants	240 Participants n=5 Participants
Sex: Female, Male Male	174 Participants n=5 Participants	191 Participants n=7 Participants	365 Participants n=5 Participants

PRIMARY outcome

Timeframe: Implant to 2 years post-implant

Population: Patients indicated for Implantable Pulse Generator (IPG) or Implantable Cardioverter Defibrillator (ICD) replacement with a history of right ventricular pacing \> 40%, to be allocated to either Managed Ventricular Pacing (MVP) programming, or conventional dual chamber programming (DDD) without MVP

Time to first event of cardiovascular (CV) hospitalization from implant to 2 years post-implant.

Hospitalization is defined as:

• admission to hospital involving one overnight stay or
• emergency room / office visits that result in cardioversions or acute treatment of worsened cardiac condition

Cardiovascular is defined as new or worsening:

• heart failure (HF),
• angina,
• myocardial infarction (MI),
• any arrhythmia,
• stroke,
• transient ischemic attack (TIA),
• acute peripheral vascular emergencies,
• pulmonary embolism.

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant	43 number of participants	40 number of participants

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Time to first event of death or cardiovascular (CV) hospitalization from implant to 2 years post-implant

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant. Death or CV hospitalization at 1 year	33 participants	30 participants
Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant. Death or CV hospitalization at 2 years	66 participants	57 participants

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Time to first event of atrial tachycardia/ atrial fibrillation (AT/AF) fulfilling one of the following criteria:

• 7 days in a row with device diagnostic showing 20 or more hours in AT/AF or
• a cardioversion was done to terminate AT/AF or
• the patient is during 2 consecutive follow-up (FU) visits in AT/AF

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant Persistent AT/AF at 1 year	27 participants	17 participants
Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant Persistent AT/AF at 2 years	41 participants	30 participants

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Time to development of permanent AF fulfilling one of the following criteria:

• 7 days in a row with device diagnostic showing 20 or more hours in AT/AF and cardioversion failed or
• 7 days in a row with device diagnostic showing 20 or more hours in AT/AF and the investigator decides not to cardiovert the patient

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant Permanent AF at 1 year	8 participants	3 participants
Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant Permanent AF at 2 years	11 participants	8 participants

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Endpoint: Cumulative percentage ventricular pacing documented in the device memory

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Ventricular Pacing Percentage	5 Percentage Ventricular Pacing Interval 1.0 to 41.0	86 Percentage Ventricular Pacing Interval 40.0 to 98.0

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Endpoint: LVEF (%) difference between 2 year post implant and baseline

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time	-1.2 LVEF (%) difference Standard Deviation 10.5	1.4 LVEF (%) difference Standard Deviation 9.5

SECONDARY outcome

Timeframe: Baseline, one year and 2 year post-implant

Endpoint: NYHA classification at Baseline, one year and 2 year post-implant. (Class I is considered a better category and Class IV is considered worse) I Patients with cardiac disease but resulting in no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.

II Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.

III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.

IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort increases.

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Change in New York Heart Association (NYHA) Functional Class No Heart Failure (Baseline)	64 Participants	92 Participants
Change in New York Heart Association (NYHA) Functional Class Class I (Baseline)	99 Participants	87 Participants
Change in New York Heart Association (NYHA) Functional Class Class II (Baseline)	108 Participants	108 Participants
Change in New York Heart Association (NYHA) Functional Class Class III (Baseline)	19 Participants	9 Participants
Change in New York Heart Association (NYHA) Functional Class Class IV (Baseline)	1 Participants	3 Participants
Change in New York Heart Association (NYHA) Functional Class No Heart Failure (12-months)	67 Participants	71 Participants
Change in New York Heart Association (NYHA) Functional Class Class I (12-months)	69 Participants	72 Participants
Change in New York Heart Association (NYHA) Functional Class Class II (12-months)	97 Participants	86 Participants
Change in New York Heart Association (NYHA) Functional Class Class III (12-months)	5 Participants	10 Participants
Change in New York Heart Association (NYHA) Functional Class Class IV (12-months)	0 Participants	2 Participants
Change in New York Heart Association (NYHA) Functional Class No Heart Failure (24-months)	53 Participants	73 Participants
Change in New York Heart Association (NYHA) Functional Class Class I (24-months)	68 Participants	69 Participants
Change in New York Heart Association (NYHA) Functional Class Class II (24-months)	83 Participants	69 Participants
Change in New York Heart Association (NYHA) Functional Class Class III (24-months)	11 Participants	9 Participants
Change in New York Heart Association (NYHA) Functional Class Class IV (24-months)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Endpoint: Use of Anticoagulation at enrollment and every follow-up visit

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Change in Use of Anticoagulation Patients Using Anticoagulants (Baseline)	75 participants	72 participants
Change in Use of Anticoagulation Patients Changing Anticoagulants Use (24-months)	27 participants	33 participants
Change in Use of Anticoagulation Patients with Medication Records (Baseline)	298 participants	304 participants
Change in Use of Anticoagulation Patients with Medication Records (1-month)	271 participants	285 participants
Change in Use of Anticoagulation Patients Changing Anticoagulants Use (1-month)	24 participants	21 participants
Change in Use of Anticoagulation Patients with Medication Records (12-months)	246 participants	257 participants
Change in Use of Anticoagulation Patients Changing Anticoagulants Use (12-months)	28 participants	31 participants
Change in Use of Anticoagulation Patients with Medication Records (24-months)	226 participants	231 participants

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Endpoint: Use of Diuretics, ACE Inhibitors, Beta-Blockers, digitalis, calcium antagonists and antiarrhythmic drugs at enrollment, and 1month, 12 months, and 24 mnths after implant

Outcome measures

Measure	MVP ON n=298 Participants Managed Ventricular Pacing programmed on	MVP OFF n=304 Participants Managed Ventricular Pacing programmed off: conventional pacing
Change in the Use of Cardiovascular Medication Over Time Antiarrhythmic drugs (24-month), n=226, 231	58 participants	76 participants
Change in the Use of Cardiovascular Medication Over Time Beta-blockers (Baseline), n=298, 304	129 participants	116 participants
Change in the Use of Cardiovascular Medication Over Time Digitalis/digoxin (Baseline), n=298, 304	26 participants	30 participants
Change in the Use of Cardiovascular Medication Over Time Calcium antagonists (Baseline), n=298, 304	54 participants	63 participants
Change in the Use of Cardiovascular Medication Over Time Antiarrhythmic drugs (Baseline), n=298, 304	81 participants	103 participants
Change in the Use of Cardiovascular Medication Over Time Beta-blockers (1-month), n=271, 285	117 participants	111 participants
Change in the Use of Cardiovascular Medication Over Time Digitalis/digoxin (1-month), n=271, 285	24 participants	28 participants
Change in the Use of Cardiovascular Medication Over Time Calcium antagonists (1-month), n=271, 285	49 participants	60 participants
Change in the Use of Cardiovascular Medication Over Time Antiarrhythmic drugs (1-month), n=271, 285	75 participants	98 participants
Change in the Use of Cardiovascular Medication Over Time Beta-blockers (12-months), n=246, 257	108 participants	105 participants
Change in the Use of Cardiovascular Medication Over Time Digitalis/digoxin (12-months), n=246, 257	22 participants	26 participants
Change in the Use of Cardiovascular Medication Over Time Calcium antagonists (12-months), n=246, 257	46 participants	52 participants
Change in the Use of Cardiovascular Medication Over Time Antiarrhythmic drugs (12-months), n=246, 257	67 participants	88 participants
Change in the Use of Cardiovascular Medication Over Time Beta-blockers (24-months), n=226, 231	104 participants	93 participants
Change in the Use of Cardiovascular Medication Over Time Digitalis/digoxin (24-months), n=226, 231	20 participants	22 participants
Change in the Use of Cardiovascular Medication Over Time Calcium antagonists (24-months), n=226, 231	36 participants	47 participants

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Endpoint: A high voltage therapy delivered

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Incidence of High Voltage Therapies	1 participants	3 participants

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Time to patient death from any cause

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant All-Cause Death at 1 year	17 participants	7 participants
Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant All-Cause Death at 2 years	31 participants	22 participants

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Endpoint: Stroke

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Stroke Stroke at 1 year	3 participants	4 participants
Stroke Stroke at 2 years	4 participants	6 participants

SECONDARY outcome

Timeframe: Implant to 4 years post-implant

Population: All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.

Endpoint: Number of Cardiovascular hospitalizations per subject

Outcome measures

Measure	MVP ON n=53 Participants Managed Ventricular Pacing programmed on	MVP OFF n=46 Participants Managed Ventricular Pacing programmed off: conventional pacing
Number of Cardiovascular Related Hospitalizations	1.0 Number of CV Hospitalizations Interval 1.0 to 2.0	1.0 Number of CV Hospitalizations Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: Implant to 4 years post-implant

Population: All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.

Endpoint: Duration of Cardiovascular Hospitalizations per subject

Outcome measures

Measure	MVP ON n=53 Participants Managed Ventricular Pacing programmed on	MVP OFF n=46 Participants Managed Ventricular Pacing programmed off: conventional pacing
Duration of Cardiovascular Related Hospitalizations	7.0 Days of CV hospitalizations Interval 4.0 to 12.0	7.5 Days of CV hospitalizations Interval 3.0 to 14.0

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Endpoint: Patient implanted with a replacement ICD developing a class 1 pacemaker indication

Outcome measures

Measure	MVP ON n=28 Participants Managed Ventricular Pacing programmed on	MVP OFF n=21 Participants Managed Ventricular Pacing programmed off: conventional pacing
Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients	0 participants	0 participants

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Endpoint: Change in PR interval, Change in QRS duration and Change in P-wave duration evaluated at enrollment and 24 Month FU

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Change in PR Interval, Change in QRS Duration and Change in P-wave Duration PR interval (ms) difference 24 month-baseline	11.6 milliseconds Standard Deviation 60.9	10.8 milliseconds Standard Deviation 63.6
Change in PR Interval, Change in QRS Duration and Change in P-wave Duration QRS duration (ms) difference: 24 month-baseline	2.6 milliseconds Standard Deviation 32.4	10.8 milliseconds Standard Deviation 41.8
Change in PR Interval, Change in QRS Duration and Change in P-wave Duration P-wave duration (ms) difference: 24 month-baseline	5.2 milliseconds Standard Deviation 41.2	1.1 milliseconds Standard Deviation 38.4

SECONDARY outcome

Timeframe: Implant to 2 years post-implant

Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup

Outcome measures

Measure	MVP ON n=299 Participants Managed Ventricular Pacing programmed on	MVP OFF n=306 Participants Managed Ventricular Pacing programmed off: conventional pacing
Patient Symptoms No symptoms (baseline)	175 participants	193 participants
Patient Symptoms Chest pain (baseline)	24 participants	15 participants
Patient Symptoms Dyspnea (baseline)	65 participants	59 participants
Patient Symptoms Dizziness/presyncope (baseline)	32 participants	27 participants
Patient Symptoms No Symptoms (12 months)	175 participants	184 participants
Patient Symptoms Chest pain (12 months)	11 participants	12 participants
Patient Symptoms Dyspnea (12 months)	36 participants	38 participants
Patient Symptoms Dizziness/presyncope (12 months)	9 participants	17 participants
Patient Symptoms No Symptoms (24 months)	158 participants	160 participants
Patient Symptoms Chest pain (24 months	15 participants	10 participants
Patient Symptoms Dyspnea (24 months)	39 participants	40 participants
Patient Symptoms Dizziness/presyncope (24 months)	8 participants	15 participants

SECONDARY outcome

Timeframe: 2 years post-implant

Endpoint: Cumulative percentage atrial pacing documented in the device memory

Outcome measures

Measure	MVP ON n=279 Participants Managed Ventricular Pacing programmed on	MVP OFF n=283 Participants Managed Ventricular Pacing programmed off: conventional pacing
Atrial Pacing Percentage	68 percentage atrial pacing Interval 36.0 to 94.0	78 percentage atrial pacing Interval 47.0 to 95.0

SECONDARY outcome

Timeframe: 2 years post-implant

Population: Patients with health evaluation completed at 24 months follow-up

Endpoint: Health State evaluation with the EQ-5D questionnaire (range 0-100) . A measure of 100 is better and a measure of 0 is worse.

Outcome measures

Measure	MVP ON n=219 Participants Managed Ventricular Pacing programmed on	MVP OFF n=224 Participants Managed Ventricular Pacing programmed off: conventional pacing
Health State	70.6 units on a Health State scale Standard Deviation 17.2	70.3 units on a Health State scale Standard Deviation 16.6

Adverse Events

MVP ON

Serious events: 85 serious events

Other events: 32 other events

Deaths: 0 deaths

MVP OFF

Serious events: 72 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	MVP ON n=299 participants at risk Managed Ventricular Pacing programmed on	MVP OFF n=306 participants at risk Managed Ventricular Pacing programmed off: conventional pacing
Cardiac disorders First cardiovascular hospitalization within 2 years after implant	14.4% 43/299 • Number of events 43 • Adverse events were collected from baseline until study closure. The following abbreviations are used in the additional description: SAE: serious adverse event. (S)ADE: (serious) adverse device effect. PE: primary endpoint. The following adverse events had to be reported: * SAEs (for study purposes also included: 1) cardioversion and 2) emergency room / office visits resulting in acute treatment for worsened cardiac condition * Deaths * (S)ADE The PE committee adjudicated all reported AEs per the primary objective. No further classification has been done.	13.1% 40/306 • Number of events 40 • Adverse events were collected from baseline until study closure. The following abbreviations are used in the additional description: SAE: serious adverse event. (S)ADE: (serious) adverse device effect. PE: primary endpoint. The following adverse events had to be reported: * SAEs (for study purposes also included: 1) cardioversion and 2) emergency room / office visits resulting in acute treatment for worsened cardiac condition * Deaths * (S)ADE The PE committee adjudicated all reported AEs per the primary objective. No further classification has been done.
Cardiac disorders Cardioversion within 2 years after implant	3.7% 11/299 • Number of events 15 • Adverse events were collected from baseline until study closure. The following abbreviations are used in the additional description: SAE: serious adverse event. (S)ADE: (serious) adverse device effect. PE: primary endpoint. The following adverse events had to be reported: * SAEs (for study purposes also included: 1) cardioversion and 2) emergency room / office visits resulting in acute treatment for worsened cardiac condition * Deaths * (S)ADE The PE committee adjudicated all reported AEs per the primary objective. No further classification has been done.	2.9% 9/306 • Number of events 13 • Adverse events were collected from baseline until study closure. The following abbreviations are used in the additional description: SAE: serious adverse event. (S)ADE: (serious) adverse device effect. PE: primary endpoint. The following adverse events had to be reported: * SAEs (for study purposes also included: 1) cardioversion and 2) emergency room / office visits resulting in acute treatment for worsened cardiac condition * Deaths * (S)ADE The PE committee adjudicated all reported AEs per the primary objective. No further classification has been done.
Nervous system disorders Stroke within 2 years after implant	1.3% 4/299 • Number of events 4 • Adverse events were collected from baseline until study closure. The following abbreviations are used in the additional description: SAE: serious adverse event. (S)ADE: (serious) adverse device effect. PE: primary endpoint. The following adverse events had to be reported: * SAEs (for study purposes also included: 1) cardioversion and 2) emergency room / office visits resulting in acute treatment for worsened cardiac condition * Deaths * (S)ADE The PE committee adjudicated all reported AEs per the primary objective. No further classification has been done.	2.0% 6/306 • Number of events 6 • Adverse events were collected from baseline until study closure. The following abbreviations are used in the additional description: SAE: serious adverse event. (S)ADE: (serious) adverse device effect. PE: primary endpoint. The following adverse events had to be reported: * SAEs (for study purposes also included: 1) cardioversion and 2) emergency room / office visits resulting in acute treatment for worsened cardiac condition * Deaths * (S)ADE The PE committee adjudicated all reported AEs per the primary objective. No further classification has been done.
General disorders Death from any cause within 2 years after implant	10.4% 31/299 • Number of events 31 • Adverse events were collected from baseline until study closure. The following abbreviations are used in the additional description: SAE: serious adverse event. (S)ADE: (serious) adverse device effect. PE: primary endpoint. The following adverse events had to be reported: * SAEs (for study purposes also included: 1) cardioversion and 2) emergency room / office visits resulting in acute treatment for worsened cardiac condition * Deaths * (S)ADE The PE committee adjudicated all reported AEs per the primary objective. No further classification has been done.	7.2% 22/306 • Number of events 22 • Adverse events were collected from baseline until study closure. The following abbreviations are used in the additional description: SAE: serious adverse event. (S)ADE: (serious) adverse device effect. PE: primary endpoint. The following adverse events had to be reported: * SAEs (for study purposes also included: 1) cardioversion and 2) emergency room / office visits resulting in acute treatment for worsened cardiac condition * Deaths * (S)ADE The PE committee adjudicated all reported AEs per the primary objective. No further classification has been done.

Other adverse events

Measure	MVP ON n=299 participants at risk Managed Ventricular Pacing programmed on	MVP OFF n=306 participants at risk Managed Ventricular Pacing programmed off: conventional pacing
General disorders Non serious adverse events up to 2 years follow-up	10.7% 32/299 • Number of events 47 • Adverse events were collected from baseline until study closure. The following abbreviations are used in the additional description: SAE: serious adverse event. (S)ADE: (serious) adverse device effect. PE: primary endpoint. The following adverse events had to be reported: * SAEs (for study purposes also included: 1) cardioversion and 2) emergency room / office visits resulting in acute treatment for worsened cardiac condition * Deaths * (S)ADE The PE committee adjudicated all reported AEs per the primary objective. No further classification has been done.	10.1% 31/306 • Number of events 39 • Adverse events were collected from baseline until study closure. The following abbreviations are used in the additional description: SAE: serious adverse event. (S)ADE: (serious) adverse device effect. PE: primary endpoint. The following adverse events had to be reported: * SAEs (for study purposes also included: 1) cardioversion and 2) emergency room / office visits resulting in acute treatment for worsened cardiac condition * Deaths * (S)ADE The PE committee adjudicated all reported AEs per the primary objective. No further classification has been done.

Additional Information

Lidwien Vainer

Medtronic Bakken

Phone: +31 433566752

Email: lidwien.vainer@medtronic.com

Results disclosure agreements

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

Restriction type: GT60