Trial Outcomes & Findings for Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace (NCT NCT00356057)

NCT ID: NCT00356057

Last Updated: 2018-02-27

Results Overview

Combined, average percentage improvement in 6-minute walk test distance and Minnessota Living With Heart Failure Quality of Life score from baseline to 6-month follow-up for the Protos DR/CLS (Group 1) and Stratos LV (Group 2) compared with the active control (Group 3). The 6-minute walk test is a test that measure how far a patient can walk in 6 minutes in a standardized walking course. Percent Change (0% (worst)-100% (best))

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 153 participants
• Primary outcome timeframe: Change from baseline to six months post-procedure
• Results posted on: 2018-02-27

Participant Flow

A total of 153 patients were enrolled at 22 clinical sites from December 9, 2004 (the first implant of the study) through May 12, 2008.

No patients were excluded before assigment to groups. A total of 27 patients did not receive a device implant due to withdrawal of consent, inelegibility after randomization and unability to implant the LV lead.

Participant milestones

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Overall Study STARTED	58	61	34
Overall Study IMPLANTED	49	52	25
Overall Study COMPLETED	45	47	22
Overall Study NOT COMPLETED	13	14	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace

Baseline characteristics by cohort

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=58 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=61 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=34 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.	Total n=153 Participants Total of all reporting groups
Age, Continuous	74.1 years STANDARD_DEVIATION 8.4 • n=5 Participants	72.7 years STANDARD_DEVIATION 7.8 • n=7 Participants	72.3 years STANDARD_DEVIATION 8.2 • n=5 Participants	73.1 years STANDARD_DEVIATION 8.1 • n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	39 Participants n=7 Participants	17 Participants n=5 Participants	90 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	22 Participants n=7 Participants	17 Participants n=5 Participants	63 Participants n=4 Participants
Region of Enrollment United States	57 participants n=5 Participants	59 participants n=7 Participants	33 participants n=5 Participants	149 participants n=4 Participants
Region of Enrollment Canada	1 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants

PRIMARY outcome

Timeframe: Change from baseline to six months post-procedure

Population: Patients included in this analysis are those patients with complete six minute walk test and Quality of Life data at both baseline and the six-month follow-up.

Combined, average percentage improvement in 6-minute walk test distance and Minnessota Living With Heart Failure Quality of Life score from baseline to 6-month follow-up for the Protos DR/CLS (Group 1) and Stratos LV (Group 2) compared with the active control (Group 3). The 6-minute walk test is a test that measure how far a patient can walk in 6 minutes in a standardized walking course. Percent Change (0% (worst)-100% (best))

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=43 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=43 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=22 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Average Percentage Improvement From Baseline of the 6-minute Walk Test Distance and Minnesota Living With Heart Failure Quality of Life Score at 6-months	40.1 Percent Change Standard Error 5.7	42.5 Percent Change Standard Error 8.9	31.5 Percent Change Standard Error 9.0

PRIMARY outcome

Timeframe: At six months post-procedure

Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications.

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=58 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure	49 Participants	—	—

PRIMARY outcome

Timeframe: At six months post-procedure

Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications. All Stratos systems (in both the biV and RV pacing arms) were evaluated together as pre-specified in the protocol.

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=95 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure	84 Participants	—	—

SECONDARY outcome

Timeframe: Change from baseline to 6 months post-procedure

Population: Subjects with paired baseline and 6-month six-minute walk test data.

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=44 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=44 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=22 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Change in Six-minute Walk Test	48.1 Meters Standard Error 13.2	49.3 Meters Standard Error 12.9	54.5 Meters Standard Error 20.9

SECONDARY outcome

Timeframe: Change from baseline to six months post-procedure

Population: Subjects with paired baseline and 6-month QOL data. A positive score represents improvement from baseline to 6-months.

Quality of Life was evaluated using the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.The questionnaire consists of 21 questions to measure the subjects' perception of how their HF and its treatment affected their ability to live as they wanted during the last month. The questions describe different ways in which some people are affected (i.e. physical, socioeconomic, and psychological impairments). If a question does not apply to a subject or is not related to their HF, then they can answer with a 0. If it does apply to them, then they can rate (from 1 to 5) how much it has affected them. From the 21 questions, the lowest possible total score is 0, and the highest possible total score is 105. A lower score is desirable. This outcome was calculated as QOL score at baseline minus QOL score at 6 months. Therefore, a positive change in QOL score represents an improvement in quality of life, while a negative change in QOL score represents a worsening.

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=43 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=45 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=22 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Change in Quality Of Life (QOL) Score Over 6 Months Calculated as QOL Score at Baseline - QOL Score at 6 Months	28.9 units on a scale Standard Error 3.9	25.2 units on a scale Standard Error 3.2	24.5 units on a scale Standard Error 6.1

SECONDARY outcome

Timeframe: Change from baseline to six months post-procedure

Population: Subjects with paired baseline and 6-month echocardiography data.

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=36 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=42 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=14 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Ejection Fraction	3.1 percent Standard Error 1.3	3.4 percent Standard Error 0.9	-2.6 percent Standard Error 2.6

SECONDARY outcome

Timeframe: Change from baseline to six months post-procedure

Population: Subjects with paired baseline and 6-month NYHA classification data. The outcome of "Improved at least 1 Class" represents a numerically higher NYHA class at baseline than at 6 months (e.g. NYHA class III at baseline changed to NYHA class II at 6 months).

The purpose is to evaluate the change in the participant's NYHA classification.

There are four NYHA classes:

Class I: Patients with cardiac disease, but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Class 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.

Class 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.

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

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=44 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=45 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=22 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Changes in New York Heart Association (NYHA) Classification Improved at least 1 Class	24 Participants	26 Participants	9 Participants
Changes in New York Heart Association (NYHA) Classification No change	17 Participants	17 Participants	11 Participants
Changes in New York Heart Association (NYHA) Classification Worsened at least 1 Class	3 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: At six months post-procedure

Population: Subjects successfully implanted with investigational system.

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=49 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=52 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=25 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Percentage of Patients With Congestive Heart Failure (CHF) Related Hospitalizations	20 percentage of participants analyzed	13 percentage of participants analyzed	16 percentage of participants analyzed

SECONDARY outcome

Timeframe: At six months post-procedure

Population: Subjects enrolled

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=58 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=61 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=34 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Mortality Rate	1.7 percentage of participants analyzed	11.5 percentage of participants analyzed	5.9 percentage of participants analyzed

SECONDARY outcome

Timeframe: Change from baseline to six months post-procedure

Population: Subjects with paired baseline and 6-month echocardiography data.

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=37 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=41 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=18 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Cardiac Remodeling Assessments by Echocardiography - Change in Left Atrial Volume	-3.2 mL Standard Error 2.8	-1.1 mL Standard Error 2.8	13.7 mL Standard Error 6.0

SECONDARY outcome

Timeframe: Change from baseline to six months post-procedure

Population: Subjects with paired baseline and 6-month echocardiography data.

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=41 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=45 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=19 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Mass	-1.2 grams Standard Error 5.7	-14.5 grams Standard Error 8.3	25.1 grams Standard Error 10.5

SECONDARY outcome

Timeframe: Change from baseline to six months post-procedure

Population: Subjects with paired baseline and 6-month echocardiography data.

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=36 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=42 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=15 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Systolic Volume	-7.7 mL Standard Error 1.7	-5.9 mL Standard Error 2.1	8.7 mL Standard Error 4.6

SECONDARY outcome

Timeframe: Change from baseline to six months post-procedure

Population: Subjects with paired baseline and 6-month echocardiography data.

Outcome measures

Measure	biV-pacing With CLS Rate Adaption (Protos CLS) n=36 Participants Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.	biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=42 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.	RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) n=15 Participants Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Diastolic Volume	-10.1 mL Standard Error 3.5	-7.1 mL Standard Error 4.0	9.5 mL Standard Error 8.2

Adverse Events

All Groups

Serious events: 58 serious events

Other events: 102 other events

Deaths: 10 deaths

Serious adverse events

Measure	All Groups n=153 participants at risk
Cardiac disorders Device related	2.6% 4/153 • Number of events 5 • Study duration with a mean enrollment duration of 19.6 months. Adverse events are included for all study groups together.
Cardiac disorders LV lead related	6.5% 10/153 • Number of events 10 • Study duration with a mean enrollment duration of 19.6 months. Adverse events are included for all study groups together.
Cardiac disorders Other medical	29.4% 45/153 • Number of events 65 • Study duration with a mean enrollment duration of 19.6 months. Adverse events are included for all study groups together.
Cardiac disorders Procedure	2.6% 4/153 • Number of events 4 • Study duration with a mean enrollment duration of 19.6 months. Adverse events are included for all study groups together.
Cardiac disorders RV-lead related	5.9% 9/153 • Number of events 11 • Study duration with a mean enrollment duration of 19.6 months. Adverse events are included for all study groups together.

Other adverse events

Measure	All Groups n=153 participants at risk
Cardiac disorders LV lead related	19.6% 30/153 • Number of events 30 • Study duration with a mean enrollment duration of 19.6 months. Adverse events are included for all study groups together.
Cardiac disorders RV lead related	1.3% 2/153 • Number of events 2 • Study duration with a mean enrollment duration of 19.6 months. Adverse events are included for all study groups together.
Cardiac disorders Device related	7.8% 12/153 • Number of events 12 • Study duration with a mean enrollment duration of 19.6 months. Adverse events are included for all study groups together.
Cardiac disorders Procedure	31.4% 48/153 • Number of events 53 • Study duration with a mean enrollment duration of 19.6 months. Adverse events are included for all study groups together.
Cardiac disorders Other medical	35.9% 55/153 • Number of events 90 • Study duration with a mean enrollment duration of 19.6 months. Adverse events are included for all study groups together.

Additional Information

Katerina de Metz, Director Clinical Studies

BIOTRONIK, Inc.

Phone: 5036752169

Email: katerina.demetz@biotronik.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
• Publication restrictions are in place

Restriction type: OTHER