Trial Outcomes & Findings for Predictors of Response to Biventricular Pacing in Heart Failure (NCT NCT00156390)

NCT ID: NCT00156390

Last Updated: 2019-11-06

Results Overview

Quality of Life Questionnaire List of 21 Questions; each question has a Scale 0-5 with 0 = "no" heart failure did not prevent one from living as they want and 5= "yes"heart failure prevented one very much from living as they want. Overall scores between 0-105, with 105 being the worse quality of life.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 187 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2019-11-06

Participant Flow

Participant milestones

Measure	Echo-guided LV Lead Placement echo-guided LV lead placement echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance	LV Lead Placement as Per Standard of Care (Without Echo-guida LV lead placement as per standard of care (without echo-guidance) placement of the LV lead of the biventricular pacing device without echocardiographic guidance
Overall Study STARTED	110	77
Overall Study COMPLETED	96	69
Overall Study NOT COMPLETED	14	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predictors of Response to Biventricular Pacing in Heart Failure

Baseline characteristics by cohort

Measure	Echo-guided LV Lead Placement n=110 Participants echo-guided LV lead placement echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance	LV Lead Placement as Per Standard of Care (Without Echo-guidan n=77 Participants LV lead placement as per standard of care (without echo-guidance) placement of the LV lead of the biventricular pacing device without echocardiographic guidance	Total n=187 Participants Total of all reporting groups
Age, Continuous	66 years n=5 Participants	67 years n=7 Participants	66.5 years n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	17 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	60 Participants n=7 Participants	137 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants	77 participants n=7 Participants	187 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Quality of Life Questionnaire List of 21 Questions; each question has a Scale 0-5 with 0 = "no" heart failure did not prevent one from living as they want and 5= "yes"heart failure prevented one very much from living as they want. Overall scores between 0-105, with 105 being the worse quality of life.

Outcome measures

Measure	Echo-guided LV Lead Placement n=96 Participants echo-guided LV lead placement echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance	LV Lead Placement as Per Standard of Care (Without Echo-guidan n=69 Participants LV lead placement as per standard of care (without echo-guidance) placement of the LV lead of the biventricular pacing device without echocardiographic guidance
Minnesota For Living With Heart Failure Questionnaire	31 units on a scale Standard Deviation 26	24 units on a scale Standard Deviation 20

SECONDARY outcome

Timeframe: 1 year

Population: Echo Results. The numbers in the outcome measure data table represent the patients who had both baseline and follow-up echo data. Patients who died or were lost to follow-up before having their follow-up echocardiogram are not included in this analysis.

These parameters compared the echocardiographic measures at baseline prior to device implantations to those obtained 6 to 12 months after device implantation. Data for ESV and EF are presented as percent relative change (standard deviation)

Outcome measures

Measure	Echo-guided LV Lead Placement n=87 Participants echo-guided LV lead placement echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance	LV Lead Placement as Per Standard of Care (Without Echo-guidan n=62 Participants LV lead placement as per standard of care (without echo-guidance) placement of the LV lead of the biventricular pacing device without echocardiographic guidance
Echocardiographic Changes Relative change in ESV (standard deviation)	-30 percent change Standard Deviation 29	-20 percent change Standard Deviation 25
Echocardiographic Changes Relative change in EF (standard deviation)	12 percent change Standard Deviation 11	9 percent change Standard Deviation 10

Adverse Events

Echo-guided LV Lead Placement

Serious events: 31 serious events

Other events: 8 other events

Deaths: 0 deaths

LV Lead Placement as Per Standard of Care (Without Echo-guidan

Serious events: 36 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Echo-guided LV Lead Placement n=110 participants at risk echo-guided LV lead placement echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance	LV Lead Placement as Per Standard of Care (Without Echo-guidan n=77 participants at risk LV lead placement as per standard of care (without echo-guidance) placement of the LV lead of the biventricular pacing device without echocardiographic guidance
Cardiac disorders Death	13.6% 15/110	19.5% 15/77
Cardiac disorders Heart Failure Hospitalization	14.5% 16/110	27.3% 21/77

Other adverse events

Measure	Echo-guided LV Lead Placement n=110 participants at risk echo-guided LV lead placement echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance	LV Lead Placement as Per Standard of Care (Without Echo-guidan n=77 participants at risk LV lead placement as per standard of care (without echo-guidance) placement of the LV lead of the biventricular pacing device without echocardiographic guidance
Injury, poisoning and procedural complications Device infection	1.8% 2/110 • Number of events 2	1.3% 1/77 • Number of events 1
Injury, poisoning and procedural complications pneumothorax	0.91% 1/110 • Number of events 1	0.00% 0/77
Injury, poisoning and procedural complications LV lead dislodgement	1.8% 2/110 • Number of events 2	2.6% 2/77 • Number of events 2
Injury, poisoning and procedural complications Atrial Lead Dislodgement	0.00% 0/110	1.3% 1/77 • Number of events 1
Injury, poisoning and procedural complications coronary sinus staining during venography	0.91% 1/110 • Number of events 1	1.3% 1/77 • Number of events 1
Injury, poisoning and procedural complications diaphragmatic stimulation from LV pacing requiring device reprogramming	1.8% 2/110 • Number of events 2	2.6% 2/77 • Number of events 2

Additional Information

Dr. Samir Saba

University of Pittsburgh

Phone: 412-802-3372

Email: sabas@upmc.edu

Results disclosure agreements

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