Trial Outcomes & Findings for Biventricular Versus Right Ventricular Pacing (NCT NCT06298669)

NCT ID: NCT06298669

Last Updated: 2024-12-10

Results Overview

The distance walked over 6 minutes was measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: Baseline visit; Three-month visit
• Results posted on: 2024-12-10

Participant Flow

Participant milestones

Measure	Biventricular Pacing Followed by Right Ventricular Pacing Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality. Biventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles. Right Ventricular Pacing: The CRT device will be reprogrammed for right ventricular contractions.	Right Ventricular Pacing Followed by Biventricular Pacing Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to RV-first will have their CRT device reprogrammed to RV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to BiV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality. Biventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.
First Intervention (Three Months) STARTED	1	0
First Intervention (Three Months) COMPLETED	0	0
First Intervention (Three Months) NOT COMPLETED	1	0
Second Intervention (Three Months) STARTED	0	0
Second Intervention (Three Months) COMPLETED	0	0
Second Intervention (Three Months) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Biventricular Versus Right Ventricular Pacing

Baseline characteristics by cohort

Measure	Biventricular Pacing Followed by Right Ventricular Pacing n=1 Participants Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality. Biventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles. Right Ventricular Pacing: The CRT device will be reprogrammed for right ventricular contractions.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline visit; Three-month visit

The distance walked over 6 minutes was measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.

Outcome measures

Measure	Biventricular Pacing Followed by Right Ventricular Pacing n=1 Participants Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality. Biventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles. Right Ventricular Pacing: The CRT device will be reprogrammed for right ventricular contractions.
6 Minute Walk Test Performance Baseline visit	350 meters
6 Minute Walk Test Performance Three month visit	375 meters

SECONDARY outcome

Timeframe: Baseline visit

Quality of Life was measured using the EQ-5D-3L questionnaire. The EQ-5D-3L asks participants to rate the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated as either no problems (score of 1), some problems (score of 2), or extreme problems (score of 3). Higher scores indicating a poorer overall quality of life in these dimensions. Scores on the five dimensions are summarized to create an index score. The EQ-5D-3L index score is a numerical value that summarizes a person's health state on a scale from -0.594 to 1:

• 1: Full health
• 0 or less: Equivalent to being dead or worse than dead

The questionnaire was only completed at the baseline visit for the single participant on study.

Outcome measures

Measure

Biventricular Pacing Followed by Right Ventricular Pacing n=1 Participants Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality. Biventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles. Right Ventricular Pacing: The CRT device will be reprogrammed for right ventricular contractions.

EQ-5D-3L Quality of Life Score

-0.293 score on a scale

SECONDARY outcome

Timeframe: Baseline visit; Three-month visit

Serum levels of N-terminal pro-brain natriuretic peptide (NT-PRO-BNP) were measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.

Outcome measures

Measure	Biventricular Pacing Followed by Right Ventricular Pacing n=1 Participants Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality. Biventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles. Right Ventricular Pacing: The CRT device will be reprogrammed for right ventricular contractions.
Serum NT-PRO-BNP Three-month visit	515 pg/mL
Serum NT-PRO-BNP Baseline visit	470 pg/mL

Adverse Events

Biventricular Pacing Followed by Right Ventricular Pacing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maya Guglin

Rutgers

Phone: 9085968459

Email: maya.guglin@rutgers.edu

Results disclosure agreements

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