Biventricular Versus Right Ventricular Pacing

Not Applicable

Terminated

Conditions: Heart Failure

Interventions: Device: Biventricular Pacing
Device: Right Ventricular Pacing

Registration Number: NCT06298669

Lead Sponsor: Indiana University

Brief Summary: The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test.

Detailed Description: Heart failure patients with reduced left ventricular systolic function and worsening clinical status are frequently treated with mechanical devices. Cardiac resynchronization therapy (CRT) and left ventricular assist devices (LVAD) are mainstays of advanced heart failure treatment and have independently been demonstrated to decrease mortality. However, minimal research documents the utility of these two modalities in unison. There have been recent investigations comparing Biventricular (BiV) versus right ventricular (RV) pacing suggesting better exercise performance and decreased left ventricular (LV) volumes with RV pacing. This discovery contrasts with prior meta-analysis that reports no difference between LVAD patients with and without CRT including mortality and hospitalizations. Investigators aim to compare BiV pacing and RV pacing in LVAD patients with CRT on patient's exercise tolerance and frequency of tachyarrhythmias. Additionally, research is required to form a conclusion on the role of CRT in LVAD patients.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

Inclusion Criteria

Patients with both an LVAD and CRT device with functional leads
Age 18 years and older
Ability to walk
Ability to sign consent

Exclusion Criteria

Patients with permanent atrial fibrillation
Patients who are pacemaker dependent
Patients with sustained ventricular tachycardia

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biventricular Pacing followed by Right Ventricular Pacing	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 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 followed by Right Ventricular Pacing	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.
Right Ventricular Pacing followed by Biventricular Pacing	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.

Primary Outcome Measures

Name	Time	Method
6 Minute Walk Test Performance	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.

Secondary Outcome Measures

Name	Time	Method
EQ-5D-3L Quality of Life Score	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.
Serum NT-PRO-BNP	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.