Biventricular Versus Right Ventricular Pacing
- Conditions
- Heart Failure
- 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
- Patients with both an LVAD and CRT device with functional leads
- Age 18 years and older
- Ability to walk
- Ability to sign consent
- Patients with permanent atrial fibrillation
- Patients who are pacemaker dependent
- Patients with sustained ventricular tachycardia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- 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.
Trial Locations
- Locations (1)
Indiana University Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Indiana University Health Methodist Hospital🇺🇸Indianapolis, Indiana, United States