Selection of Cardiac Resynchronization Therapy Pacing Modalities in Patients Supported by LVADs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Indiana University
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- 6 Minute Walk Test Performance
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Maya Guglin
Professor of Clinical Medicine
Indiana University
Eligibility Criteria
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
Outcomes
Primary Outcomes
6 Minute Walk Test Performance
Time Frame: 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 Outcomes
- EQ-5D-3L Quality of Life Score(Baseline visit)
- Serum NT-PRO-BNP(Baseline visit; Three-month visit)