Biventricular Versus Right Ventricular Pacing

Indiana University

Status: Terminated

Conditions: Heart Failure

Treatments: Device: Right Ventricular Pacing; Device: Biventricular Pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT06298669

16052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Biventricular Pacing followed by Right Ventricular Pacing

Experimental group

Description:

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.

Treatment:

Device: Biventricular Pacing

Device: Right Ventricular Pacing

Right Ventricular Pacing followed by Biventricular Pacing

Experimental group

Description:

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.

Treatment:

Device: Biventricular Pacing