NCT06298669

Biventricular Versus Right Ventricular Pacing

Selection of Cardiac Resynchronization Therapy Pacing Modalities in Patients Supported by LVADs

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Biventricular Pacing	The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.
DEVICE	Right Ventricular Pacing	The CRT device will be reprogrammed for right ventricular contractions.

Timeline

• Start date: 2023-08-09
• Primary completion: 2023-11-10
• Completion: 2023-11-10
• First posted: 2024-03-07
• Last updated: 2024-12-10
• Results posted: 2024-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study