Biventricular Versus Right Ventricular Pacing

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT06298669
• Other study ID #: 10652
• Status: Suspended
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 28
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Biventricular Pacing
The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.
• Right Ventricular Pacing
The CRT device will be reprogrammed for right ventricular contractions.

Locations

Country	Name	City	State
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minute Walk Test Performance	The distance walked over 6 minutes will be measured.	Baseline, 3 Months, and 6 Months
Secondary	Serum NT-PRO-BNP	Serum levels of N-terminal pro-brain naturetic peptide (NT-PRO-BNP) will be measured.	Baseline, 3 Months, and 6 Months
Secondary	EQ-5D-3L	Quality of Life, as measured by the EQ-5D-3L questionnaire will be measured. 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.	Baseline, 3 Months, and 6 Months