Biventricular Versus Right Ventricular Pacing

NCT06298669 | Terminated Results FDA Device

• 1 other identifier: 16052
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Left Ventricular Assist Device (LVAD); Cardiac resynchronization therapy (CRT)

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test Performance

  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.

  Baseline visit; Three-month visit

Secondary Outcomes (2)

• EQ-5D-3L Quality of Life Score

  Baseline visit

• Serum NT-PRO-BNP

  Baseline visit; Three-month visit

Study Arms (2)

Biventricular Pacing followed by Right Ventricular Pacing

EXPERIMENTAL

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.

Device: Biventricular Pacing; Device: Right Ventricular Pacing

Right Ventricular Pacing followed by Biventricular Pacing

EXPERIMENTAL

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.

Device: Biventricular Pacing

Interventions

Biventricular Pacing DEVICE

The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.

Biventricular Pacing followed by Right Ventricular Pacing; Right Ventricular Pacing followed by Biventricular Pacing

Right Ventricular Pacing DEVICE

The CRT device will be reprogrammed for right ventricular contractions.

Biventricular Pacing followed by Right Ventricular Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with both an LVAD and CRT device with functional leads
• Age 18 years and older
• Ability to walk
• Ability to sign consent

You may not qualify if:

• Patients with permanent atrial fibrillation
• Patients who are pacemaker dependent
• Patients with sustained ventricular tachycardia

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Results Point of Contact

• Title: Maya Guglin
• Organization: Rutgers

maya.guglin@rutgers.edu

9085968459

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: August 9, 2023
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)