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Biventricular Versus Right Ventricular Pacing

NCT ID: NCT06298669

Last Updated: 2024-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-09

Study Completion Date

2023-11-10

Brief Summary

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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

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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

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Heart Failure

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Biventricular Pacing followed by Right Ventricular Pacing

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.

Group Type EXPERIMENTAL

Biventricular Pacing

Intervention Type DEVICE

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

Right Ventricular Pacing

Intervention Type DEVICE

The CRT device will be reprogrammed for right ventricular contractions.

Right Ventricular Pacing followed by Biventricular Pacing

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.

Group Type EXPERIMENTAL

Biventricular Pacing

Intervention Type DEVICE

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

Interventions

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Biventricular Pacing

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

Intervention Type DEVICE

Right Ventricular Pacing

The CRT device will be reprogrammed for right ventricular contractions.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Maya Guglin

Professor of Clinical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16052

Identifier Type: -

Identifier Source: org_study_id