Biventricular Versus Right Ventricular Pacing
November 15, 2024 updated by: Maya Guglin, Indiana University
Selection of Cardiac Resynchronization Therapy Pacing Modalities in Patients Supported by LVADs
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Health Methodist Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.
The CRT device will be reprogrammed for right ventricular contractions.
|
|
Experimental: 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.
|
The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6 Minute Walk Test Performance
Time Frame: Baseline visit; Three-month visit
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EQ-5D-3L Quality of Life Score
Time Frame: Baseline visit
|
Quality of Life was measured using the EQ-5D-3L questionnaire. 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. Scores on the five dimensions are summarized to create an index score. The EQ-5D-3L index score is a numerical value that summarizes a person's health state on a scale from -0.594 to 1:
The questionnaire was only completed at the baseline visit for the single participant on study. |
Baseline visit
|
|
Serum NT-PRO-BNP
Time Frame: Baseline visit; Three-month visit
|
Serum levels of N-terminal pro-brain natriuretic peptide (NT-PRO-BNP) were 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2023
Primary Completion (Actual)
November 10, 2023
Study Completion (Actual)
November 10, 2023
Study Registration Dates
First Submitted
March 1, 2024
First Submitted That Met QC Criteria
March 1, 2024
First Posted (Actual)
March 7, 2024
Study Record Updates
Last Update Posted (Estimated)
December 10, 2024
Last Update Submitted That Met QC Criteria
November 15, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.