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Adaptive Cardiac Resynchronization Therapy in Patients With RBBB

NCT05936294 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-07-07

No results posted yet for this study

Summary

This study will address whether acute adaptive RV pacing in sinus rhythm patients with severe LV systolic dysfunction and RBBB is superior to no ventricular pacing, and is as effective as echocardiographically optimized biventricular (BIV) pacing based on Medtronic ECG belt and cardiac performance as assessed by the echocardiographic parameters of RV and LV function.

Conditions

  • Right Bundle-Branch Block

Interventions

DIAGNOSTIC_TEST

Optimization of CRT Device

Each patient will have atrial pacing 10% higher than the sinus rate or atrial pacing at a rate of 60 bpm if significant sinus bradycardia is present. Each patient will have six ECGs and echocardiographic sequences performed in the same session. In addition six electrical activation evaluations by the Medtronic ECG belt will be done as well. The first study will always be with no ventricular pacing. One study will be echocardiography-optimized BIV pacing and four studies for echocardiography-optimized (?) adaptive RV-only pacing with different AV intervals. A random-sequence will be performed to determine the order for the rest of the studies.

Sponsors & Collaborators

  • Central Arkansas Veterans Healthcare System

    collaborator FED

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Waddah Maskoun, MD · Henry Ford

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05936294 on ClinicalTrials.gov