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His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy

NCT02700425 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-09-05

Study results available
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Summary

The goal of this study is to compare the effectiveness of pacing from a physiologic His bundle (HB) lead position versus with the standard coronary sinus (CS) lead position in subjects with heart failure undergoing cardiac resynchronization therapy (CRT). While placement of left ventricular leads via the coronary sinus has anatomic limitations, we hypothesis that the achievement of QRS narrowing with His bundle capture will be superior for improving systolic function by echocardiographic indices (ejection fraction and strain) and quality of life and decreased rehospitalization and mortality.

Conditions

  • Congestive Heart Failure

Interventions

DEVICE

CRT Pacemaker

Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.

Sponsors & Collaborators

  • University of California, Los Angeles

    collaborator OTHER

  • Northwestern University

    collaborator OTHER

  • Rush University Medical Center

    collaborator OTHER

  • Geisinger Clinic

    collaborator OTHER

  • Indiana University

    collaborator OTHER

  • Edward Hospital

    collaborator OTHER

  • Baptist Health, Louisville

    collaborator OTHER

  • University of Chicago

    lead OTHER

Principal Investigators

  • Roderick Tung, MD · University of Chicago

  • Gaurav A. Upadhyay, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-17
Primary Completion
2020-07-31
Completion
2020-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02700425 on ClinicalTrials.gov