CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
CRT Pacemakerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02700425
NCT02700425N/ACompleted
CompareCT.gov

His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy

University of Chicago·interventional·Posted Mar 7, 2016·Updated Sep 5, 2021

In Brief

A clinical study evaluating CRT Pacemaker for Congestive Heart Failure. Completed, enrolled 41 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongestive Heart Failure
CountriesUnited States
CollaboratorsUniversity of California, Los Angeles, Northwestern University, Rush University Medical Center, Geisinger Clinic, Indiana University, Edward Hospital, Baptist Health, Louisville

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 7, 2016
Enrollment StartMay 17, 2016
Primary CompletionJul 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 10.3 years ago

Interventions

CRT Pacemakerdevice

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.