N/A
N=41
His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy
Congestive Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02700425 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Change in Left Ventricular Ejection Fraction (LVEF) — 26.3; 30.5; 31.9; 34.0 ejection fraction percentage — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CRT Pacemaker (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular Ejection Fraction (LVEF) |
26.3; 30.5; 31.9; 34.0 | <0.001 sig |
| PRIMARY Change in QRS Duration |
172; 165; 144; 152 | 0.002 sig |
| PRIMARY Time to First Cardiovascular Hospitalization or Death |
10.63; 11.58 | 0.62 |
| SECONDARY New York Heart Association (NYHA) Functional Class Change |
3.0; 2.5; 2.0; 2.0; 3.0; 2.0 | 0.09 |
| SECONDARY Quality of Life Change by Kansas City Questionnaire (KCCQ) |
65; 70; 44; 85 | 0.35 |
| SECONDARY Time to First Cardiovascular Rehospitalization |
10.63; 11.58 | 0.14 |
| SECONDARY Time to First Treated Ventricular Arrhythmia/Ventricular Tachycardia (VT/VF) |
10.63; 11.58 | 0.14 |
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.
Eligibility Criteria
Inclusion Criteria
- Patients at least 18 years of age
- LV systolic dysfunction with LVEF ≤ 35%
- Evidence of intraventricular conduction delay with QRS duration > 120 msec
- NYHA Class II, III, and ambulatory Class IV heart failure with either ischemic or nonischemic cardiomyopathy and patients with NYHA Class I symptoms and ischemic cardiomyopathy
- Left ventricular ejection fraction (LVEF) ≤ 35%, sinus rhythm (SR), left bundle-branch block (LBBB) morphology, and QRS duration ≥ 150 msec, and NYHA Class II, III, or ambulatory Class IV patients on goal-directed medical therapy (GDMT) [Class I]
- LVEF ≤ 35%, SR with LBBB with QRS 120-149 msec on GDMT [Class IIa]
- LVEF ≤ 35%, SR with non-LBBB with QRS ≥ 150 msec on GDMT [Class IIa]
- LVEF ≤ 35%, in AF if medication or AV nodal ablation will allow near 100% pacing [Class IIa]
- LVEF ≤ 35% undergoing new or replacement device with anticipated >40% ventricular pacing on GDMT [Class IIa]
- LVEF ≤ 30%, ischemic etiology of HF, SR with LBBB ≥ 150 msec and NYHA Class I symptoms on GDMT [Class IIb]
- LVEF ≤ 35%, SR with non-LBBB with QRS 120-149 msec, NYHA Class III/ambulatory Class IV HF on GDMT [Class IIb] LVEF ≤ 35%, SR with non-LBBB with QRS ≥ 150 msec, NYHA Class II HF on GDMT [Class IIb]
Exclusion Criteria
- Existing CRT device
- Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
- Pregnancy
- Participation in other trials
- Difficulty with follow-up
Data sourced from ClinicalTrials.gov (NCT02700425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.