N/A
N=100
HIS-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy
Heart Failure，Congestive · Cardiomyopathies · Left Ventricular Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT04561778 ↗Enrolled (actual)
100
Serious AEs
49.0%
Results posted
Aug 2024
Primary outcome: Primary: Primary Endpoint — 12.4; 8.0 percent ejection fraction
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HOT-CRT (Device); Biventricular Pacing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pugazhendhi Vijayaraman
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Endpoint |
12.4; 8.0 | — |
| PRIMARY Primary Safety |
49; 48 | — |
| SECONDARY Secondary Composite |
9; 14 | — |
| SECONDARY Echocardiographic Response |
35; 27 | — |
Summary
This is a randomized, prospective, single-blinded trial to determine the overall rate of successful His-Purkinje conduction system pacing Optimized Trial of Cardiac Resynchronization Therapy (HOT-CRT) versus biventricular pacing using coronary sinus lead (BVP) to compare acute and mid-term outcomes. Acute outcomes include change in QRS duration pre-and post-pacing (degree of QRS narrowing) and incidence of major periprocedural complications (pericardial tamponade, need for lead revision, etc.). Mid-term outcomes include echocardiographic response at 6 months along with a composite clinical outcome of heart failure hospitalization, ventricular arrhythmias, crossover, and all-cause mortality.
Eligibility Criteria
Inclusion Criteria
- Patients at least 18 years of age
- Diagnosis is 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, with at least one of the following:
- LV systolic dysfunction with LVEF ≤ 35% and Evidence of bundle branch block with QRS duration > 120 msec
- LV systolic dysfunction with LVEF ≤ 50% and with need for >40% Right Ventricular (RV) pacing
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 device trials
- Inability to complete study requirements
Data sourced from ClinicalTrials.gov (NCT04561778). 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.