HIS-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy
Completed · Not applicable
Conditions studied: Heart Failure，Congestive, Cardiomyopathies, Left Ventricular Dysfunction
In brief
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.
Key facts
- Study ID
- NCT04561778
- Run by
- Pugazhendhi Vijayaraman
- People needed
- 100
- Starts
- 2021-04-15
- Expected to finish
- 2023-09-30
- Last updated by the study team
- 2024-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Geisinger Health — Danville, Pennsylvania, United States
Full record on ClinicalTrials.gov
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