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NCT04561778 · ClinicalTrials.gov registry record · NA
HIS-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy
A NA study, sponsored by Pugazhendhi Vijayaraman.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT04561778: Completed NA study, sponsored by Pugazhendhi Vijayaraman.
NCT04561778 is a NA study that has completed, run by Pugazhendhi Vijayaraman. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04561778, a NA study, has completed, sponsored by Pugazhendhi Vijayaraman.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
Improvement in left ventricular ejection fraction (LVEF) - change in LVEF% measured by 2D echo at 6 months compared to baseline
Interventions
- DEVICE HOT-CRT
- DEVICE Biventricular Pacing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-04-15 |
| Est. Completion | 2023-09-30 |
| Phase | NA |
What the finished NCT04561778 record still lists
NCT04561778 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which HOT-CRT is the first listed.
NCT04561778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04561778 about?
NCT04561778 is a clinical study titled "HIS-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy". 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....
What is the current status of trial NCT04561778?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2021-04-15. Estimated completion is 2023-09-30.
What interventions are being tested in trial NCT04561778?
The interventions under investigation include: HOT-CRT (DEVICE), Biventricular Pacing (DEVICE).
Who is sponsoring clinical trial NCT04561778?
This trial is sponsored by Pugazhendhi Vijayaraman, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04561778's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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