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NCT03008291 · ClinicalTrials.gov registry record
His Bundle Pacing in Bradycardia and Heart Failure
A clinical trial of Heart Failure and Bradycardia, sponsored by Yong-Mei Cha.
- Recruiting
- Registry status
- 80
- Enrollment target
- 1
- Study location
NCT03008291: Recruiting study of Heart Failure and Bradycardia, sponsored by Yong-Mei Cha.
NCT03008291 is a study of Heart Failure and Bradycardia that is actively recruiting participants, run by Yong-Mei Cha. The registered enrollment target is 80 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03008291, a study of Heart Failure and Bradycardia, is actively recruiting participants, sponsored by Yong-Mei Cha.
- RECRUITING
- Registry status
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
Participants in this study will either have heart failure (HF) and are scheduled to undergo pace maker (PM) implantation, cardiac resynchronization therapy pacemaker (CRT-P), cardiac resynchronization therapy defibrillator (CRT-D) implantation, His bundle pacing (HIBP) or left bundle area pacing (LBAP) (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders), or have atrioventricular (AV) block or bradycardia and are scheduled to undergo dual chamber pacemaker implantation. In this study additional heart rhythm measurements will be collected during the implant procedure to better understand how His bundle and/or parahisian pacing (HISP) effects electrical conduction in the hearts of patients with HF or AV block. The hypothesis is that His bundle or parahisian pacing (HISP) and left bundle area pacing (LBAP) may normalize atrioventricular (AV) conduction with a narrow combination of the Q wave, R wave and S wave (QRS complex) in functional bundle branch block or conduction delay in patients with heart failure (HF).
Primary Outcome
The normal duration (interval) of the QRS complex is 0.08 and 0.10 seconds (80 and 100 ms). When the duration is between 0.10 and 0.12 seconds it is intermediate or slightly prolonged. A QRS duration of greater than 0.12 seconds is considered abnormal.
Conditions Studied
Interventions
- PROCEDURE CRT-D Implantation
- PROCEDURE CRT-P Implantation
- PROCEDURE Dual Chamber Pacemaker Implantation
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2016-10 |
| Est. Completion | 2026-12 |
What NCT03008291 shows while recruiting
NCT03008291 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 3 interventions - of which CRT-D Implantation is the first listed.
NCT03008291 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03008291 about?
NCT03008291 is a clinical study titled "His Bundle Pacing in Bradycardia and Heart Failure". Participants in this study will either have heart failure (HF) and are scheduled to undergo pace maker (PM) implantation, cardiac resynchronization therapy pacemaker (CRT-P), cardiac resynchronization therapy defibrillator (CRT-D) implantation, His bundle pacing (HIBP) or left bundle area pacing (LB...
What is the current status of trial NCT03008291?
This trial is currently recruiting. The enrollment target is 80 participants. The study started on 2016-10. Estimated completion is 2026-12.
What conditions does trial NCT03008291 study?
This clinical trial studies the following conditions: Heart Failure, Bradycardia.
What interventions are being tested in trial NCT03008291?
The interventions under investigation include: CRT-D Implantation (PROCEDURE), CRT-P Implantation (PROCEDURE), Dual Chamber Pacemaker Implantation (PROCEDURE).
Who is sponsoring clinical trial NCT03008291?
This trial is sponsored by Yong-Mei Cha, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03008291 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03008291's enrollment target sits among peer trials
80 229th of 397 higher than 167 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure 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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