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NCT01985802 · ClinicalTrials.gov registry record · NA
Pacing in First-degree AV-block
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT01985802 is a NA study that has completed, run by Duke University. The registered enrollment target is 20 participants.
The verdict
NCT01985802, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to explore if there is a less harmful way to pace patients with first-degree AV-block to ensure that the negative effects inferred by the pacing do not outweigh the positive effects of AV-synchrony. The main hypothesis of the study is that His-bundle pacing will offer a more physiological mode of pacing in patients with first-degree AV-block than conventional pacing. Patients scheduled for catheter ablation of atrial fibrillation (AF) in sinus rhythm, with first degree AV-block, normal QRS duration less than 120 ms and normal left ventricular ejection fraction will be included. During the AF ablation three different pacing modes (atrial, AV-synchronous and His-bundle pacing) at two different rates (5 to10 bpm above the basal rate and at 100 bpm) will be performed and evaluated using echocardiography. After the completion of all six pacing protocols (i.e., three modes at two different rates) the experimental part of the procedure ends. The primary end-point will be echocardiographic evidence of dyssynchrony. Secondary end-points will include left ventricular ejection fraction, left ventricular volume, mitral regurgitation, septal to posterior wall motion delay and inter-ventricular wall motion delay. Since the research study is conducted in parallel with the standard catheter ablation, we do not anticipate any additional side effects as a result of the study.
Interventions
- OTHER Pacing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-12 |
| Est. Completion | 2017-10-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01985802
The ClinicalTrials.gov registry entry for NCT01985802 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pacing is the first listed.
NCT01985802 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01985802 about?
NCT01985802 is a clinical study titled "Pacing in First-degree AV-block". The purpose of this study is to explore if there is a less harmful way to pace patients with first-degree AV-block to ensure that the negative effects inferred by the pacing do not outweigh the positive effects of AV-synchrony. The main hypothesis of the study is that His-bundle pacing will offer a ...
What is the current status of trial NCT01985802?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2015-12. Estimated completion is 2017-10-26.
What interventions are being tested in trial NCT01985802?
The interventions under investigation include: Pacing (OTHER).
Who is sponsoring clinical trial NCT01985802?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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