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NCT03683030 · ClinicalTrials.gov registry record · Phase 3
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
A Phase 3 study, sponsored by Biosense Webster.
- Completed
- Registry status
- Phase 3
- Development phase
- 397
- Enrollment target
NCT03683030: Completed Phase 3 study, sponsored by Biosense Webster.
NCT03683030 is a Phase 3 study that has completed, run by Biosense Webster. The registered enrollment target is 397 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03683030, a Phase 3 study, has completed, sponsored by Biosense Webster.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 397 participants
- Enrollment target
Study Summary
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
Primary Outcome
An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. PAEs included myocardial infarction, thromboembolism, transient ischemic attack, phrenic nerve paralysis, major vascular access complication/bleeding, pericarditis, pulmonary edema (respiratory insufficiency), stroke/cerebrovascular accident (CVA), hospitalization (initial or prolonged), device or procedure related death, atrio-esophageal fistula, pulmonary vein stenosis.
Interventions
- DEVICE Multi-Electrode RF Balloon Catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 397 participants |
| Start Date | 2018-10-22 |
| Est. Completion | 2022-02-18 |
| Phase | Phase 3 |
What the finished NCT03683030 record still lists
NCT03683030 is an interventional study that assigns participants to a tested intervention. The registered 397 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 1 intervention - of which Multi-Electrode RF Balloon Catheter is the first listed.
NCT03683030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03683030 about?
NCT03683030 is a clinical study titled "Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation". The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
What is the current status of trial NCT03683030?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 397 participants. The study started on 2018-10-22. Estimated completion is 2022-02-18.
What interventions are being tested in trial NCT03683030?
The interventions under investigation include: Multi-Electrode RF Balloon Catheter (DEVICE).
Who is sponsoring clinical trial NCT03683030?
This trial is sponsored by Biosense Webster, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03683030's enrollment target sits among peer trials
397 964th of 2000 higher than 1,037 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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