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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.

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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

FieldValue
Enrollment Target 397 participants
Start Date 2018-10-22
Est. Completion 2022-02-18
Phase Phase 3
Biosense Webster

18 total trials

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.

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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Source: ClinicalTrials.gov NCT03683030, the US trial registry maintained by the National Library of Medicine. NCT03683030 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.