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NCT03775512 · ClinicalTrials.gov registry record · NA
Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
A NA study, sponsored by Biosense Webster.
- Completed
- Registry status
- NA
- Development phase
- 283
- Enrollment target
NCT03775512: Completed NA study, sponsored by Biosense Webster.
NCT03775512 is a NA study that has completed, run by Biosense Webster. The registered enrollment target is 283 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03775512, a NA study, has completed, sponsored by Biosense Webster.
- COMPLETED
- Registry status
- NA
- Development phase
- 283 participants
- Enrollment target
Study Summary
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A Primary AEs is an event which occurred within 90 days following initial and repeated ablation procedure using the QDOT MICRO. Primary AEs included: atrio-esophageal fistula and pulmonary vein stenosis.
Interventions
- DEVICE RF Ablation with QDOT Micro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2019-01-30 |
| Est. Completion | 2022-02-17 |
| Phase | NA |
What the finished NCT03775512 record still lists
NCT03775512 is an interventional study that assigns participants to a tested intervention. The registered 283 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 (80% lower).
The record links to 0 conditions, and to 1 intervention - of which RF Ablation with QDOT Micro is the first listed.
NCT03775512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03775512 about?
NCT03775512 is a clinical study titled "Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation". Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.
What is the current status of trial NCT03775512?
This trial is currently completed. It is a NA study. The enrollment target is 283 participants. The study started on 2019-01-30. Estimated completion is 2022-02-17.
What interventions are being tested in trial NCT03775512?
The interventions under investigation include: RF Ablation with QDOT Micro (DEVICE).
Who is sponsoring clinical trial NCT03775512?
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 NCT03775512's enrollment target sits among peer trials
283 378th of 2000 higher than 1,622 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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