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NCT04061603 · ClinicalTrials.gov registry record · NA
iCLAS™ for Persistent Atrial Fibrillation
A NA study, sponsored by Adagio Medical.
- Completed
- Registry status
- NA
- Development phase
- 215
- Enrollment target
NCT04061603: Completed NA study, sponsored by Adagio Medical.
NCT04061603 is a NA study that has completed, run by Adagio Medical. The registered enrollment target is 215 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04061603, a NA study, has completed, sponsored by Adagio Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 215 participants
- Enrollment target
Study Summary
Clinical study to evaluate the safety and efficacy of the Adagio AF Cryoablation System (iCLAS™) in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF). Data will be used to support a pre-market application (PMA)
Primary Outcome
Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure. MAEs include any of the following: * Death * Myocardial infarction * Cardiac perforation/pericardial tamponade * Cerebral infarct or systemic embolism * Major bleeding requiring transfusion of blood products * Mitral or tricuspid valve damage * Symptomatic pulmonary vein stenosis * Severe (≥ 70%) pulmonary vein stenosis * Permanent phreni
Interventions
- DEVICE Adagio AF Cryoablation System (iCLAS™)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2019-12-09 |
| Est. Completion | 2024-08-30 |
| Phase | NA |
What the finished NCT04061603 record still lists
NCT04061603 is an interventional study that assigns participants to a tested intervention. The registered 215 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 (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Adagio AF Cryoablation System (iCLAS™) is the first listed.
NCT04061603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04061603 about?
NCT04061603 is a clinical study titled "iCLAS™ for Persistent Atrial Fibrillation". Clinical study to evaluate the safety and efficacy of the Adagio AF Cryoablation System (iCLAS™) in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF). Data will be used to support a pre-market application (PMA)
What is the current status of trial NCT04061603?
This trial is currently completed. It is a NA study. The enrollment target is 215 participants. The study started on 2019-12-09. Estimated completion is 2024-08-30.
What interventions are being tested in trial NCT04061603?
The interventions under investigation include: Adagio AF Cryoablation System (iCLAS™) (DEVICE).
Who is sponsoring clinical trial NCT04061603?
This trial is sponsored by Adagio Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04061603's enrollment target sits among peer trials
215 487th of 2000 higher than 1,514 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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