Trials / Terminated
TerminatedNCT05416086
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 91 (actual)
- Sponsor
- Adagio Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL).
Detailed description
This Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical iCLAS™ Cryoablation System in real world clinical settings.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | cryoablation procedure using the iCLAS Cryoablation System | all subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon |
Timeline
- Start date
- 2021-09-03
- Primary completion
- 2025-01-28
- Completion
- 2025-01-28
- First posted
- 2022-06-13
- Last updated
- 2026-04-13
Locations
4 sites across 3 countries: Belgium, Germany, Netherlands
Source: ClinicalTrials.gov record NCT05416086. Inclusion in this directory is not an endorsement.