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NCT05416086
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
NA trial testing cryoablation procedure using the iCLAS Cryoablation System in Atrial Fibrillation in 91 participants. Terminated before completion.
28 January 2025
Quick facts
| Lead sponsor | Adagio Medical |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 91 |
| Start date | 3 September 2021 |
| Primary completion | 28 January 2025 |
| Estimated completion | 28 January 2025 |
| Sites | 4 locations across Belgium, Netherlands, Germany |
Drugs / interventions tested
- cryoablation procedure using the iCLAS Cryoablation System
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
- Atrial Flutter — all drugs for Atrial Flutter →
- Paroxysmal Atrial Fibrillation — all drugs for Paroxysmal Atrial Fibrillation →
- Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →
Sponsor
Adagio Medical — full company profile →
Who can join
18 and older, any sex, with Atrial Fibrillation or Atrial Flutter. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Durability of Ultra-Low Temperature Cryoablation Lesions in Atrial Fibrillation: Insights From Repeat Ablation Procedures.
Abeln BGS, Addeo L, De Potter T, Boersma LVA. · · 2025 · cited 1× · PMID 40150915 · DOI 10.1111/jce.16665
Verify or expand the search:
- PubMed search for NCT05416086
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Atrial Fibrillation
Currently open trials in the same condition.
- NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF · NA · recruiting
- NCT07271238 — Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures · NA · recruiting
- NCT07388108 — Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery. · recruiting
- NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function · NA · recruiting
- NCT06650995 — AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure · NA · recruiting
Other Adagio Medical trials
Trials by the same sponsor.
- NCT06384599 — VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study · NA · not yet recruiting
- NCT05675865 — Cryoablation for Monomorphic Ventricular Tachycardia · NA · recruiting
- NCT05408754 — Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation · NA · completed
- NCT04893317 — Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT) · NA · completed
- NCT04061603 — iCLAS™ for Persistent Atrial Fibrillation · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05416086 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Adagio Medical
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05416086.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing