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NCT04061603
iCLAS™ for Persistent Atrial Fibrillation
NA trial testing Adagio AF Cryoablation System (iCLAS™) in Persistent Atrial Fibrillation in 215 participants. Completed in 30 August 2024.
30 August 2023
Quick facts
| Lead sponsor | Adagio Medical |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 215 |
| Start date | 9 December 2019 |
| Primary completion | 30 August 2023 |
| Estimated completion | 30 August 2024 |
| Sites | 21 locations across Belgium, Netherlands, Canada, United States |
Drugs / interventions tested
- Adagio AF Cryoablation System (iCLAS™)
Conditions studied
- Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →
Sponsor
Adagio Medical — full company profile →
Who can join
Adults 18 to 80, any sex, with Persistent Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results.
Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, et al · · 2021 · cited 10× · PMID 34196991 · DOI 10.1111/jce.15142
Verify or expand the search:
- PubMed search for NCT04061603
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Persistent Atrial Fibrillation
Currently open trials in the same condition.
- NCT07298473 — Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sp · NA · recruiting
- NCT07535268 — REPRESENT-PF Registry · recruiting
- NCT07508618 — Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule · Phase 4 · recruiting
- NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting
- NCT07106970 — PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II) · 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
- NCT05416086 — iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study · NA · terminated
- NCT04893317 — Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT) · 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 NCT04061603 (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/NCT04061603.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing