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The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter Ablation Treatment | Experimental | Cryoablation System: Atrial Fibrillation Ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation System | Device | Pulmonary Vein Isolation, Posterior Wall Isolation. May Include Mitral Line ablation, AF Driver ablation, and Cavo-tricuspid Isthmus ablation as indicated |
| Measure | Description | Time Frame |
|---|---|---|
| The primary safety endpoint will be determined by evaluating the incidence of procedural adverse events. | 1 day | |
| The primary safety endpoint will be determined by evaluating the incidence of serious adverse events within 7 days of procedure | 7 days | |
| The primary safety endpoint will be determined by evaluating the incidence of serious adverse events > 7 days after the procedure | 30 days | |
| The primary safety endpoint will be determined by evaluating the incidence of serious adverse events > 30 days after the procedure | 12 months | |
| Technical performance assessed by complete electrical isolation of all pulmonary veins (entrance block). | 1 day | |
| Technical performance assessed by AF termination targeting driver regions, when applicable | 1 day | |
| Technical performance assessed by complete linear block of linear lesions if deployed | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Performance assessed by percentage of RF focal ablation (touch up) to reach the primary performance endpoint. | 1 day | |
| Performance assessed by procedural fluoroscopy times | 1 day | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Hospital | Aalst | 9300 | Belgium | |||
| Cardiology Hospital of Haut-Lévêque |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40150915 | Derived | Abeln BGS, Addeo L, De Potter T, Boersma LVA. Durability of Ultra-Low Temperature Cryoablation Lesions in Atrial Fibrillation: Insights From Repeat Ablation Procedures. J Cardiovasc Electrophysiol. 2025 Jun;36(6):1264-1271. doi: 10.1111/jce.16665. Epub 2025 Mar 27. | |
| 34196991 | Derived | Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, Cabrita D, Fabbricatore D, Boersma LVA. Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2025-2032. doi: 10.1111/jce.15142. Epub 2021 Jul 9. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Performance assessed by ablation times |
| 1 day |
| Performance assessed by total procedure times) | 1 day |
| Performance assessed by complete freedom from documented AF or other atrial tachycardia (>30s), using a Holter monitor at 6-, 9-, and 12 months post ablation, after a single procedure and off AAD (following a 3 month blanking period). | 12 months |
| Pessac |
| 33600 |
| France |
| St. Antonius Hospital | Nieuwegein | Netherlands |
| D013568 |
| Pathological Conditions, Signs and Symptoms |