CompletedNot Applicable

iCLAS™ for Persistent Atrial Fibrillation

United States215 participantsStarted 2019-12-09

Plain-language 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)

Who can participate

Age range18 Years – 80 Years

SexALL

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Exclusion criteria

✕. Left ventricular ejection fraction (LVEF) \< 40% based on most recent TTE
✕. Left atrial size \> 55 mm (parasternal long axis view) documented within 6-months of screening
✕. NYHA Class III or IV heart failure documented within the previous 12-months
✕. An implanted pacemaker or ICD
✕. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG),
✕. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve
✕. Interatrial baffle, closure device, patch, or PFO occluder
✕. Presence of a left atrial appendage occlusion device

What they're measuring

Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure.

Timeframe: 12-months

Analysis of the proportion of subjects receiving a single cryoablation who are free from any documented left atrial arrhythmia (AF/AFL/AT).

Timeframe: 12-months

Trial details

NCT IDNCT04061603

SponsorAdagio Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-30

View on ClinicalTrials.gov More Persistent Atrial Fibrillation trials