CompletedNot Applicable

Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)

Belgium, Canada, Czechia64 participantsStarted 2021-05-26

Plain-language summary

A prospective, single-arm, multi-center, pre-market, clinical study designed to provide safety and performance data regarding the use of the Adagio Medical VT Cryoablation System in the treatment of ventricular tachycardia.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Class IV heart failure
✕. Aortic aneurysm
✕. Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to the procedure
✕. Interatrial baffle, closure device, patch, or PFO occlusion device
✕. IVC filter
✕. Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
✕. Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
✕. Cardiac myxoma

What they're measuring

Primary Endpoint for Safety

Timeframe: during and 30 days post cryoablation procedure

Primary Endpoint for Clinical Performance

Timeframe: 6 month post cryoablation procedure

Primary Endpoint for Procedure Performance

Timeframe: at the end of the cryoablation procedure

Trial details

NCT IDNCT04893317

SponsorAdagio Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Monomorphic Ventricular Tachycardia trials