NCT04893317

Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)

Cryoablation for Monomorphic Ventricular Tachycardia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Adagio Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study subjects will include patients who experience recurrent monomorphic VT and are scheduled for an endocardial VT ablation. Study subjects have or will have an Implantable Cardioverter Defibrillator (ICD) prior to hospital discharge following the cryoablation procedure. A VT ablation procedure is performed by finding the abnormal ventricular heart tissue that is causing the VT and applying energy with an ablation catheter to the area. The goal is to apply energy to create a scar or destroy the tissue that causes the VT, such that VT is no longer present or inducible.

Conditions

• Monomorphic Ventricular Tachycardia

Interventions

Type	Name	Description
DEVICE	Ablation in the ventricles with the Adagio Medical VT Cryoablation System	The Adagio Medical VT Cryoablation System is indicated for the treatment of monomorphic ventricular tachycardia by ablation of arrhythmogenic tissue that drives and maintains these arrhythmias

Timeline

• Start date: 2021-05-26
• Primary completion: 2024-06-30
• Completion: 2024-09-30
• First posted: 2021-05-19
• Last updated: 2026-03-19

Locations

7 sites across 6 countries: Belgium, Canada, Czechia, France, Germany, Netherlands