NCT05675865

Cryoablation for Monomorphic Ventricular Tachycardia

Cryoablation for Monomorphic Ventricular Tachycardia IDE Study: EFS and Pivotal

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Adagio Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)

Detailed description

A prospective, single-arm, multi-center, open label, pre-market, clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of scar-mediated SMVT in ischemic and non-ischemic patients. Study subjects will include patients who experience recurrent SMVT and are scheduled for an endocardial VT ablation. Study subjects must have an Implantable Cardioverter Defibrillator (ICD) prior to the cryoablation procedure. This IDE study includes two phases, an early feasibility (EFS) phase to support initial device safety and effectiveness, and a Pivotal Study phase to collect safety and effectiveness data for a future PMA marketing application.

Conditions

• Sustained VT

Interventions

Type	Name	Description
DEVICE	cryoablation procedure	ablation procedure for VT using the investigational device

Timeline

• Start date: 2023-09-11
• Primary completion: 2027-01-31
• Completion: 2027-03-30
• First posted: 2023-01-09
• Last updated: 2026-04-07

Locations

15 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study