Cryoablation for Monomorphic Ventricular Tachycardia IDE Study: EFS and Pivotal
Adagio Medical
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)
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 P…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria (IC): * IC 1 Male or female ≥ 18 years * IC 2 Patients with a clinical indication for catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained scar-mediated monomorphic Ventricular Tachycardia. * IC 3 Any of the following: * Ischemic cardiomyopapthy (ICM) patients with prior history of myocardial infarction with Q waves, focal wall motion abnormality on imaging, fixed perfusion defect correlating with coronary stenosis or prior coronary intervention, 20% ≤ LVEF \< 50%. * non-ischemic cardiomyopathy (NICM) patients with sca…
Interventions
- Devicecryoablation procedure
ablation procedure for VT using the investigational device
Locations (15)
- Banner University Medical Center PhoenixPhoenix, Arizona
- University of California San FranciscoSan Francisco, California
- Johns Hopkins UniversityBaltimore, Maryland
- Brigham and Women's HospitalBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan
- Icahn School of Medicine at Mount SinaiNew York, New York