Cryoablation for Monomorphic Ventricular Tachycardia

Not Applicable

Recruiting

• Conditions: Sustained VT
• Interventions: Device: cryoablation procedure

• Registration Number: NCT05675865
• Lead Sponsor: Adagio Medical

Brief 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.

Study Timeline

• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-09
• Study Start: 2023-09-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-12-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VT Cryoablation	cryoablation procedure	all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for SMVT

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint for EFS and Pivotal phases is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation procedure.	7 days following the ablation procedure	Events will be adjudicated by an independent Clinical Events Committee (CEC). MAEs include any of the following: * Death; * Acute myocardial infarction; * Cardiac perforation/pericardial tamponade; * Cerebral infarct or systemic embolism; * Major bleeding requiring transfusion; * Acute Mitral, Tricuspid or Aortic valve damage resulting in moderate or severe regurgitation; * Access site complications requiring medical or surgical intervention; * Pericarditis; * Heart block requiring a permanent pacemaker; * Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) to be probably or definitely related to the Adagio System.
Primary Procedural Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with non-inducible VT or no further ablation targets meeting the criteria for ablation at the end of the cryoablation procedure.	During Procedure	Documentation of non-inducibility of any VT targeted for ablation at the end of procedure.
Primary Efficacy Endpoint for Pivotal Phase	6 months after the procedure	Defined as freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure, where sustained MMVT is defined as continuous MMVT for \> 30 seconds (programmed monitoring zone only), or MMVT requiring appropriate ICD intervention regardless of duration. All ICD interrogation reports will be adjudicated by an independent VT Event Committee (VTEC) to support the primary efficacy endpoint.

Secondary Outcome Measures

Name	Time	Method
Health Outcomes for EFS and Pivotal phases are defined as all-cause mortality at 12 months	12-months post cryoablation procedure	All-cause mortality at 12 months
Secondary Safety Endpoint - Analysis of the proportion of subjects with freedom from definite or probable device or procedure related MAEs that occur within 30 days (EFS) or SAEs within 12 months (pivotal) following the cryoablation procedure.	1 month post cryoablation procedure	Events will be adjudicated by an independent Clinical Events Committee (CEC).
Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds	6-month post cryoablation procedure	Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months (EFS) or 12 months (pivotal).
Health Outcomes for EFS and Pivotal phases are defined as cardiac mortality at 12 months	12-months post cryoablation procedure	Cardiac mortality at 12 months
Health Outcomes for EFS and Pivotal phases are defined as quality-of-life improvement as measured by reduction of VT burden at 6 and 12 months compared to baseline.	6 and 12-months post cryoablation procedure	Reduction in the number of ICD shocks and number of VT related hospitalizations
Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from inducible MMVT <30s	6-month post cryoablation procedure	Freedom from inducible MMVT with a cycle length similar to (within 30 ms) or slower than the targeted VT and lasting longer than 30 seconds at the end of the ablation procedure.
Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds without AAD	6-month post cryoablation procedure	Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months in the absence of new AADs or increase in dose of pre-ablation AADs. Drug changes related specifically to management of atrial arrhythmias will not be included in the analysis of this endpoint (EFS

Trial Locations

Locations (15)

Banner University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Weill Cornell Medical Center; 🇺🇸 New York, New York, United States

Northwell Health- Staten Island University Hospital; 🇺🇸 Staten Island, New York, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Hospital of University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Medical Center of South Carolina (MUSC); 🇺🇸 Charleston, South Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Research Institute (TCARF); 🇺🇸 Austin, Texas, United States

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

McGill University; 🇨🇦 Montreal, Quebec, Canada