Actively Recruiting
Cryoablation for Monomorphic Ventricular Tachycardia
Led by Adagio Medical · Updated on 2026-04-07
206
Participants Needed
15
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Cryoablation for Monomorphic Ventricular Tachycardia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years or older
- Clinical indication for catheter ablation due to ischemic and/or non-ischemic heart disease with recurrent symptomatic sustained scar-mediated monomorphic ventricular tachycardia
- Diagnosis of ischemic cardiomyopathy with prior myocardial infarction and left ventricular ejection fraction between 20% and less than 50%
- Diagnosis of non-ischemic cardiomyopathy with scar in territory without coronary stenosis confirmed by imaging within 90 days or intra-procedurally, with left ventricular ejection fraction between 20% and less than 50%
- Diagnosis of arrhythmogenic right ventricular cardiomyopathy
- Received a market-released Implantable Cardioverter Defibrillator before enrollment
- At least one documented spontaneous episode of sustained monomorphic ventricular tachycardia within the previous 6 months
- Refractory or intolerant to at least one Class III antiarrhythmic drug
- Willingness and ability to participate in baseline and follow-up evaluations for the full length of the study
- Willingness and ability to give informed consent
You will not qualify if you...
- Presence of intracardiac thrombus within 48 hours prior to procedure
- Presence of isolated epicardial scar requiring epicardial ablation identified by imaging or intra-procedurally
- Ventricular tachycardias due to idiopathic causes, automaticity, bundle branch reentry, focal tachycardia, or secondary to electrolyte imbalance or reversible non-cardiac causes
- For non-ischemic cardiomyopathy patients: congenital conditions limiting ventricular access, severe valve diseases, active inflammatory processes within 120 days, sarcoidosis, hypertrophic cardiomyopathy, or drug/alcohol-induced cardiomyopathy
- Any ventricular tachycardia ablation within 4 weeks prior to enrollment
- More than one prior ventricular tachycardia ablation or surgical treatment within 2 years
- Cardiogenic shock unless due to incessant monomorphic ventricular tachycardia
- Severe cardiovascular conditions including Class IV heart failure, recent cardiac surgery or coronary intervention, cardiac devices or defects, recent acute myocardial infarction or unstable angina, mechanical heart valves, cardiac tumors, or significant congenital heart disease
- Acute illness or active systemic infection
- History of cryoglobulinemia
- History of blood clotting or bleeding disorders
- Peripheral vascular disease preventing left ventricular access
- Contraindication to heparin
- Allergy to radiographic contrast dye that cannot be managed prior to procedure
- History of stroke, transient ischemic attack, or systemic embolism within 6 months prior to procedure
- Pregnant or anticipating pregnancy during study follow-up
- Current enrollment in another study that may interfere with this study's procedures or outcomes
- Any condition making the patient a poor candidate for the procedure or study, including mental illness, addiction, end-stage illness with less than 12 months life expectancy, ventricular assist device, or candidacy for heart transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
7
Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
8
Northwell Health- Staten Island University Hospital
Staten Island, New York, United States, 10305
Actively Recruiting
9
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
10
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
11
Medical Center of South Carolina (MUSC)
Charleston, South Carolina, United States, 29403
Actively Recruiting
12
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
Texas Cardiac Arrhythmia Research Institute (TCARF)
Austin, Texas, United States, 78705
Actively Recruiting
14
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
15
McGill University
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
N
Nabil Jubran
CONTACT
D
Doug Kurschinski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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