Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
206 participants
INTERVENTIONAL
2023-09-11
2026-03-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VT Cryoablation
all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for SMVT
cryoablation procedure
ablation procedure for VT using the investigational device
Interventions
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cryoablation procedure
ablation procedure for VT using the investigational device
Eligibility Criteria
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Inclusion Criteria
* 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 scar in a territory without coronary stenosis as evidenced by CMR imaging within the prior 90 days or intra-procedurally using EAM and PES prior to investigational device use, 20% ≤ LVEF \< 50%
* Arrhythmogenic right ventricular cardiomyopathy (ARVC)
* IC 4 Has received a market-released ICD prior to enrollment
* IC 5 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months
* IC 6 Refractory to, or intolerant of, at least one Class III AAD. (Refractory or intolerant defined as AAD failure due to recurrent VT, not tolerated/ desired due to side effects)
* IC 7 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study
* IC 8 Willingness and ability to give an informed consent
Exclusion Criteria
* EC 2 Presence of isolated epicardial scar(s) requiring epicardial ablation identified by either preoperative CMR imaging within 90 days of procedure or intra-procedurally using EAM and PES prior to investigational device use
* EC 3 VTs due to any of the following causes:
1. Idiopathic VT
2. Automaticity or triggered activity
3. Bundle Branch Reentry (BBR)
4. Any focal tachycardia (e.g., papillary, RVOT)
5. Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
* EC 4 NICM patients only, if any of the following apply:
1. Congenital condition that limits access to the left or right ventricles
2. Severe aortic or mitral stenosis, severe mitral regurgitation, or severe aortic insufficiency
3. Active inflammatory processes (e.g., myocarditis) within the past 120 days
4. Sarcoidosis
5. Hypertrophic cardiomyopathy
6. Drug- or alcohol-induced cardiomyopathy
* EC 5 Any VT ablation within 4 weeks prior to enrollment
* EC 6 More than one prior (\>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years
* EC 7 Cardiogenic shock, unless it is due to incessant monomorphic VT
* EC 8 Any other cardiovascular conditions as described below:
1. Class IV heart failure
2. Aortic aneurysm
3. Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to index procedure
4. Interatrial baffle, closure device, patch, or PFO occlusion device
5. Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
6. Acute MI or unstable angina in the previous 60 days
7. Mechanical mitral or aortic valve
8. Cardiac myxoma
9. Significant congenital heart disease
* EC 9 Acute illness or active systemic infection
* EC 10 Any previous history of cryoglobulinemia
* EC 11 History of blood clotting or bleeding disease
* EC 12 Peripheral vascular disease that precludes LV access
* EC 13 Contraindication to heparin
* EC 14 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure
* EC 15 Any prior history of documented cerebral vascular accident (CVA), TIA or systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT), within 6 months prior to the ablation procedure.
* EC 16 Pregnant, or anticipated pregnancy during study follow-up
* EC 17 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study
* EC 18 Any other condition (e.g., ARVC with extensive free wall scarring) that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, candidate for heart transplantation, patient with ventricular assist device, or terminal illness with a life expectancy less than 12 months)
18 Years
ALL
No
Sponsors
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Adagio Medical
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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CS-300
Identifier Type: -
Identifier Source: org_study_id
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