Cryoablation treatment for sustained ventricular tachycardia

Cryoablation for Monomorphic Ventricular Tachycardia IDE Study: EFS and Pivotal

This study is testing a new cryoablation treatment to see if it can safely help people with recurrent ventricular tachycardia who already have an implantable defibrillator.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 206 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Adagio Medical (Industry-sponsored)
• Locations: 15 sites (Phoenix, Arizona and 14 other locations)
• Trial ID: NCT05675865 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and effectiveness of the Adagio VT Cryoablation System for treating sustained monomorphic ventricular tachycardia (SMVT). It is a prospective, single-arm, multi-center, open-label study that includes patients with recurrent SMVT who are scheduled for endocardial VT ablation. Participants must have an Implantable Cardioverter Defibrillator (ICD) prior to the procedure. The study consists of an early feasibility phase and a pivotal study phase to gather data for future marketing applications.

Who should consider this trial

Good fit: Ideal candidates include adults with recurrent symptomatic sustained scar-mediated monomorphic ventricular tachycardia and an ICD.

Not a fit: Patients without a history of recurrent SMVT or those who do not have an ICD may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of patients with recurrent sustained monomorphic ventricular tachycardia.

How similar studies have performed: Other studies have shown promising results with cryoablation techniques for similar conditions, indicating potential for success in this approach.

Eligibility criteria

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 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):

* EC 1 Intracardiac thrombus by TTE or TEE within 48 hours prior to the procedure
* 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)

Where this trial is running

Phoenix, Arizona and 14 other locations

• Banner University Medical Center Phoenix — Phoenix, Arizona, United States (Recruiting)
• University of California San Francisco — San Francisco, California, United States (Recruiting)
• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
• Weill Cornell Medical Center — New York, New York, United States (Recruiting)
• Northwell Health- Staten Island University Hospital — Staten Island, New York, United States (Recruiting)
• Ohio State University — Columbus, Ohio, United States (Recruiting)
• Hospital of University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
• Medical Center of South Carolina (MUSC) — Charleston, South Carolina, United States (Recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
• Texas Cardiac Arrhythmia Research Institute (TCARF) — Austin, Texas, United States (Recruiting)
• Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
• McGill University — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Nabil Jubran

Conditions Sustained VT; cryoablation; monomorphic VT; sustained monomorphic VT