Clinical trial NCT05675865: Cryoablation for Monomorphic Ventricular Tachycardia
Official title: Cryoablation for Monomorphic Ventricular Tachycardia IDE Study: EFS and Pivotal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sustained VT
Keywords: cryoablation
monomorphic VT
sustained monomorphic VT
Lead sponsor: Adagio Medical
Sponsor class: INDUSTRY
First posted: 2023-01-09
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: 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.
timeFrame: 7 days following the ablation procedure
measure: 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.
timeFrame: During Procedure
measure: Primary Efficacy Endpoint for Pivotal Phase
timeFrame: 6 months after the procedure
Secondary outcomes:
measure: 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.
timeFrame: 1 month post cryoablation procedure
measure: Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from inducible MMVT <30s
timeFrame: 6-month post cryoablation procedure
measure: Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds
timeFrame: 6-month post cryoablation procedure
measure: Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds without AAD
timeFrame: 6-month post cryoablation procedure
measure: Health Outcomes for EFS and Pivotal phases are defined as all-cause mortality at 12 months
timeFrame: 12-months post cryoablation procedure
measure: Health Outcomes for EFS and Pivotal phases are defined as cardiac mortality at 12 months
timeFrame: 12-months post cryoablation procedure
measure: 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.
timeFrame: 6 and 12-months post cryoablation procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Staten Island
country: United States
facility: Northwell Health- Staten Island University Hospital
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Center of South Carolina (MUSC)
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Institute (TCARF)
state: Texas
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
References: