Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)

Study Overview
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Brief Summary
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A prospective, single-arm, multi-center, pre-market, clinical study designed to provide safety and performance data regarding the use of the Adagio Medical VT Cryoablation System in the treatment of ventricular tachycardia.

Detailed Description
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Study subjects will include patients who experience recurrent monomorphic VT and are scheduled for an endocardial VT ablation. Study subjects have or will have an Implantable Cardioverter Defibrillator (ICD) prior to hospital discharge following the cryoablation procedure. A VT ablation procedure is performed by finding the abnormal ventricular heart tissue that is causing the VT and applying energy with an ablation catheter to the area. The goal is to apply energy to create a scar or destroy the tissue that causes the VT, such that VT is no longer present or inducible.

Official Title
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Cryoablation for Monomorphic Ventricular Tachycardia

Conditions
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Monomorphic Ventricular Tachycardia

Intervention / Treatment
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* Device: Ablation in the ventricles with the Adagio Medical VT Cryoablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IC 1 Male or female the ages of ≥ 18 years IC 2 Eligible for a catheter ablation due to Ischemic and/or non-ischemic recurrent symptomatic sustained monomorphic Ventricular Tachycardia also defined as having a similar QRS configuration from beat to beat. IC 3 Has or will be receiving an ICD prior to hospital discharge post procedure. IC 4 Refractory to at least one AAD (Refractory is defined as an AAD not able to treat the arrhythmia satisfactorily or induces unwanted side effects). IC 5 Subject has LVEF > 20%, confirmed by echo or comparable technique in the previous 3 months or during baseline evaluation IC 6 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study IC 7 Willingness and ability to give an informed consent Exclusion Criteria: EC 1 Any known objective contraindication to ventricular tachycardia ablation, TEE, or anticoagulation, including but not limited to the identification of any cardiac thrombus or evidence of sepsis EC 2 Any duration of continuous arrythmia that is not monomorphic ventricular tachycardia. Multiple monomorphic tachycardia is acceptable, but polymorphic VT is not. EC 3 Any VT ablation within 4 weeks prior to enrollment EC 4 More than one prior (>4 weeks) Ventricular Tachycardia ablation or prior surgical treatment for ventricular tachycardia EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause EC 6 Structural heart disease as described below: Class IV heart failure Aortic aneurysm Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to the procedure Interatrial baffle, closure device, patch, or PFO occlusion device IVC filter Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE Cardiac myxoma Significant congenital anomaly Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to the ablation procedure Mechanical aortic or mitral valve EC 7 Any previous history of cryoglobulinemia EC 8 History of blood clotting or bleeding disease EC 9 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 10 Breastfeeding, pregnant, or anticipated pregnancy during study follow-up EC 11 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 12 Any other condition 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ablation in the ventricle with the Adagio VT cryoablation system<br>all study subjects will receive an ablation procedure using the Adagio Medical VT Cryoablation System | Device: Ablation in the ventricles with the Adagio Medical VT Cryoablation System<br>* The Adagio Medical VT Cryoablation System is indicated for the treatment of monomorphic ventricular tachycardia by ablation of arrhythmogenic tissue that drives and maintains these arrhythmias<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint for Safety | An analysis of the proportion of subjects who are free from definite or probable device/procedure related Major Adverse Events (MAEs) that occur during or within 30 days following the cryoablation procedure | during and 30 days post cryoablation procedure | 
| Primary Endpoint for Clinical Performance | an analysis of the proportion of patients receiving a single cryoablation procedure with freedom from ventricular tachycardia lasting longer than 30 seconds or appropriate ICD intervention until the end of the 6 month follow up period. | 6 month post cryoablation procedure | 
| Primary Endpoint for Procedure Performance | an analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryoablation procedure | at the end of the cryoablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - freedom from procedure or device related SAE | The proportion of study subjects with probable or definite device or procedure related serious adverse events (SAEs) including MAEs as described above, or serious adverse device effects (SADEs) between 30-days up to 12 months post-procedure. | 12 months post cryoablation procedure | 
| Performance - non-inducible sustained monomorphic VT | The proportion of study subjects with non-inducible sustained monomorphic VT at the end of the ablation procedure | at the end of the cryoablation procedure | 
| Performance - freedom from VT at 12-M off AADs | The proportion of study subjects with freedom from Ventricular Tachycardia lasting longer than 30 seconds at 12 months without the use of anti-arrhythmic drugs (AADs) | 12 months post cryoablation procedure | 
| Performance - freedom from VT at 12-M on previously failed AADs | The proportion of study subjects with freedom from Ventricular Tachycardia lasting longer than 30 seconds at 12 months with previously failed anti-arrhythmic drugs (AADs) | 12 months post cryoablation procedure | 
| Performance - VT burden | Reduction of VT burden at 6 and 12 months | 6 and 12 months post cryoablation procedure | 
| Descriptive Statistical Outcome - fluoroscopy time | Procedure fluoroscopy time | at the end of the cryoablation procedure | 
| Descriptive Statistical Outcome - ablation time | Total ablation time | at the end of the cryoablation procedure | 
| Descriptive Statistical Outcome - procedure time | Total ablation time | at the end of the cryoablation procedure | 
| Descriptive Statistical Outcome - cryoablation lesions | Number and location of cryoablation lesions | at the end of the cryoablation procedure | 
| Descriptive Statistical Outcome - inducible VTs | Number of inducible clinical VTs before and after cryoablation | at the end of the cryoablation procedure | 
| Descriptive Statistical Outcome - ICD shocks | Number of appropriate and inappropriate ICD therapies (shocks and pacing) in the follow up period | 12 months post cryoablation procedure | 
| Descriptive Statistical Outcome - ablation strategies | Mapping and ablation strategies utilized during the ablation procedure | at the end of the cryoablation procedure | 
| Descriptive Statistical Outcome - Hospitalization | Freedom from cardiovascular (CV) hospitalizations or CV-related ER visits through 12 months | 12 months post cryoablation procedure | 
| Descriptive Statistical Outcome - AADs use | Recording of the use of AADs in the follow up period | 12 months post cryoablation procedure |