Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS)

Study Overview
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Brief Summary
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The objective of this clinical study is to evaluate the safety and performance of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic VT (SMVT)

Detailed Description
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A prospective, single-arm, multi-center, open label, pre-market, early feasibility clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of SMVT. 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.

Official Title
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Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS)

Conditions
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Sustained VT

Intervention / Treatment
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* Device: cryoablation procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (IC): IC 1 Male or female ≥ 18 years IC 2 Patients with a clinical indication for a catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained monomorphic Ventricular Tachycardia IC 3 Has received an ICD prior to enrollment IC 4 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months IC 5 Refractory to, or intolerant of, at least one Class III AAD IC 6 Subject has LVEF ≥ 20%, confirmed by echo or comparable technique during baseline evaluation or in the previous three months 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 Idiopathic VT EC 3 Any VT ablation within 4 weeks prior to enrollment EC 4 More than one prior (>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause EC 6 Cardiogenic shock, unless it is due to incessant monomorphic VT EC 7 Structural heart disease as described below: Class IV heart failure Aortic aneurysm Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to index procedure Interatrial baffle, closure device, patch, or PFO occlusion device Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure Acute MI or unstable angina in the previous 60 days Mechanical mitral or aortic valve Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE Cardiac myxoma Significant congenital heart disease EC 8 Acute illness or active systemic infection EC 9 Any previous history of cryoglobulinemia EC 10 History of blood clotting or bleeding disease EC 11 Peripheral vascular disease that precludes LV access EC 12 Contraindication to heparin EC 13 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure EC 14 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 15 Pregnant, or anticipated pregnancy during study follow-up EC 16 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 17 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: VT Cryoablation<br>all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for MVT | Device: cryoablation procedure<br>* ablation procedure for VT using the investigational device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint for Safety - Analysis of the proportion of subjects with freedom from definite or probable device/procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation procedure. | Events will be adjudicated by an independent Clinical Events Committee (CEC). MAEs include any of the following: Death Acute myocardial infarction Cardiac perforation/pericardial tamponade Cerebral infarct or systemic embolism Major bleeding requiring transfusion Acute Mitral, Tricuspid or Aortic valve damage resulting in moderate or severe regurgitation Access site complications requiring medical or surgical intervention Pericarditis Heart block requiring a permanent pacemaker Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) to be probably or definitely related to the Adagio System. | 7 days following the ablation procedure | 
| Primary Procedural Endpoint - 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. | Documentation of VT non-inducibility or no further ablation targets meeting the criteria for ablation at the end of the cryoablation procedure. | During Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Endpoint - Analysis of the proportion of subjects with freedom from definite or probable device/procedure related Major Adverse Events (MAEs) that occur within 30 days following the cryoablation procedure. | Events will be adjudicated by an independent Clinical Events Committee (CEC). | 1 month post cryoablation procedure | 
| Secondary Efficacy Endpoint - Analysis of the proportion of subjects with freedom from inducible MMVT <30s | Freedom from inducible MMVT with a cycle length similar to (within 30 ms) or slower than the targeted VT and lasting longer than 30 seconds at the end of the ablation procedure | 6-month post cryoablation procedure | 
| Secondary Efficacy Endpoint - Analysis of the proportion of subjects with freedom from VT > 30 seconds | Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months. | 6-month post cryoablation procedure | 
| Secondary Efficacy Endpoint - Analysis of the proportion of subjects with freedom from VT > 30 seconds without AAD | Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months in the absence of new AADs or increase in dose of pre-ablation AADs | 6-month post cryoablation procedure | 
| Secondary Efficacy Endpoint - VT burden | Reduction of VT burden at 6 months | 6-month post cryoablation procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryoablation, monomorphic VT, sustained monomorphic VT