Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT) (CryoCure-VT)

Cryoablation for Monomorphic Ventricular Tachycardia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Monomorphic Ventricular Tachycardia
• Intervention / Treatment: Device: Ablation in the ventricles with the Adagio Medical VT Cryoablation System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Didier BILLY, PhD; Phone Number: +31654954128; Email: dbilly@adagiomedical.com
• Study Contact Backup: Name: Nabil JUBRAN; Phone Number: 207 +1 949-348-1188; Email: njubran@adagiomedical.com

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Onze Lieve Vrouwziekenhuis
• Canada
  • Montréal, Canada
    • McGill University Health Centre
  • Montréal, Canada
    • Montreal Hear Institute
• Czechia
  • Prague, Czechia
    • Nemocnice Na Homolce
• France
  • Bordeaux, France
    • CHU-Bordeaux, Pôle cardio-thoracique, Hôpital Haut-Lévêque
• Germany
  • Leipzig, Germany
    • Herzzentrum Leipzig Universitätsklinik für Kardiologie
• Netherlands
  • Nieuwegein, Netherlands
    • St Antonius Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

1. Class IV heart failure
2. Aortic aneurysm
3. Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to the procedure
4. Interatrial baffle, closure device, patch, or PFO occlusion device
5. IVC filter
6. Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
7. Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
8. Cardiac myxoma
9. Significant congenital anomaly
10. Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to the ablation procedure
11. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ablation in the ventricle with the Adagio VT cryoablation system; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Adagio Medical

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: CS-098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No