Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)

NCT04893317 | Completed DMC

• 1 other identifier: CS-098
• Study Type: interventional
• Target: 64
• Locations: 6 countries
• Sites: 7

Brief Summary

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.

Conditions

Monomorphic Ventricular Tachycardia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• Safety - freedom from procedure or device related SAE

  12 months post cryoablation procedure

• Performance - non-inducible sustained monomorphic VT

  at the end of the cryoablation procedure

• Performance - freedom from VT at 12-M off AADs

  12 months post cryoablation procedure

• Performance - freedom from VT at 12-M on previously failed AADs

  12 months post cryoablation procedure

• Performance - VT burden

  6 and 12 months post cryoablation procedure

Study Arms (1)

Ablation in the ventricle with the Adagio VT cryoablation system

EXPERIMENTAL

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

Interventions

Ablation in the ventricles with the Adagio Medical VT Cryoablation System DEVICE

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

Ablation in the ventricle with the Adagio VT cryoablation system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adagio Medical: lead

Study Sites (7)

Onze Lieve Vrouwziekenhuis

Aalst, Aalst, 9300, Belgium

Location

McGill University Health Centre

Montreal, Canada

Location

Montreal Hear Institute

Montreal, Canada

Location

Nemocnice na Homolce

Prague, Czechia

Location

CHU-Bordeaux, Pôle cardio-thoracique, Hôpital Haut-Lévêque

Bordeaux, France

Location

Herzzentrum Leipzig Universitätsklinik für Kardiologie

Leipzig, Germany

Location

St Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Related Publications (2)

• Verma A, Essebag V, Neuzil P, Dyrda K, Balt J, Dinov B, Darma A, Arya A, Sacher F, Reddy VY, Boersma L, Grigorov I, De Potter T. Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies. Europace. 2024 Mar 30;26(4):euae076. doi: 10.1093/europace/euae076.

  PMID: 38582974 DERIVED

• De Potter T, Balt JC, Boersma L, Sacher F, Neuzil P, Reddy V, Grigorov I, Verma A. First-in-Human Experience With Ultra-Low Temperature Cryoablation for Monomorphic Ventricular Tachycardia. JACC Clin Electrophysiol. 2023 May;9(5):686-691. doi: 10.1016/j.jacep.2022.11.017. Epub 2023 Jan 18.

  PMID: 36752466 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 19, 2021
• Study Start: May 26, 2021
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); BE (1); DE (1); FR (1); NL (1); CA (2)