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 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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
Onze Lieve Vrouwziekenhuis
Aalst, Belgium
McGill University Health Centre
Montreal, Canada
Montreal Hear Institute
Montreal, Canada
Nemocnice na Homolce
Prague, Czechia
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
Time frame: 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.
Time frame: 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
Time frame: at the end of the cryoablation procedure
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.
Time frame: 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
Time frame: 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)
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CHU-Bordeaux, Pôle cardio-thoracique, Hôpital Haut-Lévêque
Bordeaux, France
Herzzentrum Leipzig Universitätsklinik für Kardiologie
Leipzig, Germany
St Antonius Ziekenhuis
Nieuwegein, Netherlands
Time frame: 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)
Time frame: 12 months post cryoablation procedure
Performance - VT burden
Reduction of VT burden at 6 and 12 months
Time frame: 6 and 12 months post cryoablation procedure
Descriptive Statistical Outcome - fluoroscopy time
Procedure fluoroscopy time
Time frame: at the end of the cryoablation procedure
Descriptive Statistical Outcome - ablation time
Total ablation time
Time frame: at the end of the cryoablation procedure
Descriptive Statistical Outcome - procedure time
Total ablation time
Time frame: at the end of the cryoablation procedure
Descriptive Statistical Outcome - cryoablation lesions
Number and location of cryoablation lesions
Time frame: at the end of the cryoablation procedure
Descriptive Statistical Outcome - inducible VTs
Number of inducible clinical VTs before and after cryoablation
Time frame: 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
Time frame: 12 months post cryoablation procedure
Descriptive Statistical Outcome - ablation strategies
Mapping and ablation strategies utilized during the ablation procedure
Time frame: at the end of the cryoablation procedure
Descriptive Statistical Outcome - Hospitalization
Freedom from cardiovascular (CV) hospitalizations or CV-related ER visits through 12 months
Time frame: 12 months post cryoablation procedure
Descriptive Statistical Outcome - AADs use
Recording of the use of AADs in the follow up period
Time frame: 12 months post cryoablation procedure