Clinical trial NCT04893317: Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)
Official title: Cryoablation for Monomorphic Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Monomorphic Ventricular Tachycardia
Lead sponsor: Adagio Medical
Sponsor class: INDUSTRY
First posted: 2021-05-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Primary Endpoint for Safety
timeFrame: during and 30 days post cryoablation procedure
measure: Primary Endpoint for Clinical Performance
timeFrame: 6 month post cryoablation procedure
measure: Primary Endpoint for Procedure Performance
timeFrame: at the end of the cryoablation procedure
Secondary outcomes:
measure: Safety - freedom from procedure or device related SAE
timeFrame: 12 months post cryoablation procedure
measure: Performance - non-inducible sustained monomorphic VT
timeFrame: at the end of the cryoablation procedure
measure: Performance - freedom from VT at 12-M off AADs
timeFrame: 12 months post cryoablation procedure
measure: Performance - freedom from VT at 12-M on previously failed AADs
timeFrame: 12 months post cryoablation procedure
measure: Performance - VT burden
timeFrame: 6 and 12 months post cryoablation procedure
measure: Descriptive Statistical Outcome - fluoroscopy time
timeFrame: at the end of the cryoablation procedure
measure: Descriptive Statistical Outcome - ablation time
timeFrame: at the end of the cryoablation procedure
measure: Descriptive Statistical Outcome - procedure time
timeFrame: at the end of the cryoablation procedure
measure: Descriptive Statistical Outcome - cryoablation lesions
timeFrame: at the end of the cryoablation procedure
measure: Descriptive Statistical Outcome - inducible VTs
timeFrame: at the end of the cryoablation procedure
measure: Descriptive Statistical Outcome - ICD shocks
timeFrame: 12 months post cryoablation procedure
measure: Descriptive Statistical Outcome - ablation strategies
timeFrame: at the end of the cryoablation procedure
measure: Descriptive Statistical Outcome - Hospitalization
timeFrame: 12 months post cryoablation procedure
measure: Descriptive Statistical Outcome - AADs use
timeFrame: 12 months post cryoablation procedure
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouwziekenhuis
city: Montréal
country: Canada
facility: McGill University Health Centre
city: Montréal
country: Canada
facility: Montreal Hear Institute
city: Prague
country: Czechia
facility: Nemocnice na Homolce
city: Bordeaux
country: France
facility: CHU-Bordeaux, Pôle cardio-thoracique, Hôpital Haut-Lévêque
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig Universitätsklinik für Kardiologie
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
Study officials:
References: