Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT) (CryoCure-VT)
Monomorphic Ventricular Tachycardia
About this trial
This is an interventional treatment trial for Monomorphic Ventricular Tachycardia
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:
- 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
- Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to the ablation procedure
- 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)
Sites / Locations
- Onze Lieve VrouwziekenhuisRecruiting
- McGill University Health CentreRecruiting
- Montreal Hear InstituteRecruiting
- Nemocnice na HomolceRecruiting
- CHU-Bordeaux, Pôle cardio-thoracique, Hôpital Haut-LévêqueRecruiting
- Herzzentrum Leipzig Universitätsklinik für KardiologieRecruiting
- St Antonius ZiekenhuisRecruiting
Arms of the Study
Arm 1
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