Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)

Who can take part

• 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

Who cannot take part

• 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
• Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to the procedure
• Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
• 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)
• 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 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
• Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
• Cardiac myxoma
• EC 2 Any duration of continuous arrythmia that is not monomorphic ventricular tachycardia. Multiple monomorphic tachycardia is acceptable, but polymorphic VT is not
• Aortic aneurysm
• Interatrial baffle, closure device, patch, or PFO occlusion device
• IVC filter
• Significant congenital anomaly