Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS) (FULCRUM-VT)
Sustained VT
About this trial
This is an interventional treatment trial for Sustained VT focused on measuring cryoablation, monomorphic VT, sustained monomorphic VT
Eligibility Criteria
Inclusion Criteria (IC): IC 1 Male or female ≥ 18 years IC 2 Patients with a clinical indication for a catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained monomorphic Ventricular Tachycardia IC 3 Has received an ICD prior to enrollment IC 4 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months IC 5 Refractory to, or intolerant of, at least one Class III AAD IC 6 Subject has LVEF ≥ 20%, confirmed by echo or comparable technique during baseline evaluation or in the previous three months IC 7 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study IC 8 Willingness and ability to give an informed consent Exclusion Criteria (EC): EC 1 Intracardiac thrombus by TTE or TEE within 48 hours prior to the procedure EC 2 Idiopathic VT EC 3 Any VT ablation within 4 weeks prior to enrollment EC 4 More than one prior (>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause EC 6 Cardiogenic shock, unless it is due to incessant monomorphic VT EC 7 Structural heart disease as described below: Class IV heart failure Aortic aneurysm Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to index procedure Interatrial baffle, closure device, patch, or PFO occlusion device Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure Acute MI or unstable angina in the previous 60 days Mechanical mitral or aortic valve Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE Cardiac myxoma Significant congenital heart disease EC 8 Acute illness or active systemic infection EC 9 Any previous history of cryoglobulinemia EC 10 History of blood clotting or bleeding disease EC 11 Peripheral vascular disease that precludes LV access EC 12 Contraindication to heparin EC 13 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure EC 14 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 15 Pregnant, or anticipated pregnancy during study follow-up EC 16 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 17 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
- Banner University Medical Center PhoenixRecruiting
- University of California San FranciscoRecruiting
- Icahn School of Medicine at Mount SinaiRecruiting
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Experimental
VT Cryoablation
all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for MVT