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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.
Full 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.
Enrollment
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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:
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 purpose
Allocation
Interventional model
Masking
64 participants in 1 patient group
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Central trial contact
Nabil JUBRAN; Didier BILLY, PhD
Data sourced from clinicaltrials.gov
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