Cryoablation for Monomorphic Ventricular Tachycardia (CryoCureVT)

  • STATUS
    Recruiting
  • End date
    Oct 15, 2023
  • participants needed
    40
  • sponsor
    Adagio Medical
Updated on 15 June 2022

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.

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.

Details
Condition Monomorphic Ventricular Tachycardia
Treatment Ablation in the ventricles with cryoablation, Ablation in the ventricles with the Adagio Medical VT Cryoablation System
Clinical Study IdentifierNCT04893317
SponsorAdagio Medical
Last Modified on15 June 2022

Eligibility

Yes No Not Sure

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
Aortic aneurysm
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
Interatrial baffle, closure device, patch, or PFO occlusion device
Multiple monomorphic tachycardia is acceptable, but polymorphic VT is not
IVC filter
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
Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
treatment for ventricular tachycardia
Cardiac myxoma
EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or
any other reversible or non-cardiac cause
Significant congenital anomaly
EC 6 Structural heart disease as described below
Class IV heart failure
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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