Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cryoablation for Monomorphic Ventricular Tachycardia

NCT05675865

Sustained VT

RECRUITING NA

Computational Cardiac Imaging Analysis to Guide Ventricular Tachycardia Ablation Procedures (AI-VT)

NCT06964152

Ventricular Tachycardia (VT) Premature Ventricular Contraction (PVC) Ventricular Fibrillation

ENROLLING_BY_INVITATION NA

Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia

NCT04642963

Ventricular Tachycardia

COMPLETED NA

Functional Substrate-Only Guided VT Ablation

NCT06464315

Ventricular Tachycardia Sudden Cardiac Death

NOT_YET_RECRUITING NA

Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation

NCT07201506

Ablation of Arrhythmias Premature Ventricular Contractions Ventricular Tachycardia +1 more

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Monomorphic Ventricular Tachycardia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Ablation in the ventricles with the Adagio Medical VT Cryoablation System

Intervention Type DEVICE

The Adagio Medical VT Cryoablation System is indicated for the treatment of monomorphic ventricular tachycardia by ablation of arrhythmogenic tissue that drives and maintains these arrhythmias

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ablation in the ventricles with the Adagio Medical VT Cryoablation System

The Adagio Medical VT Cryoablation System is indicated for the treatment of monomorphic ventricular tachycardia by ablation of arrhythmogenic tissue that drives and maintains these arrhythmias

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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:

1. Class IV heart failure
2. Aortic aneurysm
3. Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to the procedure
4. Interatrial baffle, closure device, patch, or PFO occlusion device
5. IVC filter
6. Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
7. Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
8. Cardiac myxoma
9. Significant congenital anomaly
10. Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to the ablation procedure
11. 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No