The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio Medical vCLAS Ventricular Ablation System (including VTS Catheter and Console) in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)
A prospective, single-arm, multi-center, open label, pre-market, clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of scar-mediated SMVT in ischemic and non-ischemic patients. Study subjects will include patients who experience recurrent SMVT and are scheduled for an endocardial VT ablation. Study subjects must have an Implantable Cardioverter Defibrillator (ICD) prior to the cryoablation procedure. The VTS study is being initiated to collect safety and effectiveness data and support future PMA supplement marketing application.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
ablation procedure using the investigational device (vCLAS Ventricular Ablation System including VTS Catheter and Console)
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
RECRUITINGMemorialCare Long Beach Medical Center
Long Beach, California, United States
RECRUITINGPrimary Safety Endpoint - Freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure.
Primary Safety Endpoint is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure. Events will be adjudicated by an independent Clinical Events Committee (CEC). MAEs include any of the following: • Death • Acute myocardial infarction • Cardiac perforation/pericardial tamponade • Cerebral infarct or systemic embolism • Major bleeding requiring transfusion • Acute Mitral, Tricuspid or Aortic valve damage resulting in moderate or severe regurgitation • Access site complications requiring medical or surgical intervention • Pericarditis • Heart block requiring a permanent pacemaker • Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) to be probably or definitely related to the Adagio System.
Time frame: 7 days following the ablation procedure
Primary Efficacy Endpoint - Freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure
Primary Efficacy Endpoint is defined as freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure, where sustained MMVT is defined as continuous MMVT for \> 30 seconds (programmed monitoring zone only), or MMVT requiring appropriate ICD intervention regardless of duration. All ICD interrogation reports will be adjudicated by an independent VT Event Committee (VTEC) to support the primary efficacy endpoint.
Time frame: 6 months after the procedure
Primary Procedural Endpoint - Percentage of non-inducibility VT targeted for ablation post-procedure
Primary Procedural Endpoint is defined as non-inducibility of any VT targeted for ablation at the end of the procedure
Time frame: at the end of the ablation procedure
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Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGNorthwell Health- Staten Island University Hospital
Staten Island, New York, United States
RECRUITINGHospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGMedical Center of South Carolina (MUSC)
Charleston, South Carolina, United States
RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGVirginia Commonwealth University
Richmond, Virginia, United States
RECRUITINGMcGill University Health Centre (MUHC), Montreal General Hospital (MGH)
Montreal, Quebec, Canada
RECRUITINGMontreal Hear Institute
Montreal, Canada
RECRUITINGSecondary Safety Endpoint - Freedom from definite or probable device or procedure related Serious Adverse Events (SAEs) within 12 months following the ablation procedure
Secondary Safety Endpoint is defined as freedom from definite or probable device or procedure related Serious Adverse Events (SAEs) within 12 months following the ablation procedure. Events will be adjudicated by an independent Clinical Events Committee (CEC).
Time frame: 12-months post ablation procedure
Secondary Efficacy Endpoint - Freedom from VT greater than 30 seconds or appropriate ICD intervention at 12 months
Secondary Efficacy Endpoint is defined as freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 12 months
Time frame: 12-months post ablation procedure