The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System 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. This IDE study includes two phases, an early feasibility (EFS) phase to support initial device safety and effectiveness, and a Pivotal Study phase to collect safety and effectiveness data for a future PMA marketing application.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
206
ablation procedure for VT using the investigational device
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
RECRUITINGUniversity of California San Francisco
Primary Safety Endpoint for EFS and Pivotal phases is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation 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 Procedural Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with non-inducible VT or no further ablation targets meeting the criteria for ablation at the end of the cryoablation procedure.
Documentation of non-inducibility of any VT targeted for ablation at the end of procedure.
Time frame: During Procedure
Primary Efficacy Endpoint for Pivotal Phase
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
Secondary Safety Endpoint - Analysis of the proportion of subjects with freedom from definite or probable device or procedure related MAEs that occur within 30 days (EFS) or SAEs within 12 months (pivotal) following the cryoablation procedure.
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San Francisco, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGWeill Cornell Medical Center
New York, New York, United States
RECRUITINGNorthwell Health- Staten Island University Hospital
Staten Island, New York, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGHospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITING...and 5 more locations
Events will be adjudicated by an independent Clinical Events Committee (CEC).
Time frame: 1 month post cryoablation procedure
Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from inducible MMVT <30s
Freedom from inducible MMVT with a cycle length similar to (within 30 ms) or slower than the targeted VT and lasting longer than 30 seconds at the end of the ablation procedure.
Time frame: 6-month post cryoablation procedure
Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds
Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months (EFS) or 12 months (pivotal).
Time frame: 6-month post cryoablation procedure
Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds without AAD
Freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 6 months in the absence of new AADs or increase in dose of pre-ablation AADs. Drug changes related specifically to management of atrial arrhythmias will not be included in the analysis of this endpoint (EFS
Time frame: 6-month post cryoablation procedure
Health Outcomes for EFS and Pivotal phases are defined as all-cause mortality at 12 months
All-cause mortality at 12 months
Time frame: 12-months post cryoablation procedure
Health Outcomes for EFS and Pivotal phases are defined as cardiac mortality at 12 months
Cardiac mortality at 12 months
Time frame: 12-months post cryoablation procedure
Health Outcomes for EFS and Pivotal phases are defined as quality-of-life improvement as measured by reduction of VT burden at 6 and 12 months compared to baseline.
Reduction in the number of ICD shocks and number of VT related hospitalizations
Time frame: 6 and 12-months post cryoablation procedure