iCLAS™ for Persistent Atrial Fibrillation
- Conditions
- Persistent Atrial Fibrillation
- Interventions
- Device: Adagio AF Cryoablation System (iCLAS™)
- Registration Number
- NCT04061603
- Lead Sponsor
- Adagio Medical
- Brief Summary
Clinical study to evaluate the safety and efficacy of the Adagio AF Cryoablation System (iCLAS™) in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF). Data will be used to support a pre-market application (PMA)
- Detailed Description
A staged pre-market, single-arm, clinical study designed to collect acute and long-term safety and efficacy data for the Adagio AF Cryoablation System (iCLAS™). Patient population will consist of symptomatic, persistent AF subjects completing a de novo ablation procedure. Enrollment will be 200 subjects at up to 20 global investigational sites. Subjects will receive an ablation with the ultra-low cryoablation device. Follow-up will include assessment at one, three, six, and twelve months.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description iCLAS Ablation Adagio AF Cryoablation System (iCLAS™) Ablation of the left and right atrium with the Adagio Medical iCLAS System
- Primary Outcome Measures
Name Time Method Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure. 12-months MAEs include any of the following:
* Death
* Myocardial infarction
* Cardiac perforation/pericardial tamponade
* Cerebral infarct or systemic embolism
* Major bleeding requiring transfusion of blood products
* Mitral or tricuspid valve damage
* Symptomatic pulmonary vein stenosis
* Severe (≥ 70%) pulmonary vein stenosis
* Permanent phrenic nerve injury
* Access site complications requiring pharmacological or surgical intervention
* Atrio-esophageal fistula
* Pericarditis
* Heart block requiring a permanent pacemaker
* Vagal nerve injury with GI dysmotility
* Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) as "probably or definitely related" to the Adagio SystemAnalysis of the proportion of subjects receiving a single cryoablation who are free from any documented left atrial arrhythmia (AF/AFL/AT). 12-months The primary effectiveness endpoint will be based on a centralized core lab interpretation of the recordings used in the endpoint analysis.
- Secondary Outcome Measures
Name Time Method Recording and analysis of all identified SAEs and SADEs through 12-months post-procedure. 12-months Events will be sub-stratified based on time to event as follows:
* Early onset (procedure through 7-days post-ablation)
* Peri-procedure (\> 7-days through 30-days post-ablation)
* Late onset (\>30-days post ablation)Analysis of the proportion of subjects with acute procedural (ablation) success 20-minutes following last ablation Documentation of pulmonary vein isolation and posterior wall isolation
Trial Locations
- Locations (21)
Southlake Regional Medical Centre
🇨🇦Newmarket, Ontario, Canada
Emory St. Joseph's Hospital
🇺🇸Atlanta, Georgia, United States
St. Bernards Medical Center
🇺🇸Jonesboro, Arkansas, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Prairie Heart Research Institute
🇺🇸Springfield, Illinois, United States
Staten Island University Hospital - Northwell Health
🇺🇸Staten Island, New York, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
New Mexico Heart Institute
🇺🇸Albuquerque, New Mexico, United States
Onze Lieve Vrouwziekenhuis
🇧🇪Aalst, Belgium
ZNA Middelheim
🇧🇪Antwerp, Belgium
St. Antonius Ziekenhuis Nieuwegein
🇳🇱Nieuwegein, Netherlands
Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
Banner Health
🇺🇸Phoenix, Arizona, United States
Baylor St. Luke's Medical Center
🇺🇸Houston, Texas, United States
University of California San Diego
🇺🇸San Diego, California, United States
South Denver Cardiology Associates
🇺🇸Denver, Colorado, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States