iCLAS™ for Persistent Atrial Fibrillation

Completed · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

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)

Key facts

Study ID

NCT04061603

Run by

Adagio Medical

People needed

215

Starts

2019-12-09

Expected to finish

2024-08-30

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• IC1 Male or female between the ages of 18 and 80 years
• IC2 Currently scheduled for an ablation of symptomatic, PsAF defined as continuous AF that is sustained > 7-days and ≤ 12 months and documented by the following: a. Physician's note indicating continuous AF > 7 days and ≤ 12 months, AND b. One of the following: i. 24-hour Holter within 180 days of enrollment showing continuous AF, OR ii. Two electrocardiograms from any forms of rhythm monitoring (e.g., 12-lead ECGs or single lead ECGs) completed ≥ 7 days apart within 180 days of enrollment.
• IC3 Refractory to at least one class I or III AAD. (Refractory defined as not effective, not tolerated or not desired)
• IC4 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
• IC5 Willingness and ability to give an informed consent

You may not qualify if…

• EC 1 In the opinion of the Investigator, any known contraindication to an atrial ablation, TEE, or anticoagulation. Including, but not limited to, the identification of any atrial thrombus or evidence of sepsis
• EC 2 Any duration of continuous AF lasting longer than 12-months
• EC 3 History of previous left atrial ablation or surgical treatment for AF/AFL/AT
• EC 4 Atrial fibrillation secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
• EC 5 Structural heart disease as described below:
• Left ventricular ejection fraction (LVEF) < 40% based on most recent TTE
• Left atrial size > 55 mm (parasternal long axis view) documented within 6-months of screening
• NYHA Class III or IV heart failure documented within the previous 12-months
• An implanted pacemaker or ICD
• Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG),
• Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve
• Interatrial baffle, closure device, patch, or PFO occluder
• Presence of a left atrial appendage occlusion device
• Presence of any pulmonary vein stenting devices
• Coronary artery bypass graft (CABG) or PTCA procedure within 6 months prior to procedure
• Unstable angina or ongoing myocardial ischemia
• Myocardial infarction within the previous six (6) months prior to procedure
• Moderate or severe mitral insufficiency or stenosis based on most recent TTE
• Atrial myxoma
• Significant congential anomaly
• EC 6 BMI > 40
• BMI >35 and no prior sponsor approval into the study
• EC 7 Any previous history of cryoglobulinemia
• EC 8 History of blood clotting or bleeding disease
• EC 9 History of severe COPD requiring steroid use in the previous 12-months

Where it is running

• Grandview Medical Center — Birmingham, Alabama, United States
• Banner Health — Phoenix, Arizona, United States
• St. Bernards Medical Center — Jonesboro, Arkansas, United States
• University of California San Diego — San Diego, California, United States
• South Denver Cardiology Associates — Denver, Colorado, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Emory St. Joseph's Hospital — Atlanta, Georgia, United States
• Northwestern University — Evanston, Illinois, United States
• Prairie Heart Research Institute — Springfield, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• New Mexico Heart Institute — Albuquerque, New Mexico, United States
• Staten Island University Hospital - Northwell Health — Staten Island, New York, United States
• Ohio Health Research Institute — Columbus, Ohio, United States
• Baylor St. Luke's Medical Center — Houston, Texas, United States
• Onze Lieve Vrouwziekenhuis — Aalst, Belgium
• ZNA Middelheim — Antwerp, Belgium
• Southlake Regional Medical Centre — Newmarket, Ontario, Canada
• St. Antonius Ziekenhuis Nieuwegein — Nieuwegein, Netherlands
• Erasmus University Medical Center — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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