iCLAS™ for Persistent Atrial Fibrillation

NCT04061603 | Completed DMC FDA Device

• 1 other identifier: CS-200
• Study Type: interventional
• Target: 215
• Locations: 4 countries
• Sites: 21

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)

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure.

  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 System

  12-months

• Analysis of the proportion of subjects receiving a single cryoablation who are free from any documented left atrial arrhythmia (AF/AFL/AT).

  The primary effectiveness endpoint will be based on a centralized core lab interpretation of the recordings used in the endpoint analysis.

  12-months

Secondary Outcomes (2)

• Recording and analysis of all identified SAEs and SADEs through 12-months post-procedure.

  12-months

• Analysis of the proportion of subjects with acute procedural (ablation) success

  20-minutes following last ablation

Study Arms (1)

iCLAS Ablation

EXPERIMENTAL

Ablation of the left and right atrium with the Adagio Medical iCLAS System

Device: Adagio AF Cryoablation System (iCLAS™)

Interventions

Adagio AF Cryoablation System (iCLAS™) DEVICE

Endovascular ablation of the left and right atrium

iCLAS Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Adagio Medical: lead

Study Sites (21)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Banner Health

Phoenix, Arizona, 85006, United States

Location

St. Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

Location

University of California San Diego

San Diego, California, 92093, United States

Location

South Denver Cardiology Associates

Denver, Colorado, 80120, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Emory St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Prairie Heart Research Institute

Springfield, Illinois, 62701, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Staten Island University Hospital - Northwell Health

Staten Island, New York, 10305, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Onze Lieve Vrouwziekenhuis

Aalst, Belgium

Location

ZNA Middelheim

Antwerp, Belgium

Location

Southlake Regional Medical Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Netherlands

Location

Erasmus University Medical Center

Rotterdam, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suneet Mittal, MD

  Valley Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Symptomatic persistent atrial fibrillation that failed at least one class I or Class III AAD with no prior history of ablation

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 20, 2019
• Study Start: December 9, 2019
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2024
• Last Updated: April 13, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); CA (1); US (16); BE (2)