iCLAS™ for Persistent Atrial Fibrillation

NCT ID: NCT04061603

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2024-08-30

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.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iCLAS Ablation

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

Group Type: EXPERIMENTAL

Adagio AF Cryoablation System (iCLAS™)

Intervention Type: DEVICE

Endovascular ablation of the left and right atrium

Interventions

Adagio AF Cryoablation System (iCLAS™)

Endovascular ablation of the left and right atrium

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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:

1. Left ventricular ejection fraction (LVEF) < 40% based on most recent TTE

2. Left atrial size > 55 mm (parasternal long axis view) documented within 6-months of screening

3. NYHA Class III or IV heart failure documented within the previous 12-months

4. An implanted pacemaker or ICD

5. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG),

6. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve

7. Interatrial baffle, closure device, patch, or PFO occluder

8. Presence of a left atrial appendage occlusion device

9. Presence of any pulmonary vein stenting devices

10. Coronary artery bypass graft (CABG) or PTCA procedure within 6 months prior to procedure

11. Unstable angina or ongoing myocardial ischemia

12. Myocardial infarction within the previous six (6) months prior to procedure

13. Moderate or severe mitral insufficiency or stenosis based on most recent TTE

14. Atrial myxoma

15. 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

EC 10 History of severe sleep apnea (AHI > 30) not currently treated with a CPAP machine or other mechanical device

EC 11 Any prior history of documented cerebral infarct including recent TIA (within one year) or systemic embolism (excluding a post-operative DVT)

EC 12 Any prior history or current evidence of hemidiaphragmatic paralysis

EC 13 Pregnant or lactating (current or anticipated during study follow-up)

EC 14 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study

EC 15 Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center, COVID-19 related concerns)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adagio Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suneet Mittal, MD

Role: PRINCIPAL_INVESTIGATOR

Valley Hospital

Locations

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

Countries

United States; Belgium; Canada; Netherlands

Other Identifiers

CS-200

Identifier Type: -

Identifier Source: org_study_id