iCLAS™ for Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

Official title:

iCLAS™ for Persistent Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04061603
• Other study ID #: CS-200
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: August 30, 2024

Study information

• Verified date: January 2024
• Source: Adagio Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Adagio AF Cryoablation System (iCLAS™)
Endovascular ablation of the left and right atrium

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Adagio Medical

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Recording and analysis of all identified SAEs and SADEs through 12-months post-procedure.	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)	12-months
Secondary	Analysis of the proportion of subjects with acute procedural (ablation) success	Documentation of pulmonary vein isolation and posterior wall isolation	20-minutes following last ablation