Clinical trial NCT04061603: iCLAS™ for Persistent Atrial Fibrillation
Official title: iCLAS™ for Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Adagio Medical
Sponsor class: INDUSTRY
First posted: 2019-08-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Symptomatic persistent atrial fibrillation that failed at least one class I or Class III AAD with no prior history of ablation
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure.
timeFrame: 12-months
measure: Analysis of the proportion of subjects receiving a single cryoablation who are free from any documented left atrial arrhythmia (AF/AFL/AT).
timeFrame: 12-months
Secondary outcomes:
measure: Recording and analysis of all identified SAEs and SADEs through 12-months post-procedure.
timeFrame: 12-months
measure: Analysis of the proportion of subjects with acute procedural (ablation) success
timeFrame: 20-minutes following last ablation
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Banner Health
state: Arizona
city: Jonesboro
country: United States
facility: St. Bernards Medical Center
state: Arkansas
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Denver
country: United States
facility: South Denver Cardiology Associates
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Atlanta
country: United States
facility: Emory St. Joseph's Hospital
state: Georgia
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Springfield
country: United States
facility: Prairie Heart Research Institute
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Staten Island
country: United States
facility: Staten Island University Hospital - Northwell Health
state: New York
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
city: Aalst
country: Belgium
facility: Onze Lieve Vrouwziekenhuis
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Newmarket
country: Canada
facility: Southlake Regional Medical Centre
state: Ontario
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
affiliation: Valley Hospital
name: Suneet Mittal, MD
role: PRINCIPAL_INVESTIGATOR
References: