Status:
ACTIVE_NOT_RECRUITING
iCLAS™ for Persistent Atrial Fibrillation
Lead Sponsor:
Adagio Medical
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
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 s...
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 symp...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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)
Exclusion
Key Trial Info
Start Date :
December 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04061603
Start Date
December 9 2019
End Date
August 30 2024
Last Update
April 24 2024
Active Locations (21)
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1
Grandview Medical Center
Birmingham, Alabama, United States, 35243
2
Banner Health
Phoenix, Arizona, United States, 85006
3
St. Bernards Medical Center
Jonesboro, Arkansas, United States, 72401
4
University of California San Diego
San Diego, California, United States, 92093