iCLAS™ for Persistent Atrial Fibrillation
Study Details
Study Description
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)
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: iCLAS Ablation Ablation of the left and right atrium with the Adagio Medical iCLAS System |
Device: Adagio AF Cryoablation System (iCLAS™)
Endovascular ablation of the left and right atrium
|
Outcome Measures
Primary Outcome Measures
- Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure. [12-months]
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
- Analysis of the proportion of subjects receiving a single cryoablation who are free from any documented left atrial arrhythmia (AF/AFL/AT). [12-months]
The primary effectiveness endpoint will be based on a centralized core lab interpretation of the recordings used in the endpoint analysis.
Secondary Outcome Measures
- Recording and analysis of all identified SAEs and SADEs through 12-months post-procedure. [12-months]
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)
- Analysis of the proportion of subjects with acute procedural (ablation) success [20-minutes following last ablation]
Documentation of pulmonary vein isolation and posterior wall isolation
Eligibility Criteria
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:
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Left ventricular ejection fraction (LVEF) < 40% based on most recent TTE
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Left atrial size > 55 mm (parasternal long axis view) documented within 6-months of screening
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NYHA Class III or IV heart failure documented within the previous 12-months
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An implanted pacemaker or ICD
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Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG),
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Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve
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Interatrial baffle, closure device, patch, or PFO occluder
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Presence of a left atrial appendage occlusion device
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Presence of any pulmonary vein stenting devices
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Coronary artery bypass graft (CABG) or PTCA procedure within 6 months prior to procedure
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Unstable angina or ongoing myocardial ischemia
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Myocardial infarction within the previous six (6) months prior to procedure
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Moderate or severe mitral insufficiency or stenosis based on most recent TTE
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Atrial myxoma
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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)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
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 |
5 | South Denver Cardiology Associates | Denver | Colorado | United States | 80120 |
6 | Mayo Clinic | Jacksonville | Florida | United States | 32224 |
7 | Emory St. Joseph's Hospital | Atlanta | Georgia | United States | 30342 |
8 | Northwestern University | Evanston | Illinois | United States | 60208 |
9 | Prairie Heart Research Institute | Springfield | Illinois | United States | 62701 |
10 | Johns Hopkins University | Baltimore | Maryland | United States | 21205 |
11 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
12 | The Valley Hospital | Ridgewood | New Jersey | United States | 07450 |
13 | New Mexico Heart Institute | Albuquerque | New Mexico | United States | 87102 |
14 | Ohio Health Research Institute | Columbus | Ohio | United States | 43214 |
15 | Baylor St. Luke's Medical Center | Houston | Texas | United States | 77030 |
16 | Onze Lieve Vrouwziekenhuis | Aalst | Belgium | ||
17 | ZNA Middelheim | Antwerp | Belgium | ||
18 | Southlake Regional Medical Centre | Newmarket | Ontario | Canada | L3Y 2P9 |
19 | St. Antonius Ziekenhuis Nieuwegein | Nieuwegein | Netherlands | ||
20 | Erasmus University Medical Center | Rotterdam | Netherlands | 3015 GD |
Sponsors and Collaborators
- Adagio Medical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CS-200