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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)
Full 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.
Enrollment
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Inclusion and exclusion 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:
EC 6 BMI > 40
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 purpose
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Interventional model
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200 participants in 1 patient group
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Central trial contact
Emily Hong; Nabil Jubran
Data sourced from clinicaltrials.gov
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