iCLAS™ for Persistent Atrial Fibrillation
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04061603 |
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Recruitment Status :
Recruiting
First Posted : August 20, 2019
Last Update Posted : December 16, 2022
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| Tracking Information | |||||||||
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| First Submitted Date ICMJE | August 16, 2019 | ||||||||
| First Posted Date ICMJE | August 20, 2019 | ||||||||
| Last Update Posted Date | December 16, 2022 | ||||||||
| Actual Study Start Date ICMJE | December 9, 2019 | ||||||||
| Estimated Primary Completion Date | December 9, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | iCLAS™ for Persistent Atrial Fibrillation | ||||||||
| Official Title ICMJE | iCLAS™ for Persistent Atrial Fibrillation | ||||||||
| 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Symptomatic persistent atrial fibrillation that failed at least one class I or Class III AAD with no prior history of ablation Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Persistent Atrial Fibrillation | ||||||||
| Intervention ICMJE | Device: Adagio AF Cryoablation System (iCLAS™)
Endovascular ablation of the left and right atrium
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| Study Arms ICMJE | Experimental: iCLAS Ablation
Ablation of the left and right atrium with the Adagio Medical iCLAS System
Intervention: Device: Adagio AF Cryoablation System (iCLAS™)
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
200 | ||||||||
| Original Estimated Enrollment ICMJE |
30 | ||||||||
| Estimated Study Completion Date ICMJE | December 9, 2023 | ||||||||
| Estimated Primary Completion Date | December 9, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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) |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Belgium, Canada, Netherlands, United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04061603 | ||||||||
| Other Study ID Numbers ICMJE | CS-200 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | Adagio Medical | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor ICMJE | Adagio Medical | ||||||||
| Original Study Sponsor ICMJE | Same as current | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Adagio Medical | ||||||||
| Verification Date | December 2022 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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