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 |
Recruitment Status :
Recruiting
First Posted : August 20, 2019
Last Update Posted : December 16, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Persistent Atrial Fibrillation | Device: Adagio AF Cryoablation System (iCLAS™) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
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 |
Official Title: | iCLAS™ for Persistent Atrial Fibrillation |
Actual Study Start Date : | December 9, 2019 |
Estimated Primary Completion Date : | December 9, 2023 |
Estimated Study Completion Date : | December 9, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: iCLAS Ablation
Ablation of the left and right atrium with the Adagio Medical iCLAS System
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Device: Adagio AF Cryoablation System (iCLAS™)
Endovascular ablation of the left and right atrium |
- Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure. [ Time Frame: 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). [ Time Frame: 12-months ]The primary effectiveness endpoint will be based on a centralized core lab interpretation of the recordings used in the endpoint analysis.
- Recording and analysis of all identified SAEs and SADEs through 12-months post-procedure. [ Time Frame: 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 [ Time Frame: 20-minutes following last ablation ]Documentation of pulmonary vein isolation and posterior wall isolation

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061603
Contact: Elaine Karaelias | 714-345-4045 | ekaraelias@adagiomedical.com | |
Contact: Nabil Jubran | 949-348-1188 ext 207 | njubran@adagiomedical.com |

Responsible Party: | Adagio Medical |
ClinicalTrials.gov Identifier: | NCT04061603 |
Other Study ID Numbers: |
CS-200 |
First Posted: | August 20, 2019 Key Record Dates |
Last Update Posted: | December 16, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |