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iCLAS™ for Persistent Atrial Fibrillation

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 : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Adagio Medical

Study Description
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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
Persistent Atrial Fibrillation Device: Adagio AF Cryoablation System (iCLAS™) Not Applicable

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
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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, 2021
Estimated Study Completion Date : December 9, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

Male or female between the ages of 18 - 80 years

Currently scheduled for an ablation of symptomatic PsAF defined as continuous AF that is sustained > 7-days and ≤ 12-months.

Refractory to at least one class I or III AAD.

Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study

Willingness and ability to give an informed consent

Exclusion Criteria:

Any known contraindication to an atrial ablation, TEE, or anticoagulation.

Any duration of continuous AF lasting longer than 12-months

History of previous left atrial ablation or surgical treatment for AF/AFL/AT

Atrial fibrillation secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause

Significant structural heart disease

BMI > 35

Any previous history of cryoglobulinemia

History of blood clotting or bleeding disease

History of severe COPD requiring steriod use in the previous 12-months

History of obstructive sleep apnea not currently treated with a CPAP machine or other mechanical device

Any prior history of documented cerebral infarct or systemic embolism (excluding a post-operative DVT)

Any prior history or current evidence of hemidiaphragmatic paralysis

Pregnant or lactating women

Current enrollment in any other study where testing or results from that study may interfere with the procedure or outcome measurements for this study

Any other condition that, in the judgement of the investigator, makes the patient a poor candidate for this study

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Holly Ng 949-348-1188 hng@adagiomedical.com
Contact: Nabil Jubran 949-348-1188 NJubran@adagiomedical.com

Locations
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United States, Alabama
Grandview Medical Center Recruiting
Birmingham, Alabama, United States, 35243
Contact: Karen Burns, BSN, RN    205-971-7500    karen.burns@grandviewhealth.com   
Principal Investigator: Jose Osorio, MD         
Sub-Investigator: Gustavo Morales, MD         
Sub-Investigator: Anil Rajendra, MD         
United States, Georgia
Emory St. Joseph's Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Cindy Barnes, RN, CCRC    678-843-6093    cynthia.barnes@emory.edu   
Principal Investigator: David De Lurgio, MD         
United States, New Jersey
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Sarah Polites, BSN, RN, CCCRN-K    201-447-8453    spolite@valleyhealth.com   
Principal Investigator: Suneet Mittal, MD         
Sub-Investigator: Dan Musat, MD         
Belgium
Onze Lieve Vrouwziekenhuis Recruiting
Aalst, Belgium
Contact: Hedwig Batjeons    +3253724168    hedwig.batjeons@olvz-aalst.be   
Principal Investigator: Tom De Potter         
Sponsors and Collaborators
Adagio Medical
More Information
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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: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes