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Trial record 1 of 1 for:    NCT04061603
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iCLAS™ for Persistent Atrial Fibrillation

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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

Tracking Information
First Submitted Date  ICMJE August 16, 2019
First Posted Date  ICMJE August 20, 2019
Last Update Posted Date August 31, 2020
Actual Study Start Date  ICMJE December 9, 2019
Estimated Primary Completion Date December 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2019)
  • Procedure and Device Related Safety [ Time Frame: 12-months ]
    Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure.
  • Procedure and Device Long-term Efficacy [ Time Frame: 12-months ]
    Analysis of the proportion of subjects receiving a single cryoablation who are free from any documented left atrial arrhythmia (AF/AFL/AT) lasting longer than 30 seconds following the Blanking Period (3-months plus 14-days post index ablation) using a continuous ECG recording, 12-lead ECG or telemetry recording.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2019)
  • Procedure and Device Related Safety [ Time Frame: 12-months ]
    •Recording and analysis of all identified serious adverse events (SAEs) and serious adverse device effects (SADEs)
  • Acute Procedure and Device Efficacy [ Time Frame: 20-minutes following last ablation ]
    Documentation of pulmonary vein isolation and posterior wall isolation
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
Condition  ICMJE Persistent Atrial Fibrillation
Intervention  ICMJE Device: Adagio AF Cryoablation System (iCLAS™)
Endovascular ablation of the left and right atrium
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™)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 11, 2019)
200
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2019)
30
Estimated Study Completion Date  ICMJE December 9, 2021
Estimated Primary Completion Date December 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Holly Ng 949-348-1188 hng@adagiomedical.com
Contact: Nabil Jubran 949-348-1188 NJubran@adagiomedical.com
Listed Location Countries  ICMJE Belgium,   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
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adagio Medical
Study Sponsor  ICMJE Adagio Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Adagio Medical
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP