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Status:

ACTIVE_NOT_RECRUITING

iCLAS™ for Persistent Atrial Fibrillation

Lead Sponsor:

Adagio Medical

Conditions:

Persistent Atrial Fibrillation

Eligibility:

All Genders

18-80 years

Phase:

NA

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 s...

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 symp...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    December 9 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 30 2024

    Estimated Enrollment :

    200 Patients enrolled

    Trial Details

    Trial ID

    NCT04061603

    Start Date

    December 9 2019

    End Date

    August 30 2024

    Last Update

    April 24 2024

    Active Locations (21)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (21 locations)

    1

    Grandview Medical Center

    Birmingham, Alabama, United States, 35243

    2

    Banner Health

    Phoenix, Arizona, United States, 85006

    3

    St. Bernards Medical Center

    Jonesboro, Arkansas, United States, 72401

    4

    University of California San Diego

    San Diego, California, United States, 92093