A Study to Evaluate the Adagio System to Treat Persistent Atrial Fibrillation

Overview

About this study

The purpose of this study is to provide safety and effectiveness data regarding the use of the Adagio System in the treatment of Persistent Atrial Fibrillation (PsAF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female, between the ages of 18 and 80 years.
  • 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:
    • Physician’s note indicating continuous AF > 7 days and ≤ 12 months; and
    • One of the following:
    • 24-hour Holter within 180 days of enrollment showing continuous AF; or
    • 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..
  • Refractory to at least one class I or III AAD. (Refractory defined as not effective, not tolerated or not desired).
  • 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:

  • 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.
  • 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.
  • 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.
  • BMI > 40.
    • BMI > 35 and no prior sponsor approval into the study.
  • Any previous history of cryoglobulinemia.
  • History of blood clotting or bleeding disease.
  • History of severe COPD requiring steroid use in the previous 12-months.
  • History of severe sleep apnea (AHI > 30) not currently treated with a CPAP machine or other mechanical device.
  • Any prior history of documented cerebral infarct including recent TIA (within one year) or systemic embolism (excluding a post-operative DVT)
  • 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 (current or anticipated during study follow-up).
  • 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.
  • 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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Fred Kusumoto, M.D.

Open for enrollment

Contact information:

Prachi Kulahalli B.S.

(904)953-3882

Kulahalli.Prachi@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20512788

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