Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Saint Helena, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal AF.

Official Title

Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)

Details

This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the US. The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months. The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.

Keywords

Persistent Atrial Fibrillation Longstanding Persistent Atrial Fibrillation Atrial Fibrillation Surgical Ablation Cardioblate and Cryoflex hand held devices

Eligibility

You can join if…

Open to people ages 18 years and up

  1. History of non-paroxysmal AF (persistent or longstanding persistent)
  2. Concomitant indication for non-emergent open-heart surgery, eg,
  3. Coronary artery bypass grafting
  4. Valve repair or replacement
  5. Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)

You CAN'T join if...

  • Wolff-Parkinson-White syndrome
  • NYHA Class = IV
  • Left Ventricular Ejection Fraction ≤ 30%
  • Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
  • Previous AF ablation, AV-nodal ablation, or surgical Maze procedure
  • Contraindication for anticoagulation therapy
  • Left atrial diameter > 6.0 cm
  • Preoperative need for an intra-aortic balloon pump or intravenous inotropes
  • Renal failure requiring dialysis or hepatic failure
  • Life expectancy of less than 1 year
  • Predicted risk of operative mortality >10% as assessed by STS Risk Calculator
  • Pregnancy or desire to be pregnant within 12 months of the study treatment
  • Current diagnosis of active systemic infection
  • Active endocarditis
  • Documented MI 30 days prior to study enrollment
  • Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias

Locations

  • Adventist Health St. Helena accepting new patients
    Saint Helena California 94574 United States
  • Stanford Hospitals and Clinic accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Cardiac Surgery
Links
Sign up for this study
ID
NCT03546374
Study Type
Interventional
Participants
Expecting 160 study participants
Last Updated