Treatment of persistent atrial fibrillation using specialized devices during heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of the Cardioblate iRF and CryoFlex handheld devices for treating non-paroxysmal atrial fibrillation in patients undergoing cardiac surgery. It is a multi-center, single-arm, prospective, non-randomized interventional study involving up to 160 subjects across 25 centers in the US. Participants will be followed for 12 months post-procedure to assess outcomes related to the intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* History of non-paroxysmal AF (persistent or longstanding persistent)
* Concomitant indication for non-emergent open-heart surgery, eg,

  1. Coronary artery bypass grafting
  2. Valve repair or replacement
* Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)

Exclusion Criteria:

* Wolff-Parkinson-White syndrome
* New York Heart Association (NYHA) Class = IV
* Left Ventricular Ejection Fraction ≤ 30%
* Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
* Previous AF ablation, atrioventricular (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

Where it's running

• St Vincent Heart Center of Indiana
  Indianapolis, Indiana, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Corewell Health
  Grand Rapids, Michigan, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• Allegheny General Hospital
  Pittsburgh, Pennsylvania, United States Recruiting
• Virginia Mason Heart Institute
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Ralph J Damiano, MD — Washington University School of Medicine
• Study coordinator: Stephanie Yong
• Email: stephanie.yong@medtronic.com
• Phone: 763-526-2032

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• FARAFLEX Mapping and Pulsed Field Ablation for Atrial Fibrillation

  This trial tests the FARAFLEX Mapping and PFA System to see if it can safely help adults with drug-refractory paroxysmal or persistent atrial fibrillation.

  Recruiting at 13 sites Boston Scientific Corporation · Jonesboro, Arkansas and 12 other locations · NCT07575269

• Pulsed field ablation for atrial fibrillation in underrepresented minority patients

  This registry will test how well Boston Scientific pulsed field ablation works and how safe it is for Black, Hispanic, Asian, and other underrepresented adults with paroxysmal or persistent atrial fibrillation.

  Recruiting at 2 sites Icahn School of Medicine at Mount Sinai · New York, New York and 1 other locations · NCT07535268

• Left Atrial Appendage Occlusion and Rhythm Restoration in AF Patients

  This trial tests a combined procedure using the Volt PFA System and Amulet 2 to see if it safely and feasibly treats atrial fibrillation while also closing the left atrial appendage in adults with AF.

  Recruiting at 13 sites Abbott Medical Devices · Brussels, B CAP R and 15 other locations · NCT07523620

• Qidong Yixin Granules to prevent atrial fibrillation returning after ablation

  This trial tests whether taking Qidong Yixin Granules after catheter ablation can lower the chance of atrial fibrillation coming back within a year in adults with persistent AF.

  Recruiting Phase 4 Sir Run Run Shaw Hospital · Hangzhou and 4 other locations · NCT07508618

• FARAPULSE pulsed-field waveform treatment for paroxysmal and persistent atrial fibrillation

  This will test new pulsed electrical waveforms delivered by the FARAPULSE PFA system to treat adults with paroxysmal or persistent atrial fibrillation.

  Recruiting at 3 sites Boston Scientific Corporation · Split and 3 other locations · NCT07444320

• PVI Alone vs PVI Plus PWI and SVCI with PFA in Persistent AF

  This study tests whether adding posterior wall isolation and superior vena cava isolation to pulmonary vein isolation with pulsed-field ablation helps people with persistent atrial fibrillation stay in rhythm.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07405359

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.