Atrial Fibrillation Trial, Recruiting NCT03546374 Sponsor: Medtronic Cardiac Surgery Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT03546374
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have a persistent or long-standing persistent form of atrial fibrillation (an irregular heartbeat that does not come and go but stays ongoing)
  • People who already need non-emergency open-heart surgery for another reason, such as a heart bypass operation or heart valve repair or replacement
  • People who are able to take blood-thinning medication, either warfarin or one of the newer types of blood thinners known as NOACs

Who may not be able to join:

  • People who have a heart condition called Wolff-Parkinson-White syndrome
  • People whose heart failure has been classified as the most severe level (Class IV) by their doctor
  • People whose heart pumping strength (left ventricular ejection fraction) is at or below 30%
  • People who need emergency heart surgery, such as for cardiogenic shock (when the heart suddenly cannot pump enough blood), or who have already had open-heart surgery before
  • People who have previously had a procedure to treat their atrial fibrillation, including catheter ablation, AV-node ablation, or a surgical Maze procedure
  • People who are unable to take blood-thinning medication for medical reasons
  • People whose left atrial chamber (one of the heart's upper chambers) measures more than 6.0 cm
  • People who need a heart-assist balloon pump or strong heart medications given through a drip before surgery
  • People who have kidney failure requiring dialysis, or serious liver failure
  • People whose life expectancy is estimated to be less than one year
  • People whose estimated risk of not surviving the operation is greater than 10%, based on a standard surgical risk calculator
  • People who are pregnant or plan to become pregnant within 12 months of the study treatment
  • People who currently have an active infection anywhere in the body
  • People who currently have an active infection of the heart valves (endocarditis)
  • People who had a heart attack in the 30 days before enrolling in the study
  • People who are currently taking part in, or planning to join, another trial or observational study involving a drug or device for treating heart rhythm problems

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Ralph J Damiano, MD, Washington University School of Medicine

Phone: 763-526-2032

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Medtronic Cardiac Surgery
Registry
ClinicalTrials.gov
Start date
15 November 2018
Est. completion
1 October 2024

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Composite acute major adverse event rate; Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov