Virtual management of anticoagulant therapy for patients needing elective 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

The PAUSE-Virtual study aims to evaluate the safety and effectiveness of managing anticoagulant therapy for patients with atrial fibrillation who require elective surgery through virtual visits instead of traditional in-person consultations. This observational study will assess whether virtual appointments can provide the same level of care and safety in terms of stroke and bleeding risks as in-person visits. Participants will receive guidance on when to stop and restart their blood thinners and instructions on self-administering short-acting anticoagulants if necessary. The study is particularly relevant in the context of changes in healthcare delivery due to the COVID-19 pandemic.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years of age or older with AF/flutter (chronic, persistent, paroxysmal) that requires anticoagulation
* Receiving warfarin, with a target international normalized ratio (INR) range of 2.0-3.0, or a DOAC, comprising one of the following regimens: apixaban, 2.5 mg or 5 mg bid; edoxaban, 30 mg or 60 mg daily; dabigatran, 110 mg or 150 mg bid; or rivaroxaban, 15 mg or 20 mg daily
* Require an elective (planned, non-urgent) surgery or invasive medical or surgical procedure

Exclusion Criteria:

* Indication for anticoagulation is not AF/flutter (e.g., mechanical heart valve, VTE, other)
* Non-standard anticoagulant regimen used (e.g., warfarin INR 3-4, rivaroxaban 2.5 mg bid)
* In DOAC users only: creatinine clearance \<25 mL/min (that preclude DOAC use)
* Cognitive impairment or psychiatric illness (that precludes reliable contact during follow-up)
* Unable or unwilling to provide consent for virtual care (in-person care will be provided)
* Previous participation in this study for an elective surgery/procedure

Where it's running

• Endeavor Health - Northshore
  Evanston, Illinois, United States Recruiting
• Henry Ford
  Detroit, Michigan, United States Recruiting
• Northwell Health
  Great Neck, New York, United States Recruiting
• Thomas Jefferson University Hospital
  Philadelphia, Pennsylvania, United States Recruiting
• QEII Health Sciences Centre
  Halifax, Nova Scotia, Canada Recruiting
• Hamilton General Hospital
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: James D Douketis, MD — McMaster University/St. Joseph's Healthcare
• Study coordinator: James D Douketis, MD
• Email: jdouket@mcmaster.ca
• Phone: 905-522-1155

Similar studies

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

• Pulsed Field vs Cryoballoon for Pulmonary Vein Isolation in Atrial Fibrillation

  This trial tests whether pulsed field ablation can shorten the procedure for first-time PVI in AF patients compared with cryoballoon ablation, while keeping safety and effectiveness similar.

  Recruiting St. Josefs-Hospital Wiesbaden GmbH · Wiesbaden · NCT07910370

• Pulsed Field Ablation vs Cryoablation for Atrial Fibrillation Under Deep Sedation

  This trial tests whether pulsed field ablation (PFA) done under deep sedation works as well as cryoballoon ablation for treating atrial fibrillation, aiming to avoid general anesthesia.

  Recruiting East Sussex Healthcare NHS Trust · Eastbourne · NCT07900685

• Bachmann’s Bundle Pacing vs Right Atrial Appendage Pacing for AF

  This study tests two common atrial pacing methods to see which one is safer over 12 months for people getting a new pacemaker, ICD, or CRT device.

  Recruiting Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Pittsburgh, Pennsylvania · NCT07874763

• AI-powered ECG to help diagnose and predict outcomes in heart disease

  Researchers test an AI-enhanced ECG to help diagnose and predict outcomes for people with cardiovascular diseases.

  Recruiting Inha University Hospital · Incheon, Incheon · NCT07856472

• Pace-and-ablate strategy in atrial fibrillation: who benefits and long-term outcomes

  This study looks at adults with atrial fibrillation who underwent AV node ablation with permanent pacing to see who develops pacing-induced problems and how they do long-term.

  Recruiting at 5 sites Insel Gruppe AG, University Hospital Bern · Zabrze and 4 other locations · NCT07852221

• AI-based cardiac analysis using 12-lead and 1-lead ECG

  A clinician-facing pilot test to see if SmartECG-EF helps evaluate heart function using both 12-lead and single-lead ECGs in adults with heart conditions.

  Recruiting Inha University Hospital · Incheon, Incheon · NCT07844434

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.