NCT07616414Not yet recruiting
Stepwise vs Standard Anticoagulation for AF Patients Undergoing CIED Implantation (STEP-AF)
Stepwise Versus Standard Antithrombotic Strategies in Patients With Atrial Fibrillation at High Thromboembolic Risk Undergoing CIED Procedures (STEP-AF Trial)
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
This is a multi-center, prospective, open-label, randomized controlled trial (STEP-AF) designed to evaluate the safety of a stepwise anticoagulation strategy compared with the guideline-recommended standard anticoagulation regimen in patients with non-valvular atrial fibrillation at high thromboembolic risk (CHA₂DS₂-VASc score ≥2) undergoing cardiac implantable electronic device (CIED) implantation. A total of 424 eligible patients will be randomized 1:1 to either the stepwise anticoagulation group (reduced-dose NOAC from 24 hours post-surgery to day 7, followed by standard-dose NOAC) or the standard anticoagulation group (standard-dose NOAC resumed 24 hours post-surgery). The primary endpoint is the incidence of clinically significant pocket hematoma within 30 days after surgery. Secondary endpoints include individual components of the primary endpoint and other composite outcomes of major perioperative bleeding events. The study aims to provide evidence-based data for optimizing perioperative anticoagulation regimens in Chinese patients undergoing CIED implantation.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 424 (estimated)
- First submitted
- 23 May 2026
- Start date
- 26 May 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Fu Wai Hospital, Beijing, China
- Diseases
- Atrial fibrillation
- NCT number
- NCT07616414
What you commit to
- Study type: Interventional
- Planned participants: 424
- From 26 May 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of active systemic or local infection at the time of screening;
- Active bleeding (e.g., gastrointestinal bleeding);
Lab values
- Estimated glomerular filtration rate (eGFR) \<30 mL/min, or any other contraindication to NOAC use;
- Severe thrombocytopenia, defined as platelet count \< 50 × 10⁹/L at screening;
Other
- Life expectancy \<1 year;
- Pregnancy.
Who the study is looking for
- Aged 18 years or older at the time of screening, and able to provide written informed consent;
- Scheduled for any CIED procedure (implantation or generator replacement), including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices;
- Receiving NOAC therapy for at least 5 consecutive days prior to enrollment;
- Diagnosed with non-valvular atrial fibrillation (and/or atrial flutter) with a CHA₂DS₂-VASc score ≥2, or scheduled for cardioversion or defibrillation threshold testing during the CIED procedure.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.