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New Blood-Thinner strategy aims to cut bleeding after heart device implants

NCT ID NCT07616414

Disease control Sponsor: Fu Wai Hospital, Beijing, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a stepwise blood-thinning approach to the standard method in 424 patients with atrial fibrillation who are at high risk for stroke and need a heart device like a pacemaker. The stepwise plan involves stopping the blood thinner one day before surgery and restarting with a lower dose for a week afterward. The goal is to see if this reduces pocket hematoma (bleeding under the skin) within 30 days after surgery, while still preventing blood clots.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
edoxaban or rivaroxaban (blood thinners)
What this could lead to
If successful, this could offer a safer way to manage blood thinners around heart device surgery, reducing bleeding complications while still preventing strokes.
What could go wrong
This is an early-stage trial with only 424 participants, so results may not apply to all patients. The stepwise approach might not lower bleeding risk as expected or could increase stroke risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 424 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged 18 years or older at the time of screening, and able to provide written informed consent; 2. Scheduled for any CIED procedure (implantation or generator replacement), including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices; 3. Receiving NOAC therapy for at least 5 consecutive days prior to enrollment; 4. 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. Exclusion Criteria: 1. Presence of active systemic or local infection at the time of screening; 2. Estimated glomerular filtration rate (eGFR) \<30 mL/min, or any other contraindication to NOAC use; 3. Active bleeding (e.g., gastrointestinal bleeding); 4. Severe thrombocytopenia, defined as platelet count \< 50 × 10⁹/L at screening; 5. Life expectancy \<1 year; 6. Pregnancy.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Thromboembolism venous thromboembolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac implantable electronic device Hematoma postoperative Non-valvular atrial fibrillation (NVAF) Perioperative bleeding Thromboembolism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fuwai Hospital

    Beijing, Beijing Municipality, 100037, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.