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Direct Oral Anticoagulant Management for Cardiac Device Implantation

Influence of Peri-procedural Management of Direct Oral Anticoagulants on the Incidence of Pocket Hematoma in Patients Undergoing Cardiac Rhythm Device Implantation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03879473
Acronym
StimAOD
Enrollment
680
Registered
2019-03-18
Start date
2019-02-01
Completion date
2020-03-31
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulant, Perioperative

Brief summary

Each year, tens of thousands of cardiac rhythm devices including pacemaker (PM) or implantable cardioverter-defibrillator (ICD) are implanted in France. More than 25% of patients undergoing cardiac device implantation receive long-term anticoagulation therapy, that increases the incidence of pocket hematoma with potential serious consequences for patients. Although more and more patients receive direct oral anticoagulants (DOACs), limited data currently exist on the perioperative management of DOAC-treated patients undergoing cardiac device implantation and the optimal strategy remains unclear. Especially, the time of DOAC resumption after the procedure is controversial. We hypothesize that the time of DOAC resumption is the main risk factor of bleeding event in DOAC-treated patients undergoing cardiac device implantation, that is to say that a delayed DOAC resumption \> 48 hours following the procedure will reduce pocket hematoma incidence compared with an early resumption, ≤ 48 hours, without increasing thromboembolic events. We propose here an observational multicentre national study to find out the optimal strategy.

Interventions

None listed

Sponsors

Institut Necker Enfants Malades
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* receiving DOAC (apixaban, rivaroxaban, dabigatran) for stroke prevention in atrial fibrillation at least 5 days prior to enrolment * undergoing a cardiac rhythm device implantation (implantation or replacement of PM (1 or 2 leads) and ICD (1or 2 leads) with or without cardiac-resynchronization therapy * informed

Design outcomes

Primary

MeasureTime frameDescription
number of patients with clinically significant pocket hematoma30 +/- 5 dayshematoma requiring reoperation, and/or resulting in prolongation of hospitalization, and/or requiring interruption of all anticoagulation.

Secondary

MeasureTime frameDescription
number of patients with thromboembolic event30 +/- 5 daystransient ischemic attack, stroke, peripheral embolus, venous thromboembolism

Countries

France

Contacts

Primary ContactNassima Oukkal
nassima.oukkal-ext@aphp.fr01 56 09 20 00
Backup ContactNassima Oukkal
nassima.oukkal-ext@aphp.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026