Direct Oral Anticoagulant Management for Cardiac Device Implantation

• Conditions: Anticoagulant, Perioperative

• Registration Number: NCT03879473
• Lead Sponsor: Institut Necker Enfants Malades

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-15
• Last Update Submitted: 2019-03-15
• Study First Posted: 2019-03-18
• Last Update Posted: 2019-03-18
• Primary Completion: 2020-02
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 680

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of patients with clinically significant pocket hematoma	30 +/- 5 days	hematoma requiring reoperation, and/or resulting in prolongation of hospitalization, and/or requiring interruption of all anticoagulation.

Secondary Outcome Measures

Name	Time	Method
number of patients with thromboembolic event	30 +/- 5 days	transient ischemic attack, stroke, peripheral embolus, venous thromboembolism

Trial Locations

Locations (1)

HEGP; 🇫🇷 Paris, France