Direct Oral Anticoagulant Management for Cardiac Device Implantation

NCT03879473 | Unknown

• 1 other identifier: CV185-614
• Study Type: observational
• Target: 680
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulant, Perioperative

Outcome Measures

Primary Outcomes (1)

• number of patients with clinically significant pocket hematoma

  hematoma requiring reoperation, and/or resulting in prolongation of hospitalization, and/or requiring interruption of all anticoagulation.

  30 +/- 5 days

Secondary Outcomes (1)

• number of patients with thromboembolic event

  30 +/- 5 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Institut Necker Enfants Malades: lead

Study Sites (1)

HEGP

Paris, 75000, France

RECRUITING

Study Officials

• Anne-Céline Martin, MD, PhD

  INSERM 1140

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nassima Oukkal

CONTACT

01 56 09 20 00; nassima.oukkal-ext@aphp.fr

Nassima Oukkal

CONTACT

nassima.oukkal-ext@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 18, 2019

Record last verified: 2019-03

Locations

FR (1)