Antithrombotic Therapy in Patients Undergoing CIED Surgery - HEMATOMA NO MORE Registry

Azienda Ospedaliera Universitaria Senese

Status: Completed

Conditions: Antithrombotic Drugs; Device Related Infection; Surgery--Complications; Cardiac Arrhythmia; Hematoma

Treatments: Other: CIED surgery

Study type: Observational

Funder types: Other

Identifiers

NCT03067909

HNM_V1

Details and patient eligibility

About

Hundreds of thousands patients undergo implantation or replacement of cardiac implantable electronic devices (CIEDs) annually in Europe, and up to 50% of these subjects receive antiplatelet agents or oral anticoagulants. Antithrombotic therapy increases the risk of developing pocket hematoma which in turn is associated with an increased risk of potentially fatal device-related infections when clinically significant. Aim of the registry is to retrospectively (pilot local registry in Tuscany) and prospectively (multicenter national registry in Italy) investigate the different strategies for the management of antithrombotic therapy and the related complication rates (1-month and 12-months) in patients undergoing CIED surgery in a real-world setting. The registry will also provide data on the economic impact of different management strategies and complications.

Enrollment: 1,450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with standard indications to CIED surgery being treated with antiplatelet agents and/or anticoagulants (any commercially available device or approved and marketed drug can be included).
• Patients able to provide written informed consent
• Patients willing to attend the planned follow-up visits

Exclusion criteria

• Patient with life expectancy less than 12 months as per investigator's judgement

Trial design

1,450 participants in 1 patient group

Patients undergoing CIED surgery

Description:

Patients with standard indications to CIED implantations/replacements receiving concomitant antithrombotic therapy (either or both antiplatelet agents and/or anticoagulants).

Treatment:

Other: CIED surgery