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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03067909
Other study ID # HNM_V1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2016
Est. completion date December 2018

Study information

Verified date February 2019
Source Azienda Ospedaliera Universitaria Senese
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1450
Est. completion date December 2018
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
CIED surgery


Locations

Country Name City State
Italy AOU Senese Siena

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria Senese

Country where clinical trial is conducted

Italy, 

References & Publications (2)

V Zaca', A Angeletti, C Baiocchi, M Bertini, M Biffi, P Busacca, M Iori, M Mezzetti, M Nesti, P Notarstefano; P3213 Real-world periprocedural management of antithrombotic therapy in patients undergoing electrophysiological device surgery: preliminary results of the HEMATOMA NO MORE, European Heart Journal, Volume 39, Issue suppl_1, 1 August 2018, ehy563.P3213, https://doi.org/10.1093/eurheartj/ehy563.P3213

Zacà V, Breschi M, Mandorli A, Panchetti L, Ricciardi G, Viani S, Notarstefano P. Rationale, study design, and pilot phase of tHE Management of AntiThrOMbotic therApy (HEMATOMA) in patients undergoing electrophysiological device surgery: Italian National Multicenter Observational REgistry. J Cardiovasc Med (Hagerstown). 2017 Nov;18(11):897-899. doi: 10.2459/JCM.0000000000000534. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinically significant pocket hematoma Post-procedural hematoma resulting in prolonged hospitalization and/or requiring interruption of antithrombotic therapy and/or requiring further surgery and/or requiring transfusion One month
Secondary Non-clinically significant pocket hematoma Post-procedural hematoma not meeting diagnostic criteria for clinically significant One month
Secondary Hemorrhagic complications other than pocket hematoma Hemothorax, cardiac tamponade, pericardial effusion, intracranial hemorrhage One month
Secondary Thromboembolic complications Transient ischemic attack, ischemic stroke, deep venous thrombosis, pulmonary embolism, systemic embolic event, acute myocardial infarction, prosthetic cardiac valve thrombosis Twelve months
Secondary All cause death Twelve months
Secondary CIED-related infection Twelve months
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