Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

Shahid Beheshti University of Medical Sciences100 enrolled

Overview

The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.

There are growing numbers of endocardial permanent pacemakers (PPM) and implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) device. Asymptomatic obstruction of the access vein reported to have a high incidence (30-50%) in some studies. This complication can cause some difficulties in follow up procedures such as device upgrading. The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Complication of Cardiac Defibrillator Disorder of Cardiac Pacemaker System Venous Occlusion

Interventions

placeboDRUG

placebo administration for 3 months after device(PPM,ICD,CRT) implantation

Aspirin 80 mg dailyDRUG

Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation

Clopidogrel 75 mg dailyDRUG

Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients who referred for first implantation of pacemaker, implantable cardiac defibrillator, or cardiac re synchronization therapy device Exclusion Criteria: * history of malignancy * history of coagulopathy or platelet disorder * history of venous thromboembolism * history of gastrointestinal hemorrhage or active gastroduodenal ulcer in past 6 months * history of chronic kidney disorder or serum creatinine more than 1.5 mg/dl * patients who are on anticoagulant or other antithrombotic drugs or who must be on dual antiplatelet therapy.

Locations (1)

Shahid ModaressHospital

Tehran, Tehran Province, Iran

RECRUITING

Outcomes

Primary Outcomes

Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)

Time frame: 3 months

Secondary Outcomes

major bleeding

Time frame: 3 months

A composite of death of any cause, myocardial infarction, or cerebrovascular accident.

Time frame: 3 months

Central Contacts

Mohammad Ali Akbarzadeh, M.D.

CONTACT

+98 917 317 1001 akbarzadehali@yahoo.com

Data from ClinicalTrials.gov

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