NCT02331511

Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

Effect of Aspirin and Clopidogrel in Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Complication of Cardiac Defibrillator
• Disorder of Cardiac Pacemaker System
• Venous Occlusion

Interventions

Type	Name	Description
DRUG	placebo	placebo administration for 3 months after device(PPM,ICD,CRT) implantation
DRUG	Aspirin 80 mg daily	Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation
DRUG	Clopidogrel 75 mg daily	Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2015-01-06
• Last updated: 2015-10-29

Locations

1 site across 1 country: Iran