Preliminary evaluation of defibrillator lead curvature in vivo
Completed
- Conditions
- ICD (implantable cardiac defibrillator)implantation technique10007521
- Registration Number
- NL-OMON47524
- Lead Sponsor
- Cardiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
-Age 18-90 years
-Patients with implantable defibrillator systems with either Reliance 4-Site or Reliance 4-Front leads who are followed at the University Medical Center, Utrecht
-Patients capable of providing informed consent.
Exclusion Criteria
Pregnancy
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To quantify the in vivo cyclic curvature in the extravenous region and<br /><br>connector region of Reliance 4-Site and Reliance 4-Front leads for a random<br /><br>sample of patients implanted with ICD and CRT-D systems. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1) to correlate in vivo cyclic curvature in the extravenous region and<br /><br>connector region with certain predefined dimensions that locate the defined<br /><br>lead trajectory and locate the pulse generator with respect to anatomical<br /><br>landmarks.<br /><br>2) to compare in vivo cyclic curvature between the Reliance 4-Site and Reliance<br /><br>4-Front leads. The stiffness of both leads is different, which could influence<br /><br>curvature</p><br>