The study will gain information on 3D movements / curvatures of the Reliance 4-Front and Reliance 4-Site ICD leads in vivo. We expect that the movements will be influenced by the type of lead (lead stiffness, which is different between the 2 lead…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To quantify the in vivo cyclic curvature in the extravenous region and
connector region of Reliance 4-Site and Reliance 4-Front leads for a random
sample of patients implanted with ICD and CRT-D systems.
Secondary outcome
1) to correlate in vivo cyclic curvature in the extravenous region and
connector region with certain predefined dimensions that locate the defined
lead trajectory and locate the pulse generator with respect to anatomical
landmarks.
2) to compare in vivo cyclic curvature between the Reliance 4-Site and Reliance
4-Front leads. The stiffness of both leads is different, which could influence
curvature
Background summary
Implantable cardiac defibrillator (ICD)-leads are intended to last a lifetime
without repair or replacement. However the leads are subject to degradation and
can be damaged by forces when implanted in vivo. These forces are caused by use
of the arm leading to scraping of the lead to other structures causing
abrasion, or metal fatigue. Engineers perform bench tests to optimize lead
design. However the current bench tests do not account for forces applied on
the leads in vivo. This information can be obtained by studying in vivo
3D-curvatures of ICD-leads in patients with an ICD.
Study objective
The study will gain information on 3D movements / curvatures of the Reliance
4-Front and Reliance 4-Site ICD leads in vivo. We expect that the movements
will be influenced by the type of lead (lead stiffness, which is different
between the 2 lead types), location of ICD generator, lead length between vein
entry site and generator. This knowledge can be used to improve implantation
techniques and ICD-lead design to prevent degradation of ICD-leads. The
long-term reliability of ICD-leads will be improved and future patients will
benefit.
Study design
It is a prospective observational study in patients.
Study burden and risks
Patients are asked to visit the UMC Utrecht once, the visit will take 2 hours.
We will use radiation with an expected dose of 0,35 mSv. As a comparison: the
usual background radiation in The Netherlands is ~2,5 mSv each year. The amount
of radiation that will be used has a low risk of harmful effects.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62029.041.17 |