Obtain information on the spatial movement and deflection of implanted leads by capturing three cardiac cycles with a simultaneous biplane cinefluoroscopy imaging system. The lead movement and deflection data will be used to evaluate the lead strain…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
No primary or secondary endpoints were defined.
Secondary outcome
Data of interest in addition to the biplane cinefluoroscopy are:
- Patient characteristics
- ICD/CRT-D therapy characteristics, including data about implantation procedure
- X-ray procedural data
- Termination of individual patient study participation
- Adverse and serious adverse events
Exploratory data analyses will be used to describe the patient population.
Background summary
An Implantable Cardioverter Defibrillator (ICD) system or a Cardiac
Resynchronization Therapy (CRT) device with Defibrillator function (CRT-D)
system consist of the device itself and one or more connected lead(s), that are
placed with their electrical active electrodes into the heart.
In vivo lead motion and performance became a new focus in the clinical and
regulatory field with the reported lead-related complications such as
perforation issues reported for Riata or Sprint Fidelis leads.
During implantation or relocation procedures a physician uses X-ray imaging
sequences from different views (angles) routinely to assess lead positioning
and performance in dependence of the current patient and procedure situation.
But these data can not be used to systematically reproduce lead positioning and
behaviour due to the absence of an obligatory standardized preset for the
imaging system and projection.
Moreover the development of a new ISO standard is in progress to formulate
requirements on lead fatigue performance based on in vivo lead motion data.
Currently, the ISO standard is based on well established harmonized testing
methods, but they do not take account of product specific characteristics [6].
It is currently under discussion if new different testing procedures are
necessary for different lead models. Therefore the analysis of in vivo lead
motion (use condition) is a prerequisite.
Study objective
Obtain information on the spatial movement and deflection of implanted leads by
capturing three cardiac cycles with a simultaneous biplane cinefluoroscopy
imaging system. The lead movement and deflection data will be used to evaluate
the lead strain.
Study design
Prospective, non-randomized, single-center feasibility investigation with an
enrollment target of 45 patients
Study burden and risks
The study related risks that are based on the cinefluoroscopy procedure are
potential long term effects related to exposing the patients to X-ray during
the cinefluoroscopy procedure (maximal two attempts of approximately 4 seconds
and the previous positioning process).It is known, that each radiation exposure
can lead to an increase of risk to development cancer or other radiation side
effects, most likely on an incremental pattern. On the other hand, fluoroscopy
and CT procedures are the common clinical standard for in vivo imaging
procedures, particularly in cases of suspicion of potential lead issues. The
compliance to the ALARA principle for the application of radiation is mandatory
for each physician and medical staff and minimizes the risk for all involved
persons.
The patient may directly benefit from possible findings or observations,
eventuated by the cinefluoroscopy, which could prevent potential unobserved
risks.
The main long term clinical benefit will derive from substantial improvements
in lead development and testing, ultimately affecting patient safety and
prolonging lead replacement cycles.
Woermannkehre 1
Berlin 12359
DE
Woermannkehre 1
Berlin 12359
DE
Listed location countries
Age
Inclusion criteria
· Patient has provided written informed consent
· Patient has a BIOTRONIK ICD or CRT-D
· Patient has at least a BIOTRONIK Linoxsmart S-DX lead or any other BIOTRONIK lead model
· Data about the implantation of the ICD/CRT-D, the lead(s) and the implanting physician are available at the investigation site
· Patient is able to attend the X-ray procedure following a routine follow-up visit
· None of the leads was implanted within the last three months
· Patient had no cardiac intervention within the last two months
· Patient has legal capacity and ability to consent
Exclusion criteria
· Age <18 years
· Patient is pregnant or breastfeeding
· Any complication of the implanted system at the time of enrollment
· Applicable patient subgroup is closed for enrollment
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 | NL51377.078.14 |