The objective of the study is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI* or Endurity MRI* pacemakers, in patients undergoing clinically indicated 3T MRI scans.
ID
Source
Brief title
Condition
- Other condition
- Cardiac arrhythmias
Synonym
Health condition
veiligheidsonderzoek in het kader van PMCF van MRI compatibele pacemaker in combinatie met 3T MRI
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint#1: Proportion of subjects with a capture threshold increase of
* 0.5V at the permanently programmed pulse width from pre- MRI scan to
one-month post MRI scan.
Secondary outcome
Primary Endpoint #2: Proportion of subjects with a sensing amplitude decrease
of * 50% from pre- MRI scan to one-month post MRI scan.
Background summary
The main cause for concern with MRI scans, more so with 3T than 1.5T scanners
due to their stronger electromagnetic fields (EMF), is the interaction between
the EMF used to generate the images and any devices (e.g. stents, pacemakers,
leads etc.) residing in the patient. Magnetic resonance imaging systems
generate the diagnostic image using three EMFs. These include a static
magnetic field, a time varying gradient magnetic field, and an RF field. All
three of these fields interact with implanted devices and could create hazards
for the device, the patient, or both. Examples of these hazards include
unwanted or incorrect cardiac stimulation, heating near lead electrodes, image
artifacts, and forces being applied to implanted components [7]. Due to these
issues, certain currently marketed implantable cardiac device systems,
including ICDs, may be contraindicated for use in an MRI environment,
especially in pacemaker dependent patients.
According to the 2009 World Survey of cardiac pacing and cardioverter
defibrillators, 282, 621 new pacemakers were implanted in 17 EU countries.
It is estimated that over 50% of the patients with implantable cardiac devices
will develop an indication for an MRI scan during the lifetime of their device.
Numerous reports have been published, of patients with implanted devices who
successfully underwent magnetic resonance imaging with 1.5T and 3T scanners
[9-11]. In most cases, the scans were performed under controlled conditions,
with careful telemetry monitoring of the patient by qualified personnel, during
the imaging. The low rate of complications during these early studies led to a
position statement by the European Society of Cardiology (ESC) in 2008 which
considered the risks of MRIs in selected patients with implanted devices
"acceptable" and set forth a protocol with careful selection criteria and best
practices for safely performing MRI studies in these patients.
The pacemakers and leads being investigated currently have approval for 3T MRI
scans in the EU. This study will also satisfy a PMCF requirement to maintain CE
mark for 3T MR Conditional labeling.
3T MRI examination differs from the standard treatment within the MCL.
Study objective
The objective of the study is to confirm the long-term safety of the Tendril
STS and Isoflex leads, implanted with the Assurity MRI* or Endurity MRI*
pacemakers, in patients undergoing clinically indicated 3T MRI scans.
Study design
This is a prospective, multicenter trial, single arm clinical investigation
designed to confirm the safety of SJM Tendril STS and Isoflex Optim leads,
together with the Assurity MRI or Endurity MRI pacemakers, in patients
undergoing 3T MRI scans.
Study burden and risks
All of the study procedures are part of standard-of-care, and would be done
even if the patient were not enrolled in the study. Only standard of care is a
1,5T MRI and in this study a 3T MRI is done, furthermore can the 1 month FU
visit be considered as additional study visit.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
Eligible subjects will meet all of the following:
* Are implanted with a St. Jude Medical Assurity MRI or Endurity MRI pacemaker
and Tendril STS 2088 or Isoflex 1944/1948 lead
* Capture threshold is stable and < 2.5V @ 0.5ms at the time of enrolment
* Are clinically indicated to undergo a 3T MRI scan
* Are willing and able to provide informed consent for study participation
(legal guardian is NOT acceptable).
* Are willing and able to comply with the prescribed follow-up tests and
schedule of evaluations.
Exclusion criteria
Subjects will be excluded if they meet any of the following:
* Are <18 years old (pediatric)
* Are currently participating in a clinical investigation that includes an
active treatment arm that may confound the results of this study as determined
by Abbott.
* Known pregnancy, intends to become pregnant, or the patient is nursing.
* Have a life expectancy of less than 12 months due to any condition
* Contraindications for having a MRI scan including the presence of metal
implants (e.g. stents, dental braces, pumps, hip or knee implants), abandoned
or capped leads, or other devices (e.g. DBS).
* Presence of other anatomic or comorbid conditions, or other medical, social,
or psychological conditions that, in the investigator*s opinion, could limit
the subject*s ability to participate in the clinical investigation or to comply
with follow-up requirements, or impact the scientific soundness of the clinical
investigation results
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 | NL68881.099.19 |