ong term follow-up of the Tendril STS and Isoflex leads in conjunction with the Assurity MRI* and Endurity MRI* Pacemakers within the 3T MRI Environment

Completed

Conditions: veiligheidsonderzoek in het kader van PMCF van MRI compatibele pacemaker in combinatie met 3T MRI
cardiac rythme disorders
10007521

Registration Number: NL-OMON49741

Lead Sponsor: Abbott Medical Nederland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint#1: Proportion of subjects with a capture threshold increase of<br /><br>* 0.5V at the permanently programmed pulse width from pre- MRI scan to<br /><br>one-month post MRI scan. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Primary Endpoint #2: Proportion of subjects with a sensing amplitude decrease<br /><br>of * 50% from pre- MRI scan to one-month post MRI scan. </p><br>