Long 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

Long 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 - Brady 3T MRI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49741

Enrollment

Registered

2019-07-22

Start date

2019-10-04

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Subjects will be excluded if they meet any of the following: * Are

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Primary Endpoint #2: Proportion of subjects with a sensing amplitude decrease of * 50% from pre- MRI scan to one-month post MRI scan.	—

Countries

Netherlands

Outcome results