MRI STUDY ACCENT MRI* PACEMAKER AND TENDRIL MRI* LEAD IDE STUDY

Completed

Conditions: MRI safety Accent MRI systeem
MRI onderzoek bij patienten met een pacemaker
10007521

Registration Number: NL-OMON37204

Lead Sponsor: St. Jude Medical

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Eligible patients will meet all of the following:
1. Have an approved indication per ACC/AHA/HRS guidelines for implantation of a pacemaker
2. Wil receive a pacemaker systeem
3. Be willing to undergo an elective MRI scan without sedation
4. Be able to provide informed consent for study participation
5. Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
6. Is not contraindicated for an MRI scan

Exclusion Criteria

Patients will be excluded if they meet any of the following:
1. Have an existing pacemaker or ICD. A new pacemaker and lead is required for enrollment
2. Have an existing active/inactive implanted medical device
3. Have a non-MRI compatible device or material implanted
4. Have a lead extender or adaptor
5. Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore.
6. Have a prosthetic tricuspid heart valve
7. Are currently participating in a clinical investigation that includes an active treatment arm
8. Are allergic to dexamethasone sodium phosphate (DSP)
9. Are pregnant or planning to become pregnant during the duration of the study
10. Have a life expectancy of less than 12 months due to any condition
11. Patients with exclusion criteria required by local law (e.g., age)
12. Are unable to comply with the follow up schedule

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>Safety of the Tendril MRI* lead will be evaluated in terms of freedom from RA<br /><br>and RV lead-related complications for the acute (implant to 2 month visit) and<br /><br>chronic (2 month visit through the 12 month visit) timeframes.<br /><br>The safety of the Accent MRI system will be evaluated in terms of freedom from<br /><br>MRI scan related complications in the month following the MRI scan.<br /><br><br /><br>Efficacy<br /><br>Efficacy of the Tendril MRI* lead will be evaluated in terms of the change in<br /><br>atrial and ventricular capture and sensing thresholds before and after the MRI<br /><br>scan.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>Safety of the Accent MRITM system will be evaluated in terms of freedom from<br /><br>system-related complications through the 12 month visit.<br /><br><br /><br>Efficacy<br /><br>Efficacy of the Tendril MRI* lead will be evaluated in terms of the atrial and<br /><br>ventricular capture thresholds at the MRI Visit.</p><br>