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Micra Transcatheter Pacing System Post-Approval Registry

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ClinicalTrials.gov Identifier: NCT02536118
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic

Tracking Information
First Submitted Date August 17, 2015
First Posted Date August 31, 2015
Last Update Posted Date January 18, 2019
Actual Study Start Date July 2015
Estimated Primary Completion Date August 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 16, 2017)
  • Acute complication rate [ Time Frame: 30-days ]
    To estimate acute complication rate related to the Micra system and/or implant procedure.
  • Long-term complication free survival [ Time Frame: 9 years ]
    To estimate the chronic complication free survival rate of the Micra system.
Original Primary Outcome Measures
 (submitted: August 26, 2015)
  • Acute complication rate [ Time Frame: 30-days ]
    The secondary objectives are descriptive in nature and are intended to gain additional information about the performance of the Micra System. There are no minimum sample size requirements for these objectives. To estimate acute complication rate related to the Micra system and/or implant procedure.
  • Long-term complication free survival [ Time Frame: 5 years ]
    To estimate the 5-year complication free survival rate of the Micra system.
Change History Complete list of historical versions of study NCT02536118 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 16, 2017)
  • Pacing impedance (ohms) and pacing threshold (volts) [ Time Frame: Up to 9 years ]
    Summary statistics of electrical performance 5-years post-implant measurements will be reported.
  • Complications stratified by implant type [ Time Frame: Up to 9 years ]
    A listing of Micra system and/or implant procedure related complications stratified by implant types including de novo implants, previous cardiac device, or co-existing hardware. The listing will include complications will be listed including device implant date, complication category, complication date, device-relatedness and seriousness.
  • Estimate Micra System revision rate [ Time Frame: Up to 9 years ]
    Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported.
  • Estimate System Longevity [ Time Frame: Up to 9 years ]
    Summary statistics regarding battery length will be reported.
  • Confirm the rate response operation of the Micra system [ Time Frame: Approximately 2 years ]
    Analysis of treadmill testing data from patients implanted with Micra for at least 3 months. Rate response data collected in the registry will be combined with data from the FDA Investigational Device Exemption study (NCT 02004873).
Original Secondary Outcome Measures
 (submitted: August 26, 2015)
  • Pacing impedance (ohms) and pacing threshold (volts) [ Time Frame: Up to 5 years ]
    Summary statistics of electrical performance 5-years post-implant measurements will be reported.
  • Complications stratified by implant type [ Time Frame: Up to 5 years ]
    A listing of Micra system and/or implant procedure related complications stratified by implant types including de novo implants, previous cardiac device, or co-existing hardware. The listing will include complications will be listed including device implant date, complication category, complication date, device-relatedness and seriousness.
  • Estimate Micra System revision rate [ Time Frame: Up to 5 years ]
    Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported.
  • Estimate System Longevity [ Time Frame: Up to 5 years ]
    Summary statistics regarding battery length will be reported.
Current Other Pre-specified Outcome Measures
 (submitted: January 25, 2017)
Micra System complications, pacing impedance (ohms) and pacing threshold (volts), following exposure to MR environment [ Time Frame: Up to 9 years ]
Micra System performance will be described following use in an MR environment. A listing of MRI related events, pacing impedance (ohms) and pacing threshold (volts) over time following MR exposure may be reported.
Original Other Pre-specified Outcome Measures
 (submitted: August 26, 2015)
Micra System complications, pacing impedance (ohms) and pacing threshold (volts), following exposure to MR environment [ Time Frame: Up to 5 years ]
Micra System performance will be described following use in an MR environment. A listing of MRI related events, pacing impedance (ohms) and pacing threshold (volts) over time following MR exposure may be reported.
 
Descriptive Information
Brief Title Micra Transcatheter Pacing System Post-Approval Registry
Official Title Micra Transcatheter Pacing System Post-Approval Registry
Brief Summary

Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release.

The Micra Registry is conducted within Medtronic's Product Surveillance Registry.

Detailed Description

The Micra Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent), or unless patient is participating in an acute performance sub-study of the Micra Registry*.

Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's standard care practice, those visits are reported. The total estimated registry duration is 11 years.

*Patients contributing to an acute performance sub-study of the Micra Registry do not contribute to the FDA-regulated Post-Approval Study which includes a long-term (minimum 9-year) patient follow-up period.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 9 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Patients intended to be implanted with a Micra system are eligible for enrollment and all patients must be consented prior to the Micra system implant. As such, only geographies with regulatory approval for the Micra system are eligible to enroll patients (see locations section).

All patients enrolled and successfully implanted with a Micra system will be followed for a minimum of 9 years, unless a patient is exited from the registry due to an unavoidable reason such as death, physician discretion, or patient withdrawal of consent, or unless the patient is participating in an acute performance sub-study of the Micra Registry. If a Micra system is not successfully implanted, patients will be exited from the registry unless a Micra System and/or implant procedure related event is identified, for which the patient will be followed until the event is resolved or no further actions need to be taken.

Condition Bradycardia
Intervention Device: Micra Transcatheter Pacing System
The Micra system is a miniaturized single chamber pacemaker system that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart. The Micra implantable device is a self-contained, hermetically enclosed, miniaturized single chamber pacemaker. The device is fixated via four electrically inactive nitinol tines, located on the distal end of the device.
Other Names:
  • Micra
  • Micra TPS
Study Groups/Cohorts Patients implanted with Micra System
Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.
Intervention: Device: Micra Transcatheter Pacing System
Publications * El-Chami MF, Al-Samadi F, Clementy N, Garweg C, Martinez-Sande JL, Piccini JP, Iacopino S, Lloyd M, Viñolas Prat X, Jacobsen MD, Ritter P, Johansen JB, Tondo C, Liu F, Fagan DH, Eakley AK, Roberts PR. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm. 2018 Dec;15(12):1800-1807. doi: 10.1016/j.hrthm.2018.08.005. Epub 2018 Aug 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 22, 2018)
3100
Original Estimated Enrollment
 (submitted: August 26, 2015)
1440
Estimated Study Completion Date August 2026
Estimated Primary Completion Date August 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient is intended to receive or be treated with a Micra Transcatheter Pacing System and must be enrolled prior to the TPS implant procedure

Exclusion Criteria:

  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Micra Registry Manager rs.productsurveillanceregistry@medtronic.com
Listed Location Countries Belgium,   Canada,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Iceland,   Israel,   Italy,   Japan,   Kuwait,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Saudi Arabia,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Russian Federation,   Slovenia,   United Arab Emirates
 
Administrative Information
NCT Number NCT02536118
Other Study ID Numbers Micra Registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medtronic
Study Sponsor Medtronic
Collaborators Not Provided
Investigators
Study Director: Micra Registry Manager Medtronic
PRS Account Medtronic
Verification Date January 2019