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Micra AV Transcatheter Pacing System Post-Approval Registry (Micra AV PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253184
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic

Brief Summary:

Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release.

The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.


Condition or disease Intervention/treatment
Bradycardia Drug: Micra AV Transcatheter Pacing System

Detailed Description:

The Micra AV Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra AV Registry will be prospectively followed for a minimum of 3 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent).

Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra AV system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's routine clinical care practice, those visits are reported. The total estimated registry duration is 4.5 years

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Micra AV Transcatheter Pacing System Post-Approval Registry
Actual Study Start Date : February 8, 2020
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Intervention Details:
  • Drug: Micra AV Transcatheter Pacing System
    The Micra AV Transcatheter Pacing System (TPS) is a miniaturized single chamber pacemaker that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart to provide bipolar sensing and pacing. The Micra AV system provides a form of VDD pacing that is based on mechanical atrial sensing utilizing a 3-axis accelerometer.


Primary Outcome Measures :
  1. Rate of pacemaker syndrome [ Time Frame: 3 years ]
    To characterize the rate of pacemaker syndrome resulting in a system revision at 3-years post-implant.


Secondary Outcome Measures :
  1. Acute complication rate [ Time Frame: 30 days ]
    To estimate the acute major complication rate related to the Micra AV system and/or procedure.

  2. Long-term complication rate [ Time Frame: 3 years ]
    To estimate the 3-year major complication rate related to the Micra AV system and/or procedure.


Other Outcome Measures:
  1. AV Synchrony Loss [ Time Frame: 3 years ]
    To characterize the rate and severity of adverse events potentially related to AV synchrony loss

  2. System and Procedure Releated AEs [ Time Frame: 3 years ]
    Summarize Micra AV system or procedure related adverse events

  3. Implant Characteristics [ Time Frame: Up to 3 years ]
    Characterize the implant procedure

  4. Electrical Performance [ Time Frame: 3 years ]
    Characterize electrical performance over time

  5. A4 Amplitude [ Time Frame: 3 years ]
    Characterize A4 amplitude over time



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients intended to be implanted with a Micra AV 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 AV system will be followed for a minimum of 3 years, unless a patient is exited from the registry due to an unavoidable reason such as death, physician discretion, or patient withdrawal of consent. If a Micra AV system is not successfully implanted, patients will be exited from the registry unless a Micra AV 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.

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 AV Transcatheter Pacing System and must be enrolled prior to the 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253184


Contacts
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Contact: Micra AV Registry Manager 763-526-0000 rs.productsurveillanceregistry@medtronic.com

Locations
Show Show 39 study locations
Sponsors and Collaborators
Medtronic
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT04253184    
Other Study ID Numbers: Micra AV PAS
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes