A Retrospective Trial to Evaluate the Micra Pacemaker

Sponsor
Hoag Memorial Hospital Presbyterian (Other)
Overall Status
Recruiting
CT.gov ID
NCT04051814
Collaborator
(none)
500
1
69.5
7.2

Study Details

Study Description

Brief Summary

This is a retrospective study of our patient population implanted with the Medtronic's Leadless single-chamber ventricular pacemakers.

Condition or Disease Intervention/Treatment Phase
  • Other: Micra Transcatheter Pacemaker System

Detailed Description

This protocol outlines the methods on the Micra Pacemaker. The Micra Transcatheter Pacemaker 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 device eliminates the need for a device pocket and insertion of a pacing lead, thereby eliminating lead and pocket related complications associated with traditional pacing systems while providing similar pacing benefits. The US Food and Drug Administration (FDA) approved the Micra system on April 6, 2016, for the following conditions:

  • symptomatic paroxysmal or permanent high-grade atrioventricular block (AV) in the presence of atrial fibrillation (AF)

  • symptomatic paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy

  • symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy The FDA approved the Micra system on the basis of clinical trial evidence from the Micra Investigational Device Exemption (IDE) study (NCT02488681).

On January 18, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a final National Coverage Determination (NCD) on leadless pacemakers, providing for coverage with Coverage with Evidence Development (CED) of approved leadless pacemakers for approved indications (CAG-00448N). The NCD requires the research study conducted as part of CED to address the following research questions:

  1. What are the peri-procedural and post-procedural complications of leadless pacemakers?

  2. What are the long-term outcomes of leadless pacemakers?

  3. What are the effects of patient characteristics (age, gender, comorbidities) on the use and health effects of leadless pacemakers?

In addition, CMS outlined six evidentiary gaps in the final NCD for leadless pacemakers:
  1. What are the peri-procedural and post-procedural complications, and long term outcomes of leadless pacemakers?

  2. Are leadless pacemakers equivalent or superior to conventional pacemaker's in general clinical practice?

  3. What are the infection rates, the long-term hemodynamic effects, and the rates of formation of thrombi?

  4. What are the patient demographics and effects of patient characteristics (age, gender, comorbidities) on the use and health effects of leadless pacemakers?

  5. What are the device-related issues (handling of end of battery life; effects of having multiple leadless pacemakers implanted; rate of device dislodgement; and the possibility of device extractions)?

  6. How are operators and facility characteristics related to peri-procedural and post-procedural complications?

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
A Retrospective Trial to Evaluate the Micra Pacemaker
Actual Study Start Date :
Jul 31, 2019
Anticipated Primary Completion Date :
May 15, 2025
Anticipated Study Completion Date :
May 15, 2025

Outcome Measures

Primary Outcome Measures

  1. Complication Rate [2 years]

    We plan to collect data to determine the acute overall complication rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All Patients scheduled to be implanted with a leadless pacemaker
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hoag Memorial Hospital Presbyterian Newport Beach California United States 92663

Sponsors and Collaborators

  • Hoag Memorial Hospital Presbyterian

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Colleen Balius, Clinical Data Coordinator, Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier:
NCT04051814
Other Study ID Numbers:
  • 191-18-CV
First Posted:
Aug 9, 2019
Last Update Posted:
Aug 25, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 25, 2021