PacemakerMicraNCT04051814
A Retrospective Trial to Evaluate the Micra Pacemaker
An observational study of Pacemaker, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
Trial summary
This is a retrospective study of our patient population implanted with the Medtronic's Leadless single-chamber ventricular pacemakers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker
- What is being tested?
- Micra Transcatheter Pacemaker System
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2019to 15 May 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Patients scheduled to be implanted with a leadless pacemaker
Who may be able to join
- All Patients scheduled to be implanted with a leadless pacemaker
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Leila Andres, MS, 949-764-4510, clinicalresearch@hoag.org
About this study
This is a retrospective study of our patient population implanted with the Medtronic's Leadless single-chamber ventricular pacemakers.
Read the 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:
- What are the peri-procedural and post-procedural complications of leadless pacemakers?
- What are the long-term outcomes of leadless pacemakers?
- 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:
- What are the peri-procedural and post-procedural complications, and long term outcomes of leadless pacemakers?
- Are leadless pacemakers equivalent or superior to conventional pacemaker's in general clinical practice?
- What are the infection rates, the long-term hemodynamic effects, and the rates of formation of thrombi?
- What are the patient demographics and effects of patient characteristics (age, gender, comorbidities) on the use and health effects of leadless pacemakers?
- 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)?
- How are operators and facility characteristics related to peri-procedural and post-procedural complications?
- Conditions
- Pacemaker
- Being tested
- Micra Transcatheter Pacemaker System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micra Transcatheter Pacemaker SystemOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rate
We plan to collect data to determine the acute overall complication rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start31 Jul 2019
- Primary completion15 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Balius, Hoag Memorial Hospital Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051814
- Sponsor's protocol ID
- 191-18-CV
- Acronym
- Micra
- Status last verified
- Feb 2023
- First submitted
- 8 Aug 2019
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Trial to Evaluate the Micra Pacemaker
- ClinicalTrials.gov ID
- NCT04051814
- Acronym / sponsor ID
- Micra / 191-18-CV
- Conditions
- Pacemaker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective study of our patient population implanted with the Medtronic's Leadless single-chamber ventricular pacemakers.
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:
- What are the peri-procedural and post-procedural complications of leadless pacemakers?
- What are the long-term outcomes of leadless pacemakers?
- 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:
- What are the peri-procedural and post-procedural complications, and long term outcomes of leadless pacemakers?
- Are leadless pacemakers equivalent or superior to conventional pacemaker's in general clinical practice?
- What are the infection rates, the long-term hemodynamic effects, and the rates of formation of thrombi?
- What are the patient demographics and effects of patient characteristics (age, gender, comorbidities) on the use and health effects of leadless pacemakers?
- 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)?
- How are operators and facility characteristics related to peri-procedural and post-procedural complications?
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Patients scheduled to be implanted with a leadless pacemaker
Key inclusion criteria (1 listed)
- All Patients scheduled to be implanted with a leadless pacemaker
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micra Transcatheter Pacemaker SystemA 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 | Other | – |
Primary outcome
Complication Rate
Time frame: 2 years
We plan to collect data to determine the acute overall complication rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leila Andres, MS (949-764-4510, clinicalresearch@hoag.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.