Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2019-07-31
2025-05-15
Brief Summary
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Detailed Description
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* 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?
Conditions
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Study Design
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COHORT
OTHER
Interventions
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Micra Transcatheter Pacemaker System
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hoag Memorial Hospital Presbyterian
OTHER
Responsible Party
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Colleen Balius
Clinical Data Coordinator
Locations
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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191-18-CV
Identifier Type: -
Identifier Source: org_study_id
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