Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning
Public ClinicalTrials.gov record NCT07908927. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning (MAP)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
One of the most serious complications with leadless pacemaker (LP) implants is right ventricle (RV) perforation. Understanding the accuracy of fluoroscopic guidance of implants compared to transthoracic echocardiograms (TTE) and computed tomography angiography (CTA) of the heart will help guide future implant techniques. We hypothesize that TTE-guided implantation would lead to improved safety and accuracy of leadless pacemaker implants. The implanter and two independent electrophysiologists will estimate the location of the implant based on standard fluoroscopic views using RV site nomenclature after the procedure. Each participant will then undergo a TTE and have 3 independent assessments of the implant site. Within 48 hours of the implant, a CTA of the heart will then be performed with contrast, which will serve as the gold standard to determine the actual implant site. The primary endpoint will compare implanting electrophysiologist, fluoroscopy, and TTE predicted location of a new implanted Micra VR or AV2 leadless pacemaker to the implant location found on a gold standard CTA of the heart. The secondary endpoints will compare implant technique (Jugular vs. Femoral) by defining timing of implant procedure, repositioning, and accuracy of predicted implant location. The other secondary endpoints will compare baseline and demographic characteristics (BMI, COPD, LVEF, implant technique) to EKG parameters at final position, fluoroscopy and TTE image quality, acquisition of triangle or Koch and Bachmann area view during TTE.
Study identification
- NCT ID
- NCT07908927
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Other
- Enrollment
- 20 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 89 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 13, 2026 (Actual)
- Primary completion
- Mar 31, 2028 (Estimated)
- Completion
- May 31, 2028 (Estimated)
- Last update posted
- Nov 2, 2026
2026 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07908927, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2026 · Synced Nov 5, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07908927 live on ClinicalTrials.gov.