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Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning
Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning (MAP)
Who can join
Ages 18 to 89 · All sexes
Full eligibility criteria
Inclusion Criteria: * Male and female patients aged 18-89, inclusive. * All patients undergoing implant of a new Micra VR or AV2 leadless pacemaker. Exclusion Criteria: * Women who are pregnant or breastfeeding * Existing device implant * Breast or Pectoral Implants * Patients with a GFR less than 45, unless the patient is on dialysis (in which case, may be included) * Known allergy to iodinated contrast. * Any other condition or finding that, in the opinion of the investigator, would contraindicate participation.
About the study
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.
What is being tested
- Cardiac Imaging by TTE or CTA (diagnostic test)
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Participants: 20 · Started: May 13, 2026
Contact the study team
- Caitlin Phalunas, MSBME · Phone: 412-359-3747
- Joshua Silverstein, MD · Phone: 412-359-3457
Official record on ClinicalTrials.gov — NCT07908927
Locations in the U.S.
| Pennsylvania | Allegheny Health Network, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.