An interventional study of Cardiac Imaging by TTE or CTA in Sinus Pause, Sinus Sick Syndrome and Heart Block, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Not applicable, Interventional, and Diagnostic
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.
93 studies on the registry are indexed under Sick Sinus Syndrome; 18 are open to participants now.
This study's planned enrollment of 20 is below the median of 137 across 62 interventional studies indexed under Sick Sinus Syndrome.
Browse Sick Sinus Syndrome studies →Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) is the lead sponsor of 49 studies on the registry; 20 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients undergoing a new Micra VR or AV2 leadless pacemaker implant will be considered for recruitment. After the consent and screening processes, eligible participants will undergo their standard-care implantation procedure according to clinical guidelines. After the implantation procedure is complete, the study investigation will start when the participant undergoes a TTE and CTA imaging of the heart.
Diagnostic Test: Cardiac Imaging by TTE or CTA
After a standard care pacemaker implantation, participants will undergo two standard care imaging procedures which will be compared.
Assess accuracy predicted implant locations to CTA
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 modality, CTA of the heart. \[measure: location accuracy\]
Time frame: 3 months
Implant technique timing
Compare time required for Jugular vs. Femoral implant techniques \[measure: minutes}
Time frame: 1 hour
Implant technique repositioning
Compare Jugular vs. Femoral implant techniques by defining repositioning attempts \[measure: number of attempts\]
Time frame: 1 hour
Implant technique prediction accuracy
Compare Jugular vs. Femoral implant techniques by defining the accuracy of predicted implant location \[measure: percentage\]
Time frame: 1 hour
Baseline characteristics
Compare baseline 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 \[measure: scale 1-5\]
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Mar 2028, 22 months after the start.
Of 22 interventional studies with no phase under Sick Sinus Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 47. This study's planned 22 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)