Recruiting

TTE & CTA

Sponsor:

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Code:

NCT07908927

Conditions

Sinus Pause

Sinus Sick Syndrome

Heart Block

Arrhythmias, Cardiac

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cardiac Imaging by TTE or CTA

Study Details

Brief summary:

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.

Conditions

Sinus Pause

Sinus Sick Syndrome

Heart Block

Arrhythmias, Cardiac

Study ID

NCT07908927

Start date

May 13, 2026

Status verified date

Jan, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Investigational

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.

Interventions

Cardiac Imaging by TTE or CTA

After a standard care pacemaker implantation, participants will undergo two standard care imaging procedures which will be compared.

Primary outcome measure

  • Assess accuracy predicted implant locations to CTA [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Caitlin Phalunas, MSBME

412-359-3747caitlin.phalunas@ahn.org

Joshua Silverstein, MD

412-359-3457Joshua.Silverstein@ahn.org

Locations

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Heather McDonald, MHA

412-359-3660heather.mcdonald@ahn.org

Principal Investigator:

Joshua Silverstein, MD

More Information

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Last update posted

Nov 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.