Can fluoroscopy plus TTE guidance improve leadless pacemaker placement accuracy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing a new Micra VR or AV2 leadless pacemaker implantation will have their implant site predicted by the implanter and two independent electrophysiologists using fluoroscopy. Each participant will then have a TTE and three independent assessments of the implant site, followed within 48 hours by a contrast-enhanced CTA which serves as the reference standard to determine the true location. The primary endpoint compares the predicted implant site from the implanting electrophysiologist, fluoroscopy, and TTE against the CTA gold standard. Interventions focus on cardiac imaging using TTE or CTA to inform implant placement. The study aims to assess whether TTE-guided implantation can improve placement accuracy and safety, particularly regarding the risk of right ventricular perforation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Allegheny Health Network
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Caitlin Phalunas, MSBME
• Email: caitlin.phalunas@ahn.org
• Phone: 412-359-3747

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.