Announcing Dr. Moretta’s Participation in Conduction System Pacing Study
In the spirit of bringing to you the latest news in electrophysiology and our practice, Dr. Moretta is thrilled to have been chosen as a study center for the BIOTRONIK Conduction System Pacing with the Solia Lead clinical trial. Our program was the third facility, after NYU and Cornell University, to be asked to participate in this trial.
As you may know, Dr. Moretta is a proponent of conduction system pacing and a leader in its adoption. It offers potentially significant benefits over traditional pacemakers, and this study will help solidify research into those advantages. Left Bundle Branch (LBB) pacing is a particularly exciting research focus in this area.
There are two primary outcomes that we are looking to measure in this study:
- First is measuring the number of serious adverse effects, free implants three months after the procedure.
- The second is the success rate of the implant at the time of the procedure.
Several secondary outcome measures will include quality of life measurements after 12 months and the serious adverse effects-free rate at six months and one year. There are about a dozen secondary outcome measures in total.
Who May Be Appropriate for the Clinical Study?
We are enrolling for this clinical trial, with a primary completion date estimated to be September 1. We expect a total of 260 participants. The study completion dates, including most, if not all, measures, will be mid-year 2024.
Some of the inclusion criteria include the following:
- Being 18 years or older
- Being a candidate for this pacing system
- Giving your consent for home monitoring
- And being available for follow-up visits during the study.
There Are Other Inclusion Criteria to Be Discussed
Some, but not all, of the exclusion criteria include:
- Contraindications to pacemaker systems
- Having a pacemaker or ICD currently implanted
- Having previous failed attempts at conduction
- and more…
We encourage you to contact our office to see if you may be a candidate for this trial. Even if conduction system pacing and/or this study is not the right option, we have several options for patients with bradycardia or a slow heartbeat, including traditional pacemakers and implantable leadless pacing systems.