Preventing tricuspid regurgitation during pacemaker lead implantation
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
This study is testing if using a special ultrasound during pacemaker lead placement can help prevent heart valve problems compared to just using X-rays.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LMU Klinikum Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT05667519 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two methods of guiding pacemaker lead implantation: one using transesophageal echocardiography combined with fluoroscopy, and the other using fluoroscopy alone. Patients will be randomly assigned to one of the two groups and monitored for up to three years to assess the incidence of lead-induced tricuspid regurgitation. The study aims to determine if the echocardiography-guided approach can reduce complications associated with pacemaker implantation. The primary endpoint will be evaluated by a blinded echocardiographer following established guidelines.
Who should consider this trial
Good fit: Ideal candidates are patients who require right ventricular lead implantation according to current medical guidelines.
Not a fit: Patients with preexisting tricuspid regurgitation of grade 2 or higher or other severe heart valve diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of tricuspid regurgitation and improve outcomes for patients undergoing pacemaker implantation.
How similar studies have performed: Previous studies have suggested that transesophageal echocardiography may reduce complications, but this is the first randomized controlled trial to directly compare these two methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * indication for right ventricular lead implantation according to current guidelines Exclusion Criteria: * preexisting tricuspid regurgitation ≥ grade 2 * other severe heart valve disease * history of tricuspid valve treatment * preexisting right ventricular lead * chronic dialysis * contraindication for transesophageal echocardiography
Where this trial is running
Munich, Bavaria
- LMU Klinikum — Munich, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Daniel Braun, MD — LMU Klinikum
- Study coordinator: Daniel Braun, MD
- Email: daniel.braun@med.uni-muenchen.de
- Phone: +4989440072371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.