Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)

Launched by LMU KLINIKUM · Dec 19, 2022

Keywords

ClinConnect Summary

The PLACE trial is studying a new method for placing pacemaker leads to see if it can help prevent a heart condition called tricuspid regurgitation, which occurs when the heart's tricuspid valve doesn't close properly. In this trial, participants will be randomly assigned to receive either the standard lead placement method using a type of imaging called fluoroscopy or a new method that also uses a special ultrasound technique called transesophageal echocardiography to guide the procedure. The goal is to find out if the new method is more effective in preventing complications related to pacemaker leads.

To be eligible for the trial, participants should need a right ventricular lead implanted, which is a common requirement for certain heart conditions. However, those with existing moderate to severe tricuspid regurgitation or other serious heart valve issues, as well as individuals on chronic dialysis or who cannot undergo the ultrasound procedure, will not be eligible. Participants in the trial can expect to be monitored for up to three years to assess their heart health and any complications related to the pacemaker leads. This research is important for improving care and outcomes for patients needing pacemaker implants.

Gender

ALL

Eligibility 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