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

Tricuspid Regurgitation Clinical Trial

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

Clinical Trial Summary

This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years.

Clinical Trial Description

Lead-induced tricuspid regurgitation is a frequent complication after pacemaker- and ICD-implantation that is associated with increased mortality and hospitalizations for heart failure. Transesophageal echocardiography has shown to be a safe and feasible way to guide right ventricular lead placement and was associated with less worsening of tricuspid regurgitation than standard lead implantation in a small study with a retrospective control group. This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years. Echocardiographic grading of the primary endpoint will be performed by a blinded echocardiographer according to current guidelines. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05667519
Study type Interventional
Source LMU Klinikum
Contact Daniel Braun, MD
Phone +4989440072371
Email daniel.braun@med.uni-muenchen.de
Status Recruiting
Phase N/A
Start date October 1, 2022
Completion date October 2027
View Details
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