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Recruiting
NCT05667519
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
Conditions: Tricuspid Regurgitation, Pacemaker Complication
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 324
Sponsor: LMU Klinikum
Location: Germany
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.
Eligibility Criteria
Inclusion Criteria:indication for right ventricular lead implantation according to current guidelinesExclusion Criteria:preexisting tricuspid regurgitation ≥ grade 2other severe heart valve diseasehistory of tricuspid valve treatmentpreexisting right ventricular leadchronic dialysiscontraindication for transesophageal echocardiography
Source: ClinicalTrials.gov (NCT05667519). StuddyBuddy aggregates publicly available trial information.