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

NCT05667519 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2022-12-28

No results posted yet for this study

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.

Conditions

  • Tricuspid Regurgitation
  • Pacemaker Complication

Interventions

PROCEDURE

Additional guidance of lead implantation by transesophageal echocardiography

Transesophageal echocardiography guidance of lead implantation targeting a stable lead position in a tricuspid valve commissure (preferentially postero-septal) and an apical ventricular lead position

Sponsors & Collaborators

  • LMU Klinikum

    lead OTHER

Principal Investigators

  • Daniel Braun, MD · LMU Klinikum

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05667519 on ClinicalTrials.gov