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

Last updated: December 19, 2022
Sponsor: LMU Klinikum
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT05667519
PLACE
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • indication for right ventricular lead implantation according to current guidelines

Exclusion

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

Study Design

Total Participants: 324
Study Start date:
October 01, 2022
Estimated Completion Date:
October 31, 2027

Study 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.

Connect with a study center

  • LMU Klinikum

    Munich, Bavaria 81377
    Germany

    Active - Recruiting

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