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

Recruiting now · Not applicable

Conditions studied: Tricuspid Regurgitation, Pacemaker Complication

In brief

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.

Key facts

Study ID

NCT05667519

Run by

LMU Klinikum

People needed

324

Starts

2022-10-01

Expected to finish

2027-10-01

Last updated by the study team

2022-12-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• indication for right ventricular lead implantation according to current guidelines

You may not qualify if…

• 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

Where it is running

• LMU Klinikum — Munich, Bavaria, Germany (enrolling)

Full record on ClinicalTrials.gov

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