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RECRUITING
NCT05667519
NA

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

Sponsor: LMU Klinikum

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

324

Start Date

2022-10-01

Completion Date

2027-10

Last Updated

2022-12-28

Healthy Volunteers

No

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

Locations (1)

LMU Klinikum

Munich, Bavaria, Germany