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

LMU Klinikum

Status: Enrolling

Conditions: Pacemaker Complication; Tricuspid Regurgitation

Treatments: Procedure: Additional guidance of lead implantation by transesophageal echocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT05667519

PLACE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 324 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• indication for right ventricular lead implantation according to current guidelines

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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324 participants in 2 patient groups

Transesophageal echocardiography + fluoroscopy guided lead implantation

Experimental group

Description:

TEE will be done in addition to fluoroscopy to guide lead implantation.

Treatment:

Procedure: Additional guidance of lead implantation by transesophageal echocardiography

Fluoroscopy guided lead implantation

No Intervention group

Description:

Fluoroscopy only will be used to guide lead implantation.