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

Not Applicable

Recruiting

• Conditions: Tricuspid Regurgitation; Pacemaker Complication
• Interventions: Procedure: Additional guidance of lead implantation by transesophageal echocardiography

• Registration Number: NCT05667519
• Lead Sponsor: LMU Klinikum

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-19
• Last Update Submitted: 2022-12-19
• Study First Posted: 2022-12-28
• Last Update Posted: 2022-12-28
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 324

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transesophageal echocardiography + fluoroscopy guided lead implantation	Additional guidance of lead implantation by transesophageal echocardiography	TEE will be done in addition to fluoroscopy to guide lead implantation.

Primary Outcome Measures

Name	Time	Method
Worsening of tricuspid regurgitation by at least one grade	Mean follow up of 2 years	Worsening of tricuspid regurgitation by at least one grade on transthoracic echocardiography according to current guidelines

Secondary Outcome Measures

Name	Time	Method
Death and cardiovascular death	Mean follow up of 2 years	All cause death and cardiovascular death
Heart failure hospitalizations	Mean follow up of 2 years	Unplanned hospitalizations for heart failure
Duration of procedure and radiation	Mean follow up of 2 years	Standard parameters affecting quality of device implantation
Right ventricular function and geometry as assessed by transthoracic echocardiography	Mean follow up of 2 years	Right ventricular function (TAPSE, fractional area change, 3D volumetry) and geometry as assessed by transthoracic echocardiography
Sensing, Pacing and RV-stimulation of the right ventricular lead	Mean follow up of 2 years	Sensing, Pacing and RV-stimulation of the right ventricular lead in the pacemaker readout
Change in functional capacity as assessed NYHA classification	Mean follow up of 2 years	New York Heart Association (NYHA) Functional Classification
Change in quality of life as assessed by MLHFQ	Mean follow up of 2 years	Minnesota Living with Heart Failure Questionnaire

Trial Locations

Locations (1)

LMU Klinikum; 🇩🇪 Munich, Bavaria, Germany