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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tricuspid Regurgitation, Pacemaker Complication

Intervention / Treatment
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* Procedure: Additional guidance of lead implantation by transesophageal echocardiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transesophageal echocardiography + fluoroscopy guided lead implantation<br>TEE will be done in addition to fluoroscopy to guide lead implantation. | Procedure: Additional guidance of lead implantation by transesophageal echocardiography<br>* 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<br>|
| No Intervention: Fluoroscopy guided lead implantation<br>Fluoroscopy only will be used to guide lead implantation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worsening of tricuspid regurgitation by at least one grade | Worsening of tricuspid regurgitation by at least one grade on transthoracic echocardiography according to current guidelines | Mean follow up of 2 years | 

Secondary Outcome Measures

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