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

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.

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Regurgitation; Pacemaker Complication
• Intervention / Treatment: Procedure: Additional guidance of lead implantation by transesophageal echocardiography

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 Type: Interventional
• Enrollment (Anticipated): 324
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Braun, MD; Phone Number: +4989440072371; Email: daniel.braun@med.uni-muenchen.de
• Study Contact Backup: Name: Jonas Gmeiner, MD; Phone Number: +4989440072371; Email: jonas.gmeiner@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Recruiting
      • LMU Klinikum
      • Contact: Daniel Braun, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transesophageal echocardiography + fluoroscopy guided lead implantation; TEE will be done in addition to fluoroscopy to guide lead implantation.	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
No Intervention: Fluoroscopy guided lead implantation; Fluoroscopy only will be used to guide lead implantation.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	Freedom from esophageal injury, pericardial effusion and pneumothorax requiring intervention as well as lead infection/-displacement requiring lead revision	During hospital stay (up to day 7)

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Investigators: Principal Investigator: Daniel Braun, MD, LMU Klinikum

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): October 1, 2027
• Study Completion (Anticipated): October 1, 2027

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: PLACE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No