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

Registry for patients undergoing pacemaker/ICD implantation including a transtricuspid lead with and without intraprocedural transesophageal echocardiography to evaluate risk factors for lead induced tricuspid regurgitation.

Study Overview

• Status: Completed
• Conditions: Tricuspid Valve Insufficiency; Echocardiography, Transesophageal; Pacemaker Complication
• Intervention / Treatment: Procedure: Transesophageal guidance of lead implantation

Detailed Description

Lead induced tricuspid regurgitation is a common finding after pacemaker/ICD Implantation. Transesophageal echocardiography (TEE) might be used to guide lead implantations in order to prevent tricuspid regurgitation.

In this registry, patients undergoing pacemaker/ICD implantation including a transtricuspid lead are enrolled. While in most patients lead implantation is guided by fluroscopy, in some patients lead implantation is guided by TEE in addition to fluroscopy.

Aims of this registry: Evaluation of

• Incidence of lead induced tricuspid regurgitation
• Mortality and morbidity of lead induced tricuspid regurgitation
• Identification of risk factors for lead induced tricuspid regurgitation
• Influence of the lead position within the tricuspid valve on the incidence of lead induced tricuspid regurgitation
• Prevention of lead induced tricuspid regurgitation by TEE-guided lead implantation

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • LMU Klinikum

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All adult patients undergoing pacemaker/ICD implantation including a transtricuspid lead were included in this registry.

Description

Inclusion Criteria:

• indication for pacemaker/ICD implantation including a transtricuspid lead according to guidelines

Exclusion Criteria:

• pre-existing RV lead
• pre-existing TR >2

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lead implantation with transesophageal echocardiography; All patients undergoing pacemaker/CRT implantation with concomitant transesophageal echocardiography in addition to fluoroscopic guidance	Procedure: Transesophageal guidance of lead implantation; In patients undergoing lead implantation including transesophageal echocardiography for clinical reasons (e.g. intraprocedural cardioversion), echocardiography was also used for guidance of lead implantation to reduce lead-leaflet interactions
Lead implantation without transesophageal echocardiography (retrospective); All patients undergoing standard pacemaker/CRT implantation guided by fluoroscopy only (retrospective historical control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)	Lead induced tricuspid regurgitation measured by transthoracic echocardiography	2 - 7 days post-implant (at hospital discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-are product	Dose-are product applied during lead implantation	Intraprocedural
Lead revisions	Incidence of acute lead revisions within 30 days	30 days
Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)	Lead induced tricuspid regurgitation measured by transthoracic echocardiography	3 months
Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)	Lead induced tricuspid regurgitation measured by transthoracic echocardiography	12 months

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Investigators: Principal Investigator: Daniel Braun, PD Dr. med., LMU Klinikum

Publications and helpful links

General Publications

• Gmeiner J, Sadoni S, Orban M, Fichtner S, Estner H, Massberg S, Hagl C, Nabauer M, Hausleiter J, Braun D. Prevention of Pacemaker Lead-Induced Tricuspid Regurgitation by Transesophageal Echocardiography Guided Implantation. JACC Cardiovasc Interv. 2021 Dec 13;14(23):2636-2638. doi: 10.1016/j.jcin.2021.08.042. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

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: 101214

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