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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04945005

Acronym

PLACE

Enrollment

124

Registered

2021-06-30

Start date

2019-11-01

Completion date

2020-12-31

Last updated

2021-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Echocardiography, Transesophageal, Pacemaker Complication, Tricuspid Valve Insufficiency

Brief summary

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.

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

Interventions

PROCEDURETransesophageal 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* pre-existing RV lead * pre-existing TR \>2

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026