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

LMU Klinikum

Status: Completed

Conditions: Pacemaker Complication; Echocardiography, Transesophageal; Tricuspid Valve Insufficiency

Treatments: Procedure: Transesophageal guidance of lead implantation

Study type: Observational

Funder types: Other

Identifiers

NCT04945005

101214

Details and patient eligibility

About

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.

Full 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

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

124 participants in 2 patient groups

Lead implantation with transesophageal echocardiography

Description:

All patients undergoing pacemaker/CRT implantation with concomitant transesophageal echocardiography in addition to fluoroscopic guidance

Treatment:

Procedure: Transesophageal guidance of lead implantation

Lead implantation without transesophageal echocardiography (retrospective)

Description:

All patients undergoing standard pacemaker/CRT implantation guided by fluoroscopy only (retrospective historical control group)