NCT04945005

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 124 (actual)
• Sponsor: LMU Klinikum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tricuspid Valve Insufficiency
• Pacemaker Complication
• Echocardiography, Transesophageal

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2021-06-30
• Last updated: 2021-06-30

Locations

1 site across 1 country: Germany