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

Completed

• Conditions: Echocardiography, Transesophageal; Tricuspid Valve Insufficiency; Pacemaker Complication
• Interventions: Procedure: Transesophageal guidance of lead implantation

• Registration Number: NCT04945005
• Lead Sponsor: LMU Klinikum

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

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-21
• Last Update Submitted: 2021-06-21
• Study First Posted: 2021-06-30
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lead implantation with transesophageal echocardiography	Transesophageal guidance of lead implantation	All patients undergoing pacemaker/CRT implantation with concomitant transesophageal echocardiography in addition to fluoroscopic guidance

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

LMU Klinikum; 🇩🇪 Munich, Bavaria, Germany