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NCT04945005 Clinical Trial

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

Tricuspid Valve Insufficiency Clinical Trial

— PLACE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04945005
Other study ID # 101214
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 31, 2020

Study information
Verified date June 2021
Source LMU Klinikum
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 124
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany LMU Klinikum Munich Bavaria

Sponsors (1)
Lead Sponsor Collaborator
LMU Klinikum

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Dose-are product Dose-are product applied during lead implantation Intraprocedural
Secondary Lead revisions Incidence of acute lead revisions within 30 days 30 days
Secondary 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
Secondary 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
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