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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Echocardiography, Transesophageal
• Pacemaker Complication
• Tricuspid Valve Insufficiency

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