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

Sponsor

LMU Klinikum (Other)

Overall Status

Completed

CT.gov ID

NCT04945005

Collaborator

(none)

124

Enrollment

Location

Actual Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Valve Insufficiency Pacemaker Complication Echocardiography, Transesophageal	Procedure: Transesophageal guidance of lead implantation

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

124 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2019

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Lead implantation with transesophageal echocardiography All patients undergoing pacemaker/CRT implantation with concomitant transesophageal echocardiography in addition to fluoroscopic guidance	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
Lead implantation without transesophageal echocardiography (retrospective) All patients undergoing standard pacemaker/CRT implantation guided by fluoroscopy only (retrospective historical control group)

Arm

Intervention/Treatment

Lead implantation with transesophageal echocardiography

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

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

Lead implantation without transesophageal echocardiography (retrospective)

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

Outcome Measures

Primary Outcome Measures

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

Dose-are product [Intraprocedural]
Dose-are product applied during lead implantation
Lead revisions [30 days]
Incidence of acute lead revisions within 30 days
Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4) [3 months]
Lead induced tricuspid regurgitation measured by transthoracic echocardiography
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LMU Klinikum	Munich	Bavaria	Germany	81377

Sponsors and Collaborators

LMU Klinikum

Investigators

Principal Investigator: Daniel Braun, PD Dr. med., LMU Klinikum

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daniel Braun, MD, Attending Physician, LMU Klinikum

ClinicalTrials.gov Identifier:

NCT04945005

Other Study ID Numbers:

101214

First Posted:

Jun 30, 2021

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Jun 30, 2021