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Completed

NCT Number: NCT04945005

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

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.

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Key information

Conditions

Tricuspid Valve Insufficiency Cardiovascular Diseases Echocardiography, Transesophageal Heart Diseases Heart Valve Diseases Pacemaker Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LMU Klinikum

Munich, Bavaria, 81377, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • indication for pacemaker/ICD implantation including a transtricuspid lead according to guidelines

Exclusion criteria

  • pre-existing RV lead
  • pre-existing TR >2

Treatment and study plan

Transesophageal guidance of lead implantation

Procedure

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

Primary outcomes

  1. Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)

    Time frame: 2 - 7 days post-implant (at hospital discharge)

    Lead induced tricuspid regurgitation measured by transthoracic echocardiography

Secondary outcomes

  1. Dose-are product

    Time frame: Intraprocedural

    Dose-are product applied during lead implantation

  2. Lead revisions

    Time frame: 30 days

    Incidence of acute lead revisions within 30 days

  3. Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)

    Time frame: 3 months

    Lead induced tricuspid regurgitation measured by transthoracic echocardiography

  4. Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)

    Time frame: 12 months

    Lead induced tricuspid regurgitation measured by transthoracic echocardiography

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Acronym: PLACE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 30, 2021
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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