MedDataX Logo

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

NCT ID: NCT04945005

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tricuspid Valve Insufficiency Pacemaker Complication Echocardiography, Transesophageal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lead implantation with transesophageal echocardiography

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

Transesophageal guidance of lead implantation

Intervention Type 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

Lead implantation without transesophageal echocardiography (retrospective)

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

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* pre-existing RV lead
* pre-existing TR \>2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

LMU Klinikum

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Braun, MD

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Braun, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

LMU Klinikum

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

LMU Klinikum

Munich, Bavaria, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Gmeiner J, Sadoni S, Orban M, Fichtner S, Estner H, Massberg S, Hagl C, Nabauer M, Hausleiter J, Braun D. Prevention of Pacemaker Lead-Induced Tricuspid Regurgitation by Transesophageal Echocardiography Guided Implantation. JACC Cardiovasc Interv. 2021 Dec 13;14(23):2636-2638. doi: 10.1016/j.jcin.2021.08.042. No abstract available.

Reference Type DERIVED
PMID: 34887055 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

101214

Identifier Type: -

Identifier Source: org_study_id