Clinical trial NCT04945005: Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry
Official title: Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Valve Insufficiency
Pacemaker Complication
Echocardiography, Transesophageal
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients undergoing pacemaker/ICD implantation including a transtricuspid lead were included in this registry.

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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* pre-existing RV lead
* pre-existing TR \>2

Primary outcomes:
measure: Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)
timeFrame: 2 - 7 days post-implant (at hospital discharge)
Secondary outcomes:
measure: Dose-are product
timeFrame: Intraprocedural
measure: Lead revisions
timeFrame: 30 days
measure: Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)
timeFrame: 3 months
measure: Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)
timeFrame: 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: LMU Klinikum
state: Bavaria
Study officials:
affiliation: LMU Klinikum
name: Daniel Braun, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.