Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-13 @ 5:54 PM
Study NCT ID:
NCT04945005
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry
Sponsor:
LMU Klinikum
Organization:
Study Overview
Official Title:
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLACE
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: