Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04570163
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2020-09-20
Brief Title:
Berlin Registry of Right Heart Interventions
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Berlin Registry of Right Heart Interventions
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The present study evaluates patients after interventional therapy of valvular diseases of the right heart Follow-up examinations include medical history taking laboratory measurements and an echo The aim is to assess the different interventional therapies and their impact on patients outcome
Detailed Description:
The subject of the study is to register interventional therapies of right heart diseases such as cardioband and edge-to-edge techniques of the tricuspid valve performed in Berlin Brandenburg primarily at the Charité Universitätsmedizin Berlin Based on the development and the increasing use of interventional therapies in tricuspid and pulmonary valve diseases the impact on the patients symptoms and life expectancy after interventions will be investigated The aim is to identify patient subgroups that benefit the most
Primary endpoints Total mortality cardiovascular mortality heart failure hospitalization
Secondary endpoints NYHA class NTproBNP liver and kidney function laboratory measurements valve function cardiac function and cardiac morphology
Primary endpoints Total mortality cardiovascular mortality heart failure hospitalization
Secondary endpoints NYHA class NTproBNP liver and kidney function laboratory measurements valve function cardiac function and cardiac morphology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None