Transcatheter Interventions for Tricuspid Insufficiency i... | NCT04735003

Studies
Transcatheter Interventions for Tricuspid Insufficiency in Italy

NCT04735003

Sponsor

Marianna Adamo

Status

Recruiting

Last Update Posted

Feb 2, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Tricuspid Valve Insufficiency

Interventions

Transcatheter tricuspid valve interventions

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2021Estimated

Primary Completion Date

Jan 30, 2026Estimated

Completion Date

Jan 30, 2027Estimated

First Submitted Date

Jan 16, 2021

First Submission Date that Met QC Criteria

Jan 30, 2021

First Posted Date

Feb 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2021

Last Update Posted Date

Feb 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marianna Adamo, Principal investigator, Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaSponsor-Investigator

Lead Sponsor

Marianna AdamoOTHER

Collaborators

Name	Class
San Raffaele University Hospital, Italy	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. The aim is to report clinical characteristics, procedural results and short- and long-term outcomes of patients undergoing transcatheter tricuspid valve interventions in Italian centres.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcatheter tricuspid valve interventions	Device	Transcatheter repair or replacement to treat tricuspid regurgitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause death		1-year
Cardiovascular death or heart failure hospitalization		1-year

Secondary Outcomes

Measure	Description	Time Frame
Changes in tricuspid regurgitation degree		30-day, 1-year and 5-year
Changes in NYHA class		30-day, 1-year and 5-year
Changes in right ventricular dimensions and function

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing transcatheter treatment of tricuspid regurgitation (native valve -with or without previous surgical valve repair - or degenerated bioprosthesis)
Patients who are willing and capable of providing informed consent, and participating in all follow-ups associated with this clinical investigation.

Exclusion Criteria:

Valve anatomy unsuitable for transcatheter tricuspid valve interventions.
Subjects who are unable or not willing to complete follow-up visits and examination for the duration of the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with significant tricuspid regurgitation who need transcatheter tricuspid valve intervention.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marianna Adamo	Contact	+390303995564		mariannaadamo@hotmail.com
Paolo Denti	Contact			paolodenti@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marianna Adamo	Recruiting	Brescia	Lombardy	25123	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided