Heart Transplant Registry of Városmajor | NCT02347371

Studies
Heart Transplant Registry of Városmajor

NCT02347371

Sponsor

Semmelweis University Heart and Vascular Center

Status

Completed

Last Update Posted

Apr 23, 2021Actual

Enrollment

11Actual

Phase

Not provided

Conditions

Disorder Related to Cardiac Transplantation

Interventions

Not provided

Countries

Hungary

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

May 2020Actual

Completion Date

May 2020Actual

First Submitted Date

Jan 15, 2015

First Submission Date that Met QC Criteria

Jan 21, 2015

First Posted Date

Jan 27, 2015Estimated

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

Apr 22, 2021

Last Update Posted Date

Apr 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this registry is to determine the long term outcomes of heart transplantations performed at the Semmelweis University Heart and Vascular Center. All eventual interventional and non-interventional procedures will be accounted for and summarized.

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

Retention

Enrollment

11Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Outcome of heart transplantation as measured by all-cause mortality	All-cause mortality will be assessed after transplantation in all participating subjects.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Morbidity after heart transplantation	All invasive procedures that are required after initial surgery will be tracked and accounted for.	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Heart transplant recipient
>18 years old
Signed informed consent
Cared for at the Semmelweis University Heart and Vascular Center

Exclusion Criteria:

Denies consent to registry

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Heart transplant recipient, cared for by the Semmelweis University Heart and Vascular Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Béla Merkely, MD PhD DSc	Semmelweis University Heart and Vascular Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Semmelweis University Heart and Vascular Center		Budapest		1122	Hungary