STS & ACC Foundation's Transcutaneous Valve Therapy (TVT) Registry Foundation's Transcutaneous Valve Therapy (TVT) Registry

NCT ID: NCT04167579

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-20

Study Completion Date

2025-05-20

Brief Summary

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The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies.

Detailed Description

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The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies. Patient-level data are submitted by participating hospitals to The Society of Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT Registry. The purposes of the TVT Registry include: (i) collecting pertinent and standardized data elements from participating hospitals, health care providers and others that measure and assess the quality of care for patients receiving TVT; (ii) providing confidential periodic reports to participating hospitals, health care providers and others, to evaluate and improve the quality of care in these areas; and (iii) permitting and fostering appropriate research based upon the data collected by means of the TVT Registry.

The secondary aim of the TVT Registry is to serve as a scalable data infrastructure forpost market studies.

Conditions

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Transcutaneous Valve Therapies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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Transcutaneous Valve Therapy

Any patient who undergoes an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients (age 18 and older) who undergo an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoag Memorial Hospital Presbyterian

OTHER

Sponsor Role lead

Responsible Party

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Colleen Balius

CLINICAL DATA COORDINATOR (RN)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hoah Memorial Hospital Presbyterian

Newport Beach, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Colleen Balius

Role: CONTACT

9497641497

Facility Contacts

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Colleen Balius, BSN, RN

Role: primary

949-764-1497

Other Identifiers

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172-19-CV

Identifier Type: -

Identifier Source: org_study_id

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