## Protocol Section
### Identification Module
**NCT ID:** NCT04167579

**Acronym:** TVT

**Brief Title:** STS & ACC Foundation's Transcutaneous Valve Therapy (TVT) Registry Foundation's Transcutaneous Valve Therapy (TVT) Registry

**Official Title:** The Society of Thoracic Surgeons and American College of Cardiology Foundation's Transcutaneous Valve Therapy (TVT) Registry

#### Organization Study ID Info
**ID:** 172-19-CV
#### Organization
**Class:** OTHER
**Full Name:** Hoag Memorial Hospital Presbyterian
### Status Module
#### Completion Date
**Date:** 2025-05-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-02-28

**Type:** ACTUAL

**Last Update Submit Date:** 2023-02-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-05-20

**Type:** ACTUAL

**Status Verified Date:** 2023-02

#### Study First Post Date
**Date:** 2019-11-19
**Type:** ACTUAL
**Study First Submit Date:** 2019-08-08
**Study First Submit QC Date:** 2019-11-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hoag Memorial Hospital Presbyterian

#### Responsible Party

**Investigator Affiliation:** Hoag Memorial Hospital Presbyterian

**Investigator Full Name:** Colleen Balius

**Investigator Title:** CLINICAL DATA COORDINATOR (RN)

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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:** 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 Module

**Conditions:**

- Transcutaneous Valve Therapies

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 5000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Year

### Arms Interventions Module

### Interventions

#### Intervention 1

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

**Name:** Transcutaneous Valve Therapy

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** increase in the 30-day risk of adverse events among patients receiving TAVR

**Measure:** Major adverse cardiac and cerebrovascular events

**Time Frame:** 30 days from procedure

#### Secondary Outcomes

**Description:** Proportion of patients who are alive with at least moderate functional improvement (defined as at least 10 point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline) at 1 year after receiving TAVR

**Measure:** Mortality

**Time Frame:** 1 year

**Description:** increase in the 1 year risk of adverse events among patients receiving TAVR

**Measure:** Major adverse cardiac and cerebrovascular events

**Time Frame:** 1 year from procedure

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** colleen.balius@hoag.org

**Name:** Colleen Balius

**Phone:** 9497641497

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Newport Beach

**Contacts:**

***Contact 1:***

- **Email:** colleen.balius@hoag.org

- **Name:** Colleen Balius, BSN, RN

- **Phone:** 949-764-1497

- **Role:** CONTACT

***Contact 2:***

- **Name:** Colleen Balius, BSN, RN

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Hoah Memorial Hospital Presbyterian

**State:** California

**Status:** RECRUITING

**Zip:** 92663

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M18592

- Name: Ichthyosis, X-Linked

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
