STS/ACC TVT Registry Mitral Module

Mitral Valve Regurgitation Clinical Trial

— TMVR  

Official title:

The Society of Thoracic Surgeons/ American College of Cardiology Transcatheter Valve Therapies Registry Mitral Module

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02245763
• Other study ID #: 3000-2
• Status: Recruiting
• Start date: November 2013
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: American College of Cardiology
• Contact: Joan K Michaels, RN
• Phone: 202-375-6309
• Email: jmichael[@]acc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter mitral valve repair (TMVR) procedure. Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT Registry is designed to monitor the safety and efficacy of this new procedure for the treatment of mitral valve disease.

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 for post market studies.

Background and Significance

Transcatheter valve therapies are now emerging into clinical practice from the research phase in the United States. An Expert Consensus Document on Transcatheter Valve Therapy has outlined the initial technology, targeted patient population, and the multidisciplinary heart team and specialized facilities needed. The document also proposes the establishment of a national registry of patients with valvular heart disease that can collect and analyze data as these new valve treatment options become available. Surveillance of device performance, monitoring of long-term outcomes, and performance of comparative effectiveness research are some of the proposed uses of the registry.

Transcatheter valve therapies have emerged because of unmet patient needs. Furthermore, TVT has developed at a time when degenerative heart valve diseases of both the mitral and aortic valves are increasing in frequency as the population ages.

For these patients there are unique issues such as the prioritization of the health related quality of life versus the quantity of life, the desire to preserve independence and avoid becoming a burden to families, and the need to clearly understand what about their current condition is reversible versus irreversible and linked to other conditions and aging. These issues become further highlighted when considering the considerable costs and other treatment burdens of the TVT technologies versus the disabling symptoms and recurrent hospitalizations caused by untreated severe valvular heart disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• All patients

Exclusion Criteria:

• Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen

• Active endocarditis of the mitral valve

• Rheumatic mitral valve disease

• Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• Leaflet Clip

Locations

Country	Name	City	State
United States	American College of Cardiology	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
American College of Cardiology	The Society of Thoracic Surgeons

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with Adverse Events		30 days

External Links

•   Related Info