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STS/ACC TVT Registry Mitral Module (TMVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02245763
Recruitment Status : Recruiting
First Posted : September 22, 2014
Last Update Posted : July 19, 2019
The Society of Thoracic Surgeons
Information provided by (Responsible Party):
American College of Cardiology

Brief 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.

Condition or disease Intervention/treatment
Mitral Valve Regurgitation Device: Leaflet Clip

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 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.

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Society of Thoracic Surgeons/ American College of Cardiology Transcatheter Valve Therapies Registry Mitral Module
Study Start Date : November 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 31, 2019

Primary Outcome Measures :
  1. Number of Patients with Adverse Events [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Transcatheter Mitral Valve Repair must be furnished in a hospital with the appropriate infrastructre that includes, but is not limited to on site heart valve surgery program cardiac catheterization lab or hybrid operating room with a fixed radiographic imaging system with flat panel fluoroscopy, offering quality imaging non-invasive imaging such as echocardiography, vascular ultrasound, computed tomography and magnetic resonance. Sufficient space, in a sterile environment, to accommodate necessary equipment for cases with and without complications. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02245763

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Contact: Joan K Michaels, RN 202-375-6309

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United States, District of Columbia
American College of Cardiology Recruiting
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
American College of Cardiology
The Society of Thoracic Surgeons

Additional Information:
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Responsible Party: American College of Cardiology Identifier: NCT02245763    
Other Study ID Numbers: 3000-2
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases