STS/ACC Transcatheter Valve Therapy Registry (TVT Registry) (TVTR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by The Society of Thoracic Surgeons
Sponsor:
Collaborator:
American College of Cardiology
Information provided by (Responsible Party):
The Society of Thoracic Surgeons
ClinicalTrials.gov Identifier:
NCT01737528
First received: November 14, 2012
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter aortic valve replacement (TAVR) 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 aortic stenosis.


Condition Intervention
Aortic Valve Stenosis
Procedure: Transcatheter Aortic Valve Replacement

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT Registry).

Resource links provided by NLM:


Further study details as provided by The Society of Thoracic Surgeons:

Primary Outcome Measures:
  • Major adverse cardiac and cerebrovascular events [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
    increase in the 30-day risk of adverse events among patients receiving TAVR


Secondary Outcome Measures:
  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Valve Academic Research Consortium (VARC) efficacy endpoint [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
    30-day endpoints including mortality, stroke, stroke or transient ischemic attack (TIA), major vascular complications, valve related dysfunction requiring re-intervention, incident renal replacement therapy, life-threatening bleeding, and high-degree aortic valve (AV) block requiring permanent pacemaker implantation


Estimated Enrollment: 15000
Study Start Date: June 2012
Estimated Study Completion Date: June 2022
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TAVR Patients
Will include all patients 18 years or over who undergo Transcatheter Aortic Valve Replacement (TAVR) for severe aortic stenosis. The sample size will include all patients entered into the Registry.
Procedure: Transcatheter Aortic Valve Replacement
Minimal invasive implantation of a biological prothesis in Aortic Position

Detailed Description:

Purpose of the Registry

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. The first of several approaches to replacing the aortic valve without open-chest surgery has now become a reality. Other valve and delivery systems are expected to be approved in the upcoming years. 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. With the introduction of the first TAVR commercial product, the targeted patient group is the "inoperable" patient who cannot receive the traditional therapy of surgical aortic valve replacement (SAVR). It is expected that TAVR will subsequently be extended to patients who have high risk with SAVR. The marked reduction of mortality by TAVR in the inoperable patients and the similar mortality of TAVR versus SAVR in the high risk patients provide patients with a new therapy with benefits but also with a different risk profile. Patients and their families will need to make informed decisions regarding the likelihood of having a mortality benefit, of improving their functional class and quality of life, of suffering a complication, and of choosing between different care options and therapeutic approaches.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Transcatheter Aortic Valve Replacement 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 accomodate 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 Appropriate volume requirements

Criteria

Inclusion criteria:

  • 18 years or older
  • Primary indication is symptomatic primary severe aortic stenosis predicted to benefit from relief of valvular stenosis
  • Aortic valve area less than 0.8 centimeters squared
  • Mean aortic valve gradient greater than or equal to 40 mmHG
  • Peak aortic jet velocity greater than or equal to 4.0 m per second
  • Valve sheath access site is femoral, axillary, transapical, transaortic, subclavian or subaxillary
  • Patient is judged by the local heart team to be inoperable for Aortic Valve Replacement due to severe chest wall deformities or radiation effects, severe peripheral or aortic vascular disease, or severe systemic disease prohibiting the safe conduct of Cardiopulmonary Bypass (CPB)

Exclusion criteria:

  • Aortic valve annulus size is less than 18 mm or greater than 25 mm
  • Active infectious endocarditis
  • Valve in prosthetic valve procedure
  • Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737528

Contacts
Contact: Kathleen Hewitt (202) 375-6336 khewitt@acc.org
Contact: Cynthia Shewan (312) 202-5812 cshewan@sts.org

Locations
United States, District of Columbia
American College of Cardiology Recruiting
Washington, District of Columbia, United States, 20037
Contact: Kathleen Hewitt    202-375-6336    khewitt@acc.org   
Sponsors and Collaborators
The Society of Thoracic Surgeons
American College of Cardiology
Investigators
Principal Investigator: John D Carroll, MD American College of Cardiology
Principal Investigator: Fred H Edwards, MD Society of Thoracic Surgeons
  More Information

Additional Information:
No publications provided by The Society of Thoracic Surgeons

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Society of Thoracic Surgeons
ClinicalTrials.gov Identifier: NCT01737528     History of Changes
Other Study ID Numbers: TVTR-2012-01
Study First Received: November 14, 2012
Last Updated: December 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Society of Thoracic Surgeons:
severe symptomatic native aortic valve stenosis
inoperable or high risk for open aortic valve replacement

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 18, 2014