STS/ACC Transcatheter Valve Therapy Registry (TVT Registry) (TVTR)
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| ClinicalTrials.gov Identifier: NCT01737528 |
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Recruitment Status :
Recruiting
First Posted : November 29, 2012
Last Update Posted : August 25, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Aortic Valve Stenosis | Procedure: Transcatheter Aortic Valve Replacement |
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.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 16000 participants |
| 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). |
| Actual Study Start Date : | June 2012 |
| Estimated Primary Completion Date : | June 2035 |
| Estimated Study Completion Date : | June 2035 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Procedure: Transcatheter Aortic Valve Replacement
Minimal invasive implantation of a biological prothesis in Aortic Position |
- Major adverse cardiac and cerebrovascular events [ Time Frame: 30 day ]increase in the 30-day risk of adverse events among patients receiving TAVR
- Mortality [ Time Frame: 1 year ]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
- Valve Academic Research Consortium (VARC) efficacy endpoint [ Time Frame: 30 day ]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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion criteria:
- 18 years or older
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 ClinicalTrials.gov identifier (NCT number): NCT01737528
| Contact: Joan Michaels | (202) 375 6309 | jmichael@acc.org |
| United States, District of Columbia | |
| American College of Cardiology | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Contact: Joan Michaels 202-375-6309 jmichael@acc.org | |
| Principal Investigator: | John D Carroll, MD | American College of Cardiology | |
| Principal Investigator: | Fred H Edwards, MD | Society of Thoracic Surgeons |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | The Society of Thoracic Surgeons |
| ClinicalTrials.gov Identifier: | NCT01737528 |
| Other Study ID Numbers: |
TVTR-2012-01 |
| First Posted: | November 29, 2012 Key Record Dates |
| Last Update Posted: | August 25, 2022 |
| Last Verified: | November 2021 |
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severe symptomatic native aortic valve stenosis inoperable or high risk for open aortic valve replacement |
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Aortic Valve Stenosis Aortic Valve Disease Heart Valve Diseases |
Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |