Clinical trial NCT01737528: STS/ACC Transcatheter Valve Therapy Registry (TVT Registry)
Official title: Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT Registry).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Keywords: severe symptomatic native aortic valve stenosis
inoperable or high risk for open aortic valve replacement
Lead sponsor: The Society of Thoracic Surgeons
Sponsor class: OTHER
Collaborators: name: American College of Cardiology
First posted: 2012-11-29
Enrollment: 16000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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 criteria: Inclusion criteria:

* 18 years or older

Primary outcomes:
measure: Major adverse cardiac and cerebrovascular events
timeFrame: 30 day
Secondary outcomes:
measure: Mortality
timeFrame: 1 year
Other outcomes:
measure: Valve Academic Research Consortium (VARC) efficacy endpoint
timeFrame: 30 day
Locations:
city: Washington
country: United States
facility: American College of Cardiology
state: District of Columbia
Study officials:
affiliation: American College of Cardiology
name: John D Carroll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Society of Thoracic Surgeons
name: Fred H Edwards, MD
role: PRINCIPAL_INVESTIGATOR
References:
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