Aortic Valve StenosisTVTRNCT01737528
STS/ACC Transcatheter Valve Therapy Registry (TVT Registry)
An observational study of Aortic Valve Stenosis, run by The Society of Thoracic Surgeons at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Transcatheter Aortic Valve Replacement
- Type of treatment
- Surgery or procedure
- How many people
- 16,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2035
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 18 years or older
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
American College of Cardiology
Washington D.C., District of Columbia, 20037
Joan Michaels, 202-375-6309, jmichael@acc.org
About this study
Official title: Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT Registry).
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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Transcatheter Aortic Valve Replacement
- Keywords
- severe symptomatic native aortic valve stenosis, inoperable or high risk for open aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ReplacementProcedure or surgery
Minimal invasive implantation of a biological prothesis in Aortic Position
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Transcatheter Aortic Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebrovascular events
increase in the 30-day risk of adverse events among patients receiving TAVR
Measured: 30 day
Secondary outcomes (1)
Mortality
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2035 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- The Society of Thoracic Surgeons
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Cardiology
- Responsible party
- Sponsor
- Investigators
- John D Carroll, MD, Principal investigator, American College of CardiologyFred H Edwards, MD, Principal investigator, Society of Thoracic Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737528
- Sponsor's protocol ID
- TVTR-2012-01
- Acronym
- TVTR
- Status last verified
- Nov 2021
- First submitted
- 14 Nov 2012
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang GHL, Sengupta A, Alexis SL, Bapat VN, Adams DH, Sharma SK, Kini AS, Kodali SK, Ramlawi B, Gada H, Vora AN, Forrest JK, Kaple RK, Liu F, Reardon MJ. Outcomes of Prosthesis-Patient Mismatch Following Supra-Annular Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry. JACC Cardiovasc Interv. 2021 May 10;14(9):964-976. doi: 10.1016/j.jcin.2021.03.040.
PubMed 33958170Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, Kirtane AJ, Fitzgerald S, Michaels J, Krohn C, Masoudi FA, Brindis RG, Bavaria JE. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. Ann Thorac Surg. 2021 Feb;111(2):701-722. doi: 10.1016/j.athoracsur.2020.09.002. Epub 2020 Nov 16.
PubMed 33213826Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, Kirtane AJ, Fitzgerald S, Michaels J, Krohn C, Masoudi FA, Brindis RG, Bavaria JE. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020 Nov 24;76(21):2492-2516. doi: 10.1016/j.jacc.2020.09.595.
PubMed 33213729Attizzani GF, Patel SM, Dangas GD, Szeto WY, Sorajja P, Reardon MJ, Popma JJ, Kodali S, Chenoweth S, Costa MA. Comparison of Local Versus General Anesthesia Following Transfemoral Transcatheter Self-Expanding Aortic Valve Implantation (from the Transcatheter Valve Therapeutics Registry). Am J Cardiol. 2019 Feb 1;123(3):419-425. doi: 10.1016/j.amjcard.2018.10.041. Epub 2018 Nov 6.
PubMed 30527797Abramowitz Y, Vemulapalli S, Chakravarty T, Li Z, Kapadia S, Holmes D, Matsouaka RA, Wang A, Cheng W, Forrester JS, Smalling R, Thourani V, Mack M, Leon M, Makkar RR. Clinical Impact of Diabetes Mellitus on Outcomes After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Circ Cardiovasc Interv. 2017 Nov;10(11):e005417. doi: 10.1161/CIRCINTERVENTIONS.117.005417.
PubMed 29138245Fanaroff AC, Manandhar P, Holmes DR, Cohen DJ, Harrison JK, Hughes GC, Thourani VH, Mack MJ, Sherwood MW, Jones WS, Vemulapalli S. Peripheral Artery Disease and Transcatheter Aortic Valve Replacement Outcomes: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Therapy Registry. Circ Cardiovasc Interv. 2017 Oct;10(10):e005456. doi: 10.1161/CIRCINTERVENTIONS.117.005456.
PubMed 29042398Carroll JD, Vemulapalli S, Dai D, Matsouaka R, Blackstone E, Edwards F, Masoudi FA, Mack M, Peterson ED, Holmes D, Rumsfeld JS, Tuzcu EM, Grover F. Procedural Experience for Transcatheter Aortic Valve Replacement and Relation to Outcomes: The STS/ACC TVT Registry. J Am Coll Cardiol. 2017 Jul 4;70(1):29-41. doi: 10.1016/j.jacc.2017.04.056.
PubMed 28662805Alfredsson J, Stebbins A, Brennan JM, Matsouaka R, Afilalo J, Peterson ED, Vemulapalli S, Rumsfeld JS, Shahian D, Mack MJ, Alexander KP. Gait Speed Predicts 30-Day Mortality After Transcatheter Aortic Valve Replacement: Results From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Circulation. 2016 Apr 5;133(14):1351-9. doi: 10.1161/CIRCULATIONAHA.115.020279. Epub 2016 Feb 26.
PubMed 26920495Mack MJ, Brennan JM, Brindis R, Carroll J, Edwards F, Grover F, Shahian D, Tuzcu EM, Peterson ED, Rumsfeld JS, Hewitt K, Shewan C, Michaels J, Christensen B, Christian A, O'Brien S, Holmes D; STS/ACC TVT Registry. Outcomes following transcatheter aortic valve replacement in the United States. JAMA. 2013 Nov 20;310(19):2069-77. doi: 10.1001/jama.2013.282043.
PubMed 24240934Carroll JD, Edwards FH, Marinac-Dabic D, Brindis RG, Grover FL, Peterson ED, Tuzcu EM, Shahian DM, Rumsfeld JS, Shewan CM, Hewitt K, Holmes DR Jr, Mack MJ. The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies. J Am Coll Cardiol. 2013 Sep 10;62(11):1026-34. doi: 10.1016/j.jacc.2013.03.060. Epub 2013 May 1.
PubMed 23644082
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT Registry).
- ClinicalTrials.gov ID
- NCT01737528
- Acronym / sponsor ID
- TVTR / TVTR-2012-01
- Conditions
- Aortic Valve Stenosis
- Keywords
- severe symptomatic native aortic valve stenosis, inoperable or high risk for open aortic valve replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- The Society of Thoracic SurgeonsUniversity, hospital or other
- Collaborators
- American College of Cardiology
- Study start
- Jun 2012 (actual)
- Primary completion
- Jun 2035 (estimated)
- Study completion
- Jun 2035 (estimated)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVR Patients | – | Procedure: Transcatheter Aortic Valve ReplacementWill 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 18 years or older
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve ReplacementMinimal invasive implantation of a biological prothesis in Aortic Position | Procedure or surgery | TAVR Patients |
Primary outcome
Major adverse cardiac and cerebrovascular events
Time frame: 30 day
increase in the 30-day risk of adverse events among patients receiving TAVR
1 secondary outcome
Mortality
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Derived from this study: PubMed 33958170Tang GHL, Sengupta A, Alexis SL, Bapat VN, Adams DH, Sharma SK, Kini AS, Kodali SK, Ramlawi B, Gada H, Vora AN, Forrest JK, Kaple RK, Liu F, Reardon MJ. Outcomes of Prosthesis-Patient Mismatch Following Supra-Annular Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry. JACC Cardiovasc Interv. 2021 May 10;14(9):964-976. doi: 10.1016/j.jcin.2021.03.040.
- Derived from this study: PubMed 33213826Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, Kirtane AJ, Fitzgerald S, Michaels J, Krohn C, Masoudi FA, Brindis RG, Bavaria JE. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. Ann Thorac Surg. 2021 Feb;111(2):701-722. doi: 10.1016/j.athoracsur.2020.09.002. Epub 2020 Nov 16.
- Derived from this study: PubMed 33213729Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, Kirtane AJ, Fitzgerald S, Michaels J, Krohn C, Masoudi FA, Brindis RG, Bavaria JE. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020 Nov 24;76(21):2492-2516. doi: 10.1016/j.jacc.2020.09.595.
- Derived from this study: PubMed 30527797Attizzani GF, Patel SM, Dangas GD, Szeto WY, Sorajja P, Reardon MJ, Popma JJ, Kodali S, Chenoweth S, Costa MA. Comparison of Local Versus General Anesthesia Following Transfemoral Transcatheter Self-Expanding Aortic Valve Implantation (from the Transcatheter Valve Therapeutics Registry). Am J Cardiol. 2019 Feb 1;123(3):419-425. doi: 10.1016/j.amjcard.2018.10.041. Epub 2018 Nov 6.
- Derived from this study: PubMed 29138245Abramowitz Y, Vemulapalli S, Chakravarty T, Li Z, Kapadia S, Holmes D, Matsouaka RA, Wang A, Cheng W, Forrester JS, Smalling R, Thourani V, Mack M, Leon M, Makkar RR. Clinical Impact of Diabetes Mellitus on Outcomes After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Circ Cardiovasc Interv. 2017 Nov;10(11):e005417. doi: 10.1161/CIRCINTERVENTIONS.117.005417.
- Derived from this study: PubMed 29042398Fanaroff AC, Manandhar P, Holmes DR, Cohen DJ, Harrison JK, Hughes GC, Thourani VH, Mack MJ, Sherwood MW, Jones WS, Vemulapalli S. Peripheral Artery Disease and Transcatheter Aortic Valve Replacement Outcomes: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Therapy Registry. Circ Cardiovasc Interv. 2017 Oct;10(10):e005456. doi: 10.1161/CIRCINTERVENTIONS.117.005456.
- Derived from this study: PubMed 28662805Carroll JD, Vemulapalli S, Dai D, Matsouaka R, Blackstone E, Edwards F, Masoudi FA, Mack M, Peterson ED, Holmes D, Rumsfeld JS, Tuzcu EM, Grover F. Procedural Experience for Transcatheter Aortic Valve Replacement and Relation to Outcomes: The STS/ACC TVT Registry. J Am Coll Cardiol. 2017 Jul 4;70(1):29-41. doi: 10.1016/j.jacc.2017.04.056.
- Derived from this study: PubMed 26920495Alfredsson J, Stebbins A, Brennan JM, Matsouaka R, Afilalo J, Peterson ED, Vemulapalli S, Rumsfeld JS, Shahian D, Mack MJ, Alexander KP. Gait Speed Predicts 30-Day Mortality After Transcatheter Aortic Valve Replacement: Results From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Circulation. 2016 Apr 5;133(14):1351-9. doi: 10.1161/CIRCULATIONAHA.115.020279. Epub 2016 Feb 26.
- Derived from this study: PubMed 24240934Mack MJ, Brennan JM, Brindis R, Carroll J, Edwards F, Grover F, Shahian D, Tuzcu EM, Peterson ED, Rumsfeld JS, Hewitt K, Shewan C, Michaels J, Christensen B, Christian A, O'Brien S, Holmes D; STS/ACC TVT Registry. Outcomes following transcatheter aortic valve replacement in the United States. JAMA. 2013 Nov 20;310(19):2069-77. doi: 10.1001/jama.2013.282043.
- Derived from this study: PubMed 23644082Carroll JD, Edwards FH, Marinac-Dabic D, Brindis RG, Grover FL, Peterson ED, Tuzcu EM, Shahian DM, Rumsfeld JS, Shewan CM, Hewitt K, Holmes DR Jr, Mack MJ. The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies. J Am Coll Cardiol. 2013 Sep 10;62(11):1026-34. doi: 10.1016/j.jacc.2013.03.060. Epub 2013 May 1.
- Link to homepage for STS/ACC TVT RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John D Carroll, MD principal investigator
American College of Cardiology
Fred H Edwards, MD principal investigator
Society of Thoracic Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by The Society of Thoracic Surgeons at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joan Michaels ((202) 375 6309, jmichael@acc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac and cerebrovascular events (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01737528, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.