Severe Symptomatic Aortic StenosisInop AANCT01787084
Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis
An observational study of Severe Symptomatic Aortic Stenosis, run by The Society of Thoracic Surgeons.
Trial summary
Investigational study of Edwards Lifesciences, LLC's "Edwards SAPIEN Transcatheter Heart Valve" for non-femoral delivery, (or alternative access deliver) in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Symptomatic Aortic Stenosis
- What is being tested?
- Edwards SAPIEN Transcatheter Heart Valve
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study cohort will include all TVT Registry data obtained for inoperable patients age 18 years or older who undergo TAVR for severe aortic stenosis using any non-femoral access approach with an Edwards SAPIEN device between the start date and December 31, 2018
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: Transcatheter Valve Therapy (TVT) Registry Assessment of Alternative Access Approaches for Transcatheter Aortic Valve Replacement (TAVR) in Inoperable Patients With Severe Aortic Stenosis
Investigational study of Edwards Lifesciences, LLC's "Edwards SAPIEN Transcatheter Heart Valve" for non-femoral delivery, (or alternative access deliver) in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis. Will outcomes observed in a high-risk operable transapical native valve TAVR cohort receiving an Edwards SAPIEN device compare to inoperable patients undergoing alternative access TAVR with the Edwards SAPIEN device experience a reasonably similar incidence of 30 day adverse events?
Read the detailed description
Transcatheter aortic valve replacement (TAVR) using the Edwards SAPIEN valve and Retroflex 3 delivery system provides both a mortality and quality of life benefit for inoperable patients. Only the transfemoral (TF) access has been approved in the US. A substantial number of patients cannot have a TF approach due to inadequate vessel size, vessel disease, or other anatomical considerations. The pivotal study did not include an assessment of safety and effectiveness of alternative access approaches in this inoperable patient group.
Early approaches to TAVR included a femoral transvenous approach with transseptal access to the left side for delivery of the valve. This approach avoided large bore arterial catheterization, but it had unacceptable rates of complications and lacked reproducibility. Alternative access approaches have been developed because of the risks associated with inserting large caliber catheters into small, diseased femoral arteries often associated with diffuse vasculopathy. To avoid the vascular complications from femoral access, other transcatheter approaches have been developed to include open surgical access to the left ventricular apex (TA), ascending aorta, (TAO), subclavian and axillary arteries (TS), and retroperitoneal access to the iliac artery (TI) as well as distal aorta. In addition to providing TAVR to patients who cannot have TF access, additional advantages include better catheter control and safer closure of the access site. Commonly cited disadvantages include the need for surgical expertise and additional equipment, along with the potential for longer recovery, more incisional pain, greater radiation exposure for operators, unsuitable delivery catheters for alternative access sites, and a host of unique alternative access site complications.
We propose to collectively analyze 30-day safety endpoints as a lumped data group for these alternative access approaches. These data are gathered from clinical practice in real-world settings and submitted to the TVT Registry. It is expected that centers will choose among the various choices for alternative access based the causative factors underlying the need for alternative access, as well as local skill sets and experience. For this lumped data group of alternative access approaches we will compare 30-day safety results to the TA outcomes reported from Cohort A of the PARTNERS 1 trial. We recognize that these TA patients were high risk operable patients rather than inoperable patients, but no other direct comparator group is available. We reason that the TA data from this published clinical trial are high quality, represent an alternative access approach rather than TF, and will provide a frequency of safety endpoints that have been found to be acceptable both clinically and from a regulatory perspective.
- Conditions
- Severe Symptomatic Aortic Stenosis
- Being tested
- Edwards SAPIEN Transcatheter Heart Valve
- Keywords
- Aortic Stenosis, TAVR
- 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.
Edwards SAPIEN Transcatheter Heart ValveDevice
Non-femoral transcatheter delivery of heart valve
| Study group | Role | What they receive |
|---|---|---|
| Inoperable Patients Alternative Access | Non-femoral delivery (or alternative access) in patients iwht severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis Receives: Device: Edwards SAPIEN Transcatheter Heart Valve |
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; Modified 30 day Valve Academic Research Consortium (VARC) Composite Early Safety Endpoint
Measured: 30 day
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 TAVR
Measured: 1 year
Secondary outcomes (1)
30-day endpoints for major morbidity
Endpoints include: 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
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startApr 2016
- Primary completionMar 2025
- Study completionMar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Symptomatic Aortic 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
- 8 participants (actual)
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
- NCT01787084
- Sponsor's protocol ID
- TVTR-2012-02
- Acronym
- Inop AA
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2013
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Valve Therapy (TVT) Registry Assessment of Alternative Access Approaches for Transcatheter Aortic Valve Replacement (TAVR) in Inoperable Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT01787084
- Acronym / sponsor ID
- Inop AA / TVTR-2012-02
- Conditions
- Severe Symptomatic Aortic Stenosis
- Keywords
- Aortic Stenosis, TAVR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The Society of Thoracic SurgeonsUniversity, hospital or other
- Collaborators
- American College of Cardiology
- Study start
- Apr 2016
- Primary completion
- Mar 2025 (actual)
- Study completion
- Mar 2025 (actual)
- First posted
- 8 Feb 2013 (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.
Investigational study of Edwards Lifesciences, LLC's "Edwards SAPIEN Transcatheter Heart Valve" for non-femoral delivery, (or alternative access deliver) in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis. Will outcomes observed in a high-risk operable transapical native valve TAVR cohort receiving an Edwards SAPIEN device compare to inoperable patients undergoing alternative access TAVR with the Edwards SAPIEN device experience a reasonably similar incidence of 30 day adverse events?
Detailed description
Transcatheter aortic valve replacement (TAVR) using the Edwards SAPIEN valve and Retroflex 3 delivery system provides both a mortality and quality of life benefit for inoperable patients. Only the transfemoral (TF) access has been approved in the US. A substantial number of patients cannot have a TF approach due to inadequate vessel size, vessel disease, or other anatomical considerations. The pivotal study did not include an assessment of safety and effectiveness of alternative access approaches in this inoperable patient group.
Early approaches to TAVR included a femoral transvenous approach with transseptal access to the left side for delivery of the valve. This approach avoided large bore arterial catheterization, but it had unacceptable rates of complications and lacked reproducibility. Alternative access approaches have been developed because of the risks associated with inserting large caliber catheters into small, diseased femoral arteries often associated with diffuse vasculopathy. To avoid the vascular complications from femoral access, other transcatheter approaches have been developed to include open surgical access to the left ventricular apex (TA), ascending aorta, (TAO), subclavian and axillary arteries (TS), and retroperitoneal access to the iliac artery (TI) as well as distal aorta. In addition to providing TAVR to patients who cannot have TF access, additional advantages include better catheter control and safer closure of the access site. Commonly cited disadvantages include the need for surgical expertise and additional equipment, along with the potential for longer recovery, more incisional pain, greater radiation exposure for operators, unsuitable delivery catheters for alternative access sites, and a host of unique alternative access site complications.
We propose to collectively analyze 30-day safety endpoints as a lumped data group for these alternative access approaches. These data are gathered from clinical practice in real-world settings and submitted to the TVT Registry. It is expected that centers will choose among the various choices for alternative access based the causative factors underlying the need for alternative access, as well as local skill sets and experience. For this lumped data group of alternative access approaches we will compare 30-day safety results to the TA outcomes reported from Cohort A of the PARTNERS 1 trial. We recognize that these TA patients were high risk operable patients rather than inoperable patients, but no other direct comparator group is available. We reason that the TA data from this published clinical trial are high quality, represent an alternative access approach rather than TF, and will provide a frequency of safety endpoints that have been found to be acceptable both clinically and from a regulatory perspective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inoperable Patients Alternative Access | – | Device: Edwards SAPIEN Transcatheter Heart ValveNon-femoral delivery (or alternative access) in patients iwht severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort will include all TVT Registry data obtained for inoperable patients age 18 years or older who undergo TAVR for severe aortic stenosis using any non-femoral access approach with an Edwards SAPIEN device between the start date and December 31, 2018
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Edwards SAPIEN Transcatheter Heart ValveNon-femoral transcatheter delivery of heart valve | Device | Inoperable Patients Alternative Access |
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; Modified 30 day Valve Academic Research Consortium (VARC) Composite Early Safety Endpoint
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 TAVR
1 secondary outcome
30-day endpoints for major morbidity
Time frame: 30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
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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. This study is not recruiting at the moment.
John D Carroll, MD principal investigator
American College of Cardiology
Fred H Edwards, MD principal investigator
Society of Thoracic Surgeons
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Symptomatic Aortic Stenosis, run by The Society of Thoracic Surgeons.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac and cerebrovascular events (time frame: 30 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2025.