Aortic Valve StenosisPhase 1NCT02280824
Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access
A Phase 1 study testing CA-TAVR and Amplatzer Duct Occluder in people with Aortic Valve Stenosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 15 sites in United States.
Trial summary
Background: Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that are too small and are too sick for standard techniques. But they may benefit from a new technique called transcaval TAVR. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- CA-TAVR and Amplatzer Duct Occluder
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 15 sitesUnited States
- Study dates
- 30 Oct 2014to 28 Dec 2018
- Phase
- Phase 1
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age greater than or equal to 21 years
- Severe symptomatic de novo aortic valve stenosis or bioprosthetic aortic valve failure for which transcatheter aortic valve replacement (TAVR) is felt beneficial according to the consensus of the institutional multidisciplinary heart team
- Extreme risk or inoperability for TAVR via conventional femoral artery, trans-apical, or trans-aortic access in the determination of the multidisciplinary heart team. This determination includes an in-person consultation by at least one cardiac surgeon member of the heart team.
- Anatomic eligibility for caval-aortic TAVR, graded as favorable or feasible based on NHLBI core lab assessment of the baseline CT examination.
Who cannot join
- Unable or unwilling to consent to participate
- Anatomic eligibility for caval-aortic TAVR graded as unfavorable based on NHLBI core lab assessment of the baseline CT examination
- Unlikely to benefit from caval-aortic TAVR
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Emory University
Atlanta, Georgia, 30322-1102
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Henry Ford Hospital
Detroit, Michigan, 48202
NorthShore University HealthSystem, Evanston Hospital
Evanston, Illinois, 60201
INOVA Fairfax Hospital
Falls Church, Virginia, 22042
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, 37232
Ochsner Health System
New Orleans, Louisiana, 70121
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Advocate Heart Institute
Oakbrook Terrace, Illinois, 60181
Carilion Medical Center
Roanoke, Virginia, 24014
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest University
Winston-Salem, North Carolina, 27103
York Hospital
York, Pennsylvania, 17403
About this study
Official title: Transcaval Access for Transcatheter Aortic Valve Replacement in Patients With No Good Options for Aortic Access
Background:
- Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that are too small and are too sick for standard techniques. But they may benefit from a new technique called transcaval TAVR. For this technique, doctors make a hole between the largest vein (vena cava) and largest artery (aorta) in the body, inside the abdomen. Then they replace the valve through a tube they put in the groin vein. Then they close the hole between the vein and the artery using a device designed to close holes in the heart. This study tests the device for this new, off-label use.
Read more
Objective:
- To further study the safety and effectiveness of transcaval TAVR.
Eligibility:
- Adults age 21 and older who would benefit from TAVR but for whom standard techniques are not suitable.
Design:
- Participants will be selected by a team of heart specialists and others.
- Participants will have a computed tomography (CT) scan with or without contrast dye.
- Participants will have blood tests.
- Participants will have transcaval TAVR.
- Participants will receive the same standard care as for all patients with TAVR.
- Participants will also have another CT scan, or an MRI or ultrasound, before they leave the hospital, and again after about 30 days and after about 12 months.
- Participants will be contacted 1 and 6 months afterwards and will have another visit 1 year later. They will have a CT, MRI, or ultrasound. They will have blood tests and a physical exam.
Read the detailed description
Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) has enabled transcatheter aortic valve replacement (TAVR) in a small number of patients who have no good options for standard percutaneous femoral access or for standard surgical access to the cardiac apex or to the ascending aorta. In this prospective registry we will collect data from multiple medical centers as they offer transcaval TAVR to patients with extreme or prohibitive risk of conventional TAVR.
- Conditions
- Aortic Valve Stenosis
- Being tested
- CA-TAVR, Amplatzer Duct Occluder
- Keywords
- Transcaval, TAVR, AMPLATZER(R) Occluder
- 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.
CA-TAVRProcedure or surgery
Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access
Amplatzer Duct OccluderDevice
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access Receives: Procedure: CA-TAVR; Device: Amplatzer Duct Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access
The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access
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 posted3 Nov 2014 (estimated)
- Study start30 Oct 2014
- Primary completion27 Jul 2017
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280824
- Sponsor's protocol ID
- 999915009
- Other IDs
- 15-H-N009
- Status last verified
- 28 Dec 2018
- First submitted
- 30 Oct 2014
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
PubMed 20961243Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
PubMed 21639811Greenbaum AB, O'Neill WW, Paone G, Guerrero ME, Wyman JF, Cooper RL, Lederman RJ. Caval-aortic access to allow transcatheter aortic valve replacement in otherwise ineligible patients: initial human experience. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2795-804. doi: 10.1016/j.jacc.2014.04.015. Epub 2014 May 7.
PubMed 24814495Halabi M, Ratnayaka K, Faranesh AZ, Chen MY, Schenke WH, Lederman RJ. Aortic access from the vena cava for large caliber transcatheter cardiovascular interventions: pre-clinical validation. J Am Coll Cardiol. 2013 Apr 23;61(16):1745-6. doi: 10.1016/j.jacc.2013.01.057. Epub 2013 Apr 2. No abstract available.
PubMed 23500317Lederman RJ, Babaliaros VC, Rogers T, Stine AM, Chen MY, Muhammad KI, Leonardi RA, Paone G, Khan JM, Leshnower BG, Thourani VH, Tian X, Greenbaum AB. The Fate of Transcaval Access Tracts: 12-Month Results of the Prospective NHLBI Transcaval Transcatheter Aortic Valve Replacement Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):448-456. doi: 10.1016/j.jcin.2018.11.035.
PubMed 30846083Greenbaum AB, Babaliaros VC, Chen MY, Stine AM, Rogers T, O'Neill WW, Paone G, Thourani VH, Muhammad KI, Leonardi RA, Ramee S, Troendle JF, Lederman RJ. Transcaval Access and Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation. J Am Coll Cardiol. 2017 Feb 7;69(5):511-521. doi: 10.1016/j.jacc.2016.10.024. Epub 2016 Oct 29.
PubMed 27989885
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcaval Access for Transcatheter Aortic Valve Replacement in Patients With No Good Options for Aortic Access
- ClinicalTrials.gov ID
- NCT02280824
- Acronym / sponsor ID
- 999915009
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcaval, TAVR, AMPLATZER(R) Occluder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 30 Oct 2014
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 3 Nov 2014 (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.
Background:
- Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that are too small and are too sick for standard techniques. But they may benefit from a new technique called transcaval TAVR. For this technique, doctors make a hole between the largest vein (vena cava) and largest artery (aorta) in the body, inside the abdomen. Then they replace the valve through a tube they put in the groin vein. Then they close the hole between the vein and the artery using a device designed to close holes in the heart. This study tests the device for this new, off-label use.
Objective:
- To further study the safety and effectiveness of transcaval TAVR.
Eligibility:
- Adults age 21 and older who would benefit from TAVR but for whom standard techniques are not suitable.
Design:
- Participants will be selected by a team of heart specialists and others.
- Participants will have a computed tomography (CT) scan with or without contrast dye.
- Participants will have blood tests.
- Participants will have transcaval TAVR.
- Participants will receive the same standard care as for all patients with TAVR.
- Participants will also have another CT scan, or an MRI or ultrasound, before they leave the hospital, and again after about 30 days and after about 12 months.
- Participants will be contacted 1 and 6 months afterwards and will have another visit 1 year later. They will have a CT, MRI, or ultrasound. They will have blood tests and a physical exam.
Detailed description
Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) has enabled transcatheter aortic valve replacement (TAVR) in a small number of patients who have no good options for standard percutaneous femoral access or for standard surgical access to the cardiac apex or to the ascending aorta. In this prospective registry we will collect data from multiple medical centers as they offer transcaval TAVR to patients with extreme or prohibitive risk of conventional TAVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: CA-TAVR, Device: Amplatzer Duct OccluderTranscaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age greater than or equal to 21 years
- Severe symptomatic de novo aortic valve stenosis or bioprosthetic aortic valve failure for which transcatheter aortic valve replacement (TAVR) is felt beneficial according to the consensus of the institutional multidisciplinary heart team
- Extreme risk or inoperability for TAVR via conventional femoral artery, trans-apical, or trans-aortic access in the determination of the multidisciplinary heart team. This determination includes an in-person consultation by at least one cardiac surgeon member of the heart team.
- Anatomic eligibility for caval-aortic TAVR, graded as favorable or feasible based on NHLBI core lab assessment of the baseline CT examination.
Key exclusion criteria (4 listed)
- Unable or unwilling to consent to participate
- Anatomic eligibility for caval-aortic TAVR graded as unfavorable based on NHLBI core lab assessment of the baseline CT examination
- Unlikely to benefit from caval-aortic TAVR
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements.
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 |
|---|---|---|
| CA-TAVRTranscaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access | Procedure or surgery | A |
| Amplatzer Duct Occluder | Device | A |
Primary outcome
The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access
Time frame: 1 year
The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access
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 15 Feb 2019.
- Background: PubMed 20961243Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
- Background: PubMed 21639811Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
- Background: PubMed 24814495Greenbaum AB, O'Neill WW, Paone G, Guerrero ME, Wyman JF, Cooper RL, Lederman RJ. Caval-aortic access to allow transcatheter aortic valve replacement in otherwise ineligible patients: initial human experience. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2795-804. doi: 10.1016/j.jacc.2014.04.015. Epub 2014 May 7.
- Background: PubMed 23500317Halabi M, Ratnayaka K, Faranesh AZ, Chen MY, Schenke WH, Lederman RJ. Aortic access from the vena cava for large caliber transcatheter cardiovascular interventions: pre-clinical validation. J Am Coll Cardiol. 2013 Apr 23;61(16):1745-6. doi: 10.1016/j.jacc.2013.01.057. Epub 2013 Apr 2. No abstract available.
- Derived from this study: PubMed 30846083Lederman RJ, Babaliaros VC, Rogers T, Stine AM, Chen MY, Muhammad KI, Leonardi RA, Paone G, Khan JM, Leshnower BG, Thourani VH, Tian X, Greenbaum AB. The Fate of Transcaval Access Tracts: 12-Month Results of the Prospective NHLBI Transcaval Transcatheter Aortic Valve Replacement Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):448-456. doi: 10.1016/j.jcin.2018.11.035.
- Derived from this study: PubMed 27989885Greenbaum AB, Babaliaros VC, Chen MY, Stine AM, Rogers T, O'Neill WW, Paone G, Thourani VH, Muhammad KI, Leonardi RA, Ramee S, Troendle JF, Lederman RJ. Transcaval Access and Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation. J Am Coll Cardiol. 2017 Feb 7;69(5):511-521. doi: 10.1016/j.jacc.2016.10.024. Epub 2016 Oct 29.
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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.
Robert J Lederman, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CA-TAVR and Amplatzer Duct Occluder in people with Aortic Valve Stenosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 15 sites 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 4 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access (time frame: 1 year). 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 NCT02280824, which also lists 6 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 15 Feb 2019.