Aortic RegurgitationALIGN-ARNCT04415047
The JenaValve ALIGN-AR Pivotal Trial
A study testing JenaValve Trilogy Heart Valve System in people with Aortic Regurgitation and Aortic Valve Insufficiency, run by JenaValve Technology, Inc. at 30 sites in United States.
Trial summary
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- What is being tested?
- JenaValve Trilogy Heart Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 30 sitesUnited States
- Study dates
- 22 May 2020to Aug 2028
- Phase
- Interventional
- 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
Who may be able to join
- Patient with severe aortic regurgitation (AR).
- Patient at high risk for open surgical valve replacement
- Patient symptomatic according to NYHA functional class II or higher
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.
Who cannot join
- Congenital uni or bicuspid aortic valve morphology
- Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
- Endocarditis or other active infection
- Need for urgent or emergent TAVR procedure for any reason
- Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
- Severe mitral regurgitation
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont Healthcare
Atlanta, Georgia, 30309
Emory University Hospital
Atlanta, Georgia, 30322
University of Maryland Medical Center
Baltimore, Maryland, 21201
Medical University of South Carolina
Charleston, South Carolina, 29425
The Christ Hospital
Cincinnati, Ohio, 45219
Morton Plant/ BayCare Health
Clearwater, Florida, 33756
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio Health Research Institute
Columbus, Ohio, 43214
Baylor Scott & White Research Institute
Dallas, Texas, 75201
Henry Ford Health System
Detroit, Michigan, 48202
Houston Methodist
Houston, Texas, 77030
Memorial Hermann - Texas Medical Center
Houston, Texas, 77030
Cedars Sinai Medical Center
Los Angeles, California, 90048
Methodist Le Bonheur Healthcare
Memphis, Tennessee, 38104
Minneapolis Heart Institute/ Abbott Northwestern
Minneapolis, Minnesota, 55407
New York-Presbyterian/ Columbia University Medical Center
New York, New York, 10032
Sentara Hospitals
Norfolk, Virginia, 23502
Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health
Oak Lawn, Illinois, 60453
Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital
Piscataway, New Jersey, 08901
Allegheny-Singer Health Network
Pittsburgh, Pennsylvania, 15212
Oregon Health & Science University
Portland, Oregon, 97239
Intermountain Medical Center Heart Institute
Salt Lake City, Utah, 84111
Scripps Hospital
San Diego, California, 92121
California Pacific Medical Center Research Institute
San Francisco, California, 94109
University of Washington
Seattle, Washington, 98195
Barnes-Jewish Hospital / Washington University
St Louis, Missouri, 63110
TMC HealthCare & PIMA Heart
Tucson, Arizona, 85712
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Lankenau
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
Read the detailed description
This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat symptomatic severe aortic regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Being tested
- JenaValve Trilogy Heart Valve System
- Keywords
- Valvular Heart Disease, Aortic Incompetence, Aortic Valve Incompetence
- Medical subject headings
- Aortic Valve Insufficiency, Aortic Valve Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JenaValve Trilogy Heart Valve SystemDevice
TAVR with JenaValve Trilogy Heart Valve System
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Experimental | TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System Receives: Device: JenaValve Trilogy Heart Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality at 1 Year
All-cause mortality within the first 12 months post index procedure
Measured: 1 year
All Stroke
Number of patients that had a stroke
Measured: 30 days
Major Bleeding
Number of patients that had any of these events
Measured: 30 days
Acute Kidney Injury
Number of patients that had these events
Measured: 30 days
Major Vascular Complications
Number of patients that had these events
Measured: 30 days
Surgery/intervention related to the device
Number of patients that had these events
Measured: 30 days
Permanent pacemaker implantation
Number of patients that had these events
Measured: 30 days
Total aortic regurgitation
Number of patients that had these events
Measured: 30 days
Secondary outcomes (1)
KCCQ
KCCQ Improvement
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 posted4 Jun 2020
- Study start22 May 2020
- Primary completion29 Aug 2023 (estimated)
- Study completionAug 2028 (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 RegurgitationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- JenaValve Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin B. Leon, MD, Study chair, New York-Presbyterian/ Columbia University Medical CenterTorsten P. Vahl, MD, Principal investigator, New York-Presbyterian/ Columbia University Medical CenterVinod H. Thourani, MD, Principal investigator, Piedmont Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415047
- Sponsor's protocol ID
- P02C320
- Acronym
- ALIGN-AR
- Status last verified
- Sep 2022
- First submitted
- 31 May 2020
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.
PubMed 28314623Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Jun 20;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503. Epub 2017 Mar 15. No abstract available.
PubMed 28298458Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.
PubMed 12831818Geyer M, Tamm AR, Munzel T, Treede H, von Bardeleben RS. Novel Transfemoral TAVR System to Treat Aortic Regurgitation in Degenerated Surgical Aortic Valve Replacement Even in Unfavorable Anatomy. JACC Cardiovasc Interv. 2022 Jun 13;15(11):e135-e136. doi: 10.1016/j.jcin.2022.02.043. Epub 2022 May 11. No abstract available.
PubMed 35568645Poschner T, Werner P, Kocher A, Laufer G, Musumeci F, Andreas M, Russo M. The JenaValve pericardial transcatheter aortic valve replacement system to treat aortic valve disease. Future Cardiol. 2022 Feb;18(2):101-113. doi: 10.2217/fca-2021-0065. Epub 2021 Oct 14.
PubMed 34647465Ng VG, Khalique OK, Nazif T, Patel A, Hamid N, George I, Bapat V, Hahn R, Kodali S, Vahl TP. Treatment of Acute Aortic Insufficiency With a Dedicated Device. JACC Case Rep. 2021 Mar 24;3(4):645-649. doi: 10.1016/j.jaccas.2021.01.021. eCollection 2021 Apr.
PubMed 34317595Tang RS, Li YM, Bao Y, Zeng JD, Yao YJ, Wang JY, Yang XY, Xu YJ, Pu XZ, Jiang WL, Jia YH, Yin Y, Li H, Li W, Yi Z, Chen M. Development of a multi-label deep neural network model for predicting immediate paravalvular leakage and new-onset conduction disturbances after transcatheter aortic valve replacement: A retrospective cohort study. Digit Health. 2026 Mar 31;12:20552076261427502. doi: 10.1177/20552076261427502. eCollection 2026 Jan-Dec.
PubMed 41928824Makkar RR, Thourani VH, Vahl TP, Yadav PK, McCabe JM, George I, Satler L, Chetcuti S, Daniels DV, Waggoner T, Whisenant B, Russo M, Summers M, Garcia S, Frisoli T, Ramana RK, Stinis C, Golwala H, Zahr F, Greenbaum A, Rovin J, Sanchez C, Szerlip M, Deeb GM, Amoroso N, Patel D, Fahy M, Ranard LS, Gupta A, Chakravarty T, Skaf S, Chuang M, Kodali SK, Figulla HR, Treede H, Baldus S, Pinto DS, Leon MB; ALIGN-AR Investigators. Transcatheter aortic valve implantation with the Trilogy valve for symptomatic native aortic regurgitation (ALIGN-AR): a pivotal, multicentre, single-arm, investigational device exemption study. Lancet. 2025 Dec 13;406(10521):2757-2771. doi: 10.1016/S0140-6736(25)02215-9. Epub 2025 Nov 16.
PubMed 41260228Vahl TP, Thourani VH, Makkar RR, Hamid N, Khalique OK, Daniels D, McCabe JM, Satler L, Russo M, Cheng W, George I, Aldea G, Sheridan B, Kereiakes D, Golwala H, Zahr F, Chetcuti S, Yadav P, Kodali SK, Treede H, Baldus S, Amoroso N, Ranard LS, Pinto DS, Leon MB. Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study. Lancet. 2024 Apr 13;403(10435):1451-1459. doi: 10.1016/S0140-6736(23)02806-4. Epub 2024 Mar 26.
PubMed 38552656Hamid N, Ranard LS, Khalique OK, Hahn RT, Nazif TM, George I, Ng V, Leon MB, Kodali SK, Vahl TP. Commissural Alignment After Transfemoral Transcatheter Aortic Valve Replacement With the JenaValve Trilogy System. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2079-2081. doi: 10.1016/j.jcin.2021.07.025. No abstract available.
PubMed 34556282
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)
- ClinicalTrials.gov ID
- NCT04415047
- Acronym / sponsor ID
- ALIGN-AR / P02C320
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Keywords
- Valvular Heart Disease, Aortic Incompetence, Aortic Valve Incompetence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- JenaValve Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 May 2020 (actual)
- Primary completion
- 29 Aug 2023 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 4 Jun 2020 (actual)
- 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.
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
Detailed description
This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat symptomatic severe aortic regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Experimental | Device: JenaValve Trilogy Heart Valve SystemTAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with severe aortic regurgitation (AR).
- Patient at high risk for open surgical valve replacement
- Patient symptomatic according to NYHA functional class II or higher
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.
Key exclusion criteria (6 listed)
- Congenital uni or bicuspid aortic valve morphology
- Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
- Endocarditis or other active infection
- Need for urgent or emergent TAVR procedure for any reason
- Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
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 |
|---|---|---|
| JenaValve Trilogy Heart Valve SystemTAVR with JenaValve Trilogy Heart Valve System | Device | Transcatheter Aortic Valve Replacement (TAVR) |
Primary outcome
All-Cause Mortality at 1 Year
Time frame: 1 year
All-cause mortality within the first 12 months post index procedure
All Stroke
Time frame: 30 days
Number of patients that had a stroke
Major Bleeding
Time frame: 30 days
Number of patients that had any of these events
Acute Kidney Injury
Time frame: 30 days
Number of patients that had these events
Major Vascular Complications
Time frame: 30 days
Number of patients that had these events
Surgery/intervention related to the device
Time frame: 30 days
Number of patients that had these events
Permanent pacemaker implantation
Time frame: 30 days
Number of patients that had these events
Total aortic regurgitation
Time frame: 30 days
Number of patients that had these events
1 secondary outcome
KCCQ
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 13 Sep 2022.
- Background: PubMed 28314623Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.
- Background: PubMed 28298458Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Jun 20;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503. Epub 2017 Mar 15. No abstract available.
- Background: PubMed 12831818Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.
- Background: PubMed 35568645Geyer M, Tamm AR, Munzel T, Treede H, von Bardeleben RS. Novel Transfemoral TAVR System to Treat Aortic Regurgitation in Degenerated Surgical Aortic Valve Replacement Even in Unfavorable Anatomy. JACC Cardiovasc Interv. 2022 Jun 13;15(11):e135-e136. doi: 10.1016/j.jcin.2022.02.043. Epub 2022 May 11. No abstract available.
- Background: PubMed 34647465Poschner T, Werner P, Kocher A, Laufer G, Musumeci F, Andreas M, Russo M. The JenaValve pericardial transcatheter aortic valve replacement system to treat aortic valve disease. Future Cardiol. 2022 Feb;18(2):101-113. doi: 10.2217/fca-2021-0065. Epub 2021 Oct 14.
- Background: PubMed 34317595Ng VG, Khalique OK, Nazif T, Patel A, Hamid N, George I, Bapat V, Hahn R, Kodali S, Vahl TP. Treatment of Acute Aortic Insufficiency With a Dedicated Device. JACC Case Rep. 2021 Mar 24;3(4):645-649. doi: 10.1016/j.jaccas.2021.01.021. eCollection 2021 Apr.
- Derived from this study: PubMed 41928824Tang RS, Li YM, Bao Y, Zeng JD, Yao YJ, Wang JY, Yang XY, Xu YJ, Pu XZ, Jiang WL, Jia YH, Yin Y, Li H, Li W, Yi Z, Chen M. Development of a multi-label deep neural network model for predicting immediate paravalvular leakage and new-onset conduction disturbances after transcatheter aortic valve replacement: A retrospective cohort study. Digit Health. 2026 Mar 31;12:20552076261427502. doi: 10.1177/20552076261427502. eCollection 2026 Jan-Dec.
- Derived from this study: PubMed 41260228Makkar RR, Thourani VH, Vahl TP, Yadav PK, McCabe JM, George I, Satler L, Chetcuti S, Daniels DV, Waggoner T, Whisenant B, Russo M, Summers M, Garcia S, Frisoli T, Ramana RK, Stinis C, Golwala H, Zahr F, Greenbaum A, Rovin J, Sanchez C, Szerlip M, Deeb GM, Amoroso N, Patel D, Fahy M, Ranard LS, Gupta A, Chakravarty T, Skaf S, Chuang M, Kodali SK, Figulla HR, Treede H, Baldus S, Pinto DS, Leon MB; ALIGN-AR Investigators. Transcatheter aortic valve implantation with the Trilogy valve for symptomatic native aortic regurgitation (ALIGN-AR): a pivotal, multicentre, single-arm, investigational device exemption study. Lancet. 2025 Dec 13;406(10521):2757-2771. doi: 10.1016/S0140-6736(25)02215-9. Epub 2025 Nov 16.
- Derived from this study: PubMed 38552656Vahl TP, Thourani VH, Makkar RR, Hamid N, Khalique OK, Daniels D, McCabe JM, Satler L, Russo M, Cheng W, George I, Aldea G, Sheridan B, Kereiakes D, Golwala H, Zahr F, Chetcuti S, Yadav P, Kodali SK, Treede H, Baldus S, Amoroso N, Ranard LS, Pinto DS, Leon MB. Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study. Lancet. 2024 Apr 13;403(10435):1451-1459. doi: 10.1016/S0140-6736(23)02806-4. Epub 2024 Mar 26.
- Derived from this study: PubMed 34556282Hamid N, Ranard LS, Khalique OK, Hahn RT, Nazif TM, George I, Ng V, Leon MB, Kodali SK, Vahl TP. Commissural Alignment After Transfemoral Transcatheter Aortic Valve Replacement With the JenaValve Trilogy System. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2079-2081. doi: 10.1016/j.jcin.2021.07.025. No abstract available.
- Individual participant dataSharing planned: No
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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.
Martin B. Leon, MD study chair
New York-Presbyterian/ Columbia University Medical Center
Torsten P. Vahl, MD principal investigator
New York-Presbyterian/ Columbia University Medical Center
Vinod H. Thourani, MD principal investigator
Piedmont Healthcare
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JenaValve Trilogy Heart Valve System in people with Aortic Regurgitation and Aortic Valve Insufficiency, run by JenaValve Technology, Inc. at 30 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 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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.
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?
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?
All-Cause Mortality at 1 Year (time frame: 1 year). The study lists 8 primary outcomes in all. 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 NCT04415047, 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 13 Sep 2022.