Aortic RegurgitationNCT02732704
THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
A study testing JenaValve Pericardial TAVR System in people with Aortic Regurgitation, run by JenaValve Technology, Inc. at 19 sites in 3 countries.
Trial summary
To collect information about treatment for 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
- What is being tested?
- JenaValve Pericardial TAVR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 20 Apr 2018to 29 Sep 2027
- 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
19 sites in 3 countries.
19 sites in 3 countries
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont Healthcare
Atlanta, Georgia, 30309
Emory University Hospital
Atlanta, Georgia, 30322
Baylor Scott & White Research Institute
Dallas, Texas, 75201
Cedars Sinai Medical Center
Los Angeles, California, 90048
New York-Presbyterian/ Columbia University Medical Center
New York, New York, 10032
California Pacific Medical Center Research Institute
San Francisco, California, 94109
University of Washington
Seattle, Washington, 98195
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Germany7 sites
Kerckhoff-Klinik GmbH Bad Nauheim
Bad Nauheim, 61231
Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
Bad Oeynhausen, 32545
Deutsches Herzzentrum Berlin
Berlin, 13353
Universitätsklinikum Bonn
Bonn, 53127
Herzzentrum der Universität zu Köln
Cologne, 50937
Universitätsklinikum Frankfurt
Frankfurt, 60323
Universitäres Herzzentrum Hamburg
Hamburg, 20246
Netherlands3 sites
Leiden University Medical Center
Leiden, 2333
St. Antonius Hospital
Nieuwegein, 3435
Erasmus University Medical Center
Rotterdam, 3062
About this study
Official title: THE ALIGN-AR TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Regurgitation (AR)
To collect information about treatment for 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 severe aortic regurgitation.
- Conditions
- Aortic Regurgitation
- Being tested
- JenaValve Pericardial TAVR System
- Keywords
- Aortic Valve Disease, Aortic Regurgitation, Aortic Insufficiency
- Medical subject headings
- Aortic Valve Insufficiency, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JenaValve Pericardial TAVR SystemDevice
TAVR with JenaValve Pericardial Valve and Delivery System
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Experimental | TAVR with JenaValve Pericardial Valve and Delivery System Receives: Device: JenaValve Pericardial TAVR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality at 30 days
All-Cause mortality within the first 30 days post index procedure
Measured: 30 days
Secondary outcomes (4)
Mortality
Absence of procedural mortality
Measured: At 30 days
Peri-Procedural Myocardial Infarction
Peri-procedural and spontaneous myocardial infarction
Measured: At ≤72hr after the index procedure
Stroke-Free Survival
Disabling or non-disabling stroke
Measured: At 30 days and 1 year
Bleeding & Vascular Complications
Major and minor bleeding
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study start20 Apr 2018
- Primary completion29 Aug 2022
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 100 participants (estimated)
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 HealthcareStephan Baldus, MD, Principal investigator, Herzzentrum der Universität zu Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732704
- Sponsor's protocol ID
- CP-0004
- Other IDs
- P02C320_JV06EFS_CIP, CA-0002 EU, CA-0002 Germany, CA-0011
- Status last verified
- Nov 2022
- First submitted
- 18 Mar 2016
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hamid 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 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE ALIGN-AR TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Regurgitation (AR)
- ClinicalTrials.gov ID
- NCT02732704
- Acronym / sponsor ID
- CP-0004
- Conditions
- Aortic Regurgitation
- Keywords
- Aortic Valve Disease, Aortic Regurgitation, Aortic Insufficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- JenaValve Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 11 Apr 2016 (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.
To collect information about treatment for 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 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 Pericardial TAVR SystemTAVR with JenaValve Pericardial Valve and Delivery 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 Pericardial TAVR SystemTAVR with JenaValve Pericardial Valve and Delivery System | Device | Transcatheter Aortic Valve Replacement (TAVR) |
Primary outcome
All-Cause Mortality at 30 days
Time frame: 30 days
All-Cause mortality within the first 30 days post index procedure
4 secondary outcomes
Mortality
Time frame: At 30 days
Peri-Procedural Myocardial Infarction
Time frame: At ≤72hr after the index procedure
Stroke-Free Survival
Time frame: At 30 days and 1 year
Bleeding & Vascular Complications
Time frame: 30 days
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 18 Nov 2022.
- 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
Related trials for Aortic Regurgitation
Active, not recruiting
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A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
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Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
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Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
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RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
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
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JenaValve Pericardial TAVR System in people with Aortic Regurgitation, run by JenaValve Technology, Inc. at 19 sites in 3 countries.
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 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Germany, Netherlands. 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 30 days (time frame: 30 days). 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 NCT02732704, which also lists 1 linked publication.
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 18 Nov 2022.