Aortic Valve StenosisREBOOT-PARADOXNCT03863132
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
A study testing TAVR in people with Aortic Valve Stenosis, run by IHF GmbH - Institut für Herzinfarktforschung at 1 site in Germany.
Trial summary
Aim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis. 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?
- TAVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jul 2019to 1 Mar 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
- I1. Patients with symptomatic native aortic valve stenosis and age ≥18 years
- I2. Aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2, mean aortic gradient < 40 mmHg and stroke volume index (SVI) < 35ml/m2
- I3. Left ventricular ejection fraction ≥ 50%
- I4. MDCT aortic valve calcium score men > 2000AU, women > 1200AU OR the likelihood criteria are fulfilled (symptoms without other explanation and LV hypertrophy; age < 70 yrs., AVS < 0.8 cm2; SVI < 35ml/m2 confirmed by 3D TOE, MRI or invasive; reduced LV longitudinal function without other reason)
- I5. Heart team agrees on eligibility for TAVR
- I6. Written informed consent
- I7. Negative pregnancy test in women with childbearing potential
Who cannot join
- E1. Hemodynamic instability
- E2. Cardiogenic shock
- E3. Pre-existing mechanical or bio-prosthetic valve in any position
- E4. Concomitant severe valvular heart disease
- E5. Pre-existing or active endocarditis
- E6. Need for heart surgery due to other conditions
Show all 14Show fewer
- E7. Aortic valve is congenital unicuspid or congenital bicuspid
- E8. Hypertrophic cardiomyopathy with or without obstruction
- E9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- E10. Acute myocardial infarction within 1 month before intended AS-treatment
- E11. Renal replacement therapy
- E12. Estimated life expectancy < 24 months (730 days) due to carcinomas end stage liver disease or renal disease
- E13. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- E14. Patient refuses aortic valve repair
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum der Universität München-Großhadern
München, Bavaria, 81377
About this study
Official title: Optimal Medical Treatment With or Without Valve Repair in Patients With Symptomatic Paradoxical Low-Flow, Low-Gradient Aortic Stenosis - a Multi-center, Randomized Comparison
Aim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.
Read the detailed description
Stenosis of the aortic valve leads to a narrowing of the valve, consequently to low blood flow from the heart into the Aorta, and is associated with symptoms like fatigue, breathlessness, dizziness, fainting, and chest pain. For many of the patients suffering from severe aortic stenosis surgical or catheter-assisted repair or replacement of the damaged aortic valve has been proven to be a safe and effective treatment option.
Probably about 20-30% of patients suffering from severe aortic stenosis display a deviation from the usually observed disease pattern: These patients do not show the typical high pressure difference between the left ventricle (heart chamber) and the aorta (transvalvular gradient; "paradoxical" low flow/low gradient aortic stenosis). For these patients it is not yet clear, if microsurgical repair of the aortic valve (transcatheter aortic valve repair - TAVR) should be a treatment option as well.
REBOOT-PARADOX evaluates whether TAVR is advantageous compared to optimal medical Treatment alone for patients suffering from paradoxical aortic stenosis. Two thirds of the participating patients will be treated by TAVR, one third will receive medical Treatment alone.
- Conditions
- Aortic Valve Stenosis
- Being tested
- TAVR
- Keywords
- Aortic stenosis, Low flow, Low gradient, Transcatheter 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.
TAVRDevice
Repair of defective aortic valve by microsurgical Intervention.
| Study group | Role | What they receive |
|---|---|---|
| TAVR Group | Active comparator | Patients will be treated by transcatheter aortic valve repair (TAVR). Receives: Device: TAVR |
| Medical Treatment Group | No intervention | Patients will receive optimal medical treatment alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death
All-cause mortality
Measured: 24 months after last-patient-in
Secondary outcomes (8)
Cardiovascular mortality
Death because of cardiovascular events
Measured: 5 years after index treatment
Re-hospitalization due to heart failure
Number of hospital stays after randomization
Measured: 5 years after index treatment
Incidence of neurological events - incidence of strokes
Number of strokes
Measured: 5 years after randomization
Incidence of neurological Events - incidence of transient ischaemic attacks
Number of transient ischaemic attacks
Measured: 5 years after randomization
Cardiac functionality - left ventricular function
Echocardiographic measurement of left ventricular ejection fraction in %
Measured: 5 years after randomization
Cardiac functionality - aortic valve hemodynamics
Measurement of aortic pressure in mmHg
Measured: 5 years after randomization
Patients' quality of life
EQ5D-score in %
Measured: 5 years after randomization
Device reliability
Number of reinterventions (TAVR arm only)
Measured: 5 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start3 Jul 2019
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Mar 2028 (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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, controlled, randomized (2:1), parallel group, open-label, multi-centre, international
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation, Yale University
- Responsible party
- Sponsor
- Investigators
- Julinda Mehilli, Prof. Dr., Principal investigator, University Clinic Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863132
- Sponsor's protocol ID
- REBOOT-PARADOX
- Acronym
- REBOOT-PARADOX
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2019
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehilli J, Steffen J, Rudolph T, Haum M, Giannini C, Stark K, Ince H, Conradi L, Joner M, Schafer A, Karcher AK, Landt M, Adam M, Thiele H, Geisler T, Jochheim D, Hagl C, Zeymer U, Windecker S, Massberg S; REBOOT-PARADOX-Trial Investigators. Transcatheter Aortic Valve Replacement or Medical Treatment for Paradoxical Low-Flow, Low-Gradient Aortic Valve Stenosis: REBOOT-PARADOX. J Am Coll Cardiol. 2026 Aug 28:S0735-1097(26)07496-6. doi: 10.1016/j.jacc.2026.08.017. Online ahead of print.
PubMed 42663358
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Medical Treatment With or Without Valve Repair in Patients With Symptomatic Paradoxical Low-Flow, Low-Gradient Aortic Stenosis - a Multi-center, Randomized Comparison
- ClinicalTrials.gov ID
- NCT03863132
- Acronym / sponsor ID
- REBOOT-PARADOX / REBOOT-PARADOX
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic stenosis, Low flow, Low gradient, Transcatheter aortic valve replacement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- IHF GmbH - Institut für HerzinfarktforschungUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation, Yale University
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 5 Mar 2019 (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.
Aim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.
Detailed description
Stenosis of the aortic valve leads to a narrowing of the valve, consequently to low blood flow from the heart into the Aorta, and is associated with symptoms like fatigue, breathlessness, dizziness, fainting, and chest pain. For many of the patients suffering from severe aortic stenosis surgical or catheter-assisted repair or replacement of the damaged aortic valve has been proven to be a safe and effective treatment option.
Probably about 20-30% of patients suffering from severe aortic stenosis display a deviation from the usually observed disease pattern: These patients do not show the typical high pressure difference between the left ventricle (heart chamber) and the aorta (transvalvular gradient; "paradoxical" low flow/low gradient aortic stenosis). For these patients it is not yet clear, if microsurgical repair of the aortic valve (transcatheter aortic valve repair - TAVR) should be a treatment option as well.
REBOOT-PARADOX evaluates whether TAVR is advantageous compared to optimal medical Treatment alone for patients suffering from paradoxical aortic stenosis. Two thirds of the participating patients will be treated by TAVR, one third will receive medical Treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, controlled, randomized (2:1), parallel group, open-label, multi-centre, international
| Arm | Type | Receives |
|---|---|---|
| TAVR Group | Active comparator | Device: TAVRPatients will be treated by transcatheter aortic valve repair (TAVR). |
| Medical Treatment Group | No intervention | –Patients will receive optimal medical treatment alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- I1. Patients with symptomatic native aortic valve stenosis and age ≥18 years
- I2. Aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2, mean aortic gradient < 40 mmHg and stroke volume index (SVI) < 35ml/m2
- I3. Left ventricular ejection fraction ≥ 50%
- I4. MDCT aortic valve calcium score men > 2000AU, women > 1200AU OR the likelihood criteria are fulfilled (symptoms without other explanation and LV hypertrophy; age < 70 yrs., AVS < 0.8 cm2; SVI < 35ml/m2 confirmed by 3D TOE, MRI or invasive; reduced LV longitudinal function without other reason)
- I5. Heart team agrees on eligibility for TAVR
Key exclusion criteria (14 listed)
- E1. Hemodynamic instability
- E2. Cardiogenic shock
- E3. Pre-existing mechanical or bio-prosthetic valve in any position
- E4. Concomitant severe valvular heart disease
- E5. Pre-existing or active endocarditis
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 |
|---|---|---|
| TAVRRepair of defective aortic valve by microsurgical Intervention. | Device | TAVR Group |
Primary outcome
Time to death
Time frame: 24 months after last-patient-in
All-cause mortality
8 secondary outcomes
Cardiovascular mortality
Time frame: 5 years after index treatment
Re-hospitalization due to heart failure
Time frame: 5 years after index treatment
Incidence of neurological events - incidence of strokes
Time frame: 5 years after randomization
Incidence of neurological Events - incidence of transient ischaemic attacks
Time frame: 5 years after randomization
Cardiac functionality - left ventricular function
Time frame: 5 years after randomization
Cardiac functionality - aortic valve hemodynamics
Time frame: 5 years after randomization
Patients' quality of life
Time frame: 5 years after randomization
Device reliability
Time frame: 5 years after randomization
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 4 May 2025.
- Derived from this study: PubMed 42663358Mehilli J, Steffen J, Rudolph T, Haum M, Giannini C, Stark K, Ince H, Conradi L, Joner M, Schafer A, Karcher AK, Landt M, Adam M, Thiele H, Geisler T, Jochheim D, Hagl C, Zeymer U, Windecker S, Massberg S; REBOOT-PARADOX-Trial Investigators. Transcatheter Aortic Valve Replacement or Medical Treatment for Paradoxical Low-Flow, Low-Gradient Aortic Valve Stenosis: REBOOT-PARADOX. J Am Coll Cardiol. 2026 Aug 28:S0735-1097(26)07496-6. doi: 10.1016/j.jacc.2026.08.017. Online ahead of print.
- 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.
Julinda Mehilli, Prof. Dr. principal investigator
University Clinic Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR in people with Aortic Valve Stenosis, run by IHF GmbH - Institut für Herzinfarktforschung at 1 site in Germany.
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 14 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 4 May 2025. 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 Germany. 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?
Time to death (time frame: 24 months after last-patient-in). 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 NCT03863132, 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 4 May 2025.