Aortic Valve StenosisBALANCENCT07794306
Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic Annuli
A study testing Meril Octapro+ THV System and Abbott Navitor/Navitor Vision THV system in people with Aortic Valve Stenosis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
In Europe TAVI is now recommended for treatment of aortic valve stenosis from the age of 70 years. When performing TAVI in young patients, lifetime management becomes important in terms of anticipated TAVI-in-TAVI procedures when valve deterioration occures. 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?
- Meril Octapro+ THV System and Abbott Navitor/Navitor Vision THV system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteGermany
- Study dates
- 26 Oct 2026to 31 Dec 2033
- 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
- Participants 18 years of age or older
- Heart team consensus that isolated transfemoral TAVI is medically justified and advisable
- Diagnosis of severe symptomatic aortic valve stenosis and aortic annulus ≤ 430 mm² as seen in preoperative CT diagnostic
- Anatomy is suitable for both BE and SE THVs according to Heart Team judgement
- Participant provided written informed consent to participate in the trial
- Ability of participant to understand patient information and to personally sign and date informed consent to participate in trial, before performing any trial-related procedures
- Participant and treating physician agree that participant will return for all required postprocedural follow-up visits
Who cannot join
- Uni- or bicuspid aortic valve pathology
- Severe Left ventricular outflow tract (LVOT) calcification with prohibitive risk for BE THV as determined by heart team
- Non-calcified aortic valve pathology or endocarditis
- Expected life expectancy <12 months due to associated non-cardiac comorbidities
- Currently participating in another investigational drug or device trial
- Urgent or emergency TAVI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Medical Center Hamburg-Eppendorf (UKE), University Heart and Vascular Center Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 20249
Andreas Schaefer, PD Dr. med., +4915222816250, and.schaefer@uke.de
About this study
In Europe TAVI is now recommended for treatment of aortic valve stenosis from the age of 70 years. When performing TAVI in young patients, lifetime management becomes important in terms of anticipated TAVI-in-TAVI procedures when valve deterioration occures. Especially small aortic annuli represent a special challenge in terms of postprocedural hemodynamics, however intra-annular transcatheter heart valve designs should be the devices of choice to facilitate future TAVI-in-TAVI procedures. Which intra-annular valve design offers ideal clinical and hemodynamic efficacy is unclear. Therefore, an investigator-initiated, randomized controlled trial (BALANCE trial: Balloon- vs. Self-expanding intraannular TAVI in small aortic annuli) was created to elucidate this topic.
Read the detailed description
This is a prospective, multi-center, national, randomized controlled, post-market trial.
The primary objectives of the trial are to demonstrate clinical and hemodynamic non-inferiority of the Octapro+ System when compared to subjects treated with the Navitor System at 30 days and12 months post-procedure.
Subjects will be randomized on a 2:1 basis to receive TAVI with either a Meril Balloon-expanding (BE) intraannular Transcatheter Heart Valve (THV) or an Abbott Self-expanding (SE) intraannular THV. Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed.
Product Names:
- Meril Octapro+ THV System, (Commercially available in Germany)
- Abbott Navitor/ Navitor Vision THV System (Commercially available in Europe/US.)
Currently, there is no comparative evidence for clinical and hemodynamic efficacy of the two available intra-annular THV principles (BE vs. SE) for treatment of AS in patients with small aortic annuli.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Meril Octapro+ THV System, Abbott Navitor/Navitor Vision THV system
- Keywords
- TAVI, TAVR, Aortic valve stenosis, Bioprostheses, Transcatheter Heart Valves, Balloon-expanding, Self-expanding, Aortic annulus, Hemodynamics
- 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.
Meril Octapro+ THV SystemDevice
Also called Transcatheter aortic valve replacement
TAVI treatment with Meril Octapro+ THV System
Abbott Navitor/Navitor Vision THV systemDevice
Also called Transcatheter aortic valve replacement
TAVI treatment with Abbott Navitor/Navitor Vision System
| Study group | Role | What they receive |
|---|---|---|
| Intra-annular Balloon-expanding THV | Experimental | Not described Receives: Device: Meril Octapro+ THV System |
| Intra-annular Self-expanding THV | Experimental | Not described Receives: Device: Abbott Navitor/Navitor Vision THV system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Safety according to VARC-3 Criteria
- Freedom from all-cause mortality
- Freedom from all stroke
- Freedom from VARC type 2-4 bleeding
- Freedom from major vascular, access-related, or cardiac structural complication
- Freedom from acute kidney injury stage 3 or 4
- Freedom from moderate or severe aortic regurgitation
- Freedom from new permanent pacemaker due to procedure-related conduction abnormalities
- Freedom from surgery or intervention related to the device
Measured: 30 Days
Secondary outcomes (12)
Hemodynamic performance (Mean aortic gradient)
- Transvalvular mean pressure gradient ( mmHg, Continuous Variable)
Measured: 12 Months and 5 Years
Paravalvular leakage ≥ moderate
Rate of significant paravalvular leakage (≥ moderate)
Measured: 12 months and 5 years
Freedom from All-cause mortality, Disabling stroke and Rehospitalization
Composite Endpoint
Measured: 5 Years
Rate of Bioprosthetic valve failure and dysfunction (Combined endpoint)
- Valve mean gradient of 20 mm Hg or higher
- Incidence of Nonstructural valve dysfunction, defined as severe prosthesis-patient mismatch or at least moderate aortic regurgitation
- Incidence of Clinical valve thrombosis; endocarditis
- Incidence of Aortic-valve reintervention
Measured: 5 Years
Rate of Permanent Pacemaker Implantation
Implantation of a Permanent Pacemaker due to Conduction disturbances
Measured: 5 Years
Rate of Any Stroke
Minor, Major and Disabling Stroke
Measured: 5 Years
New York Heart Association functional class compared to baseline
Symptom relief (Dyspnea)
Measured: 5 Years
Left ventricular ejection fraction compared to baseline
Left Ventricular Function parameter
Measured: 5 Years
Length of hospital stay at discharge
Length of hospital stay at discharge
Measured: 30 Days
Technical success according to VARC-3 criteria
- Freedom from mortality
- Successful access, delivery of device and retrieval of the delivery system
- Correct positioning of a single prosthetic heart valve into the proper anatomical location
- Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Measured: 30 Days
Device success according to VARC-3 criteria
- Technical success
- Freedom from mortality
- Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
- Intended performance of the valve (mean gradient < 20 mm Hg, peak velocity < 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation
Measured: 30 Days
Rate of New onset of atrial fibrillation or atrial flutter
New onset of atrial fibrillation or atrial flutter
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 posted31 Aug 2026
- Study start26 Oct 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Schäfer, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794306
- Sponsor's protocol ID
- UHHamburg-Eppendorf
- Acronym
- BALANCE
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic Annuli
- ClinicalTrials.gov ID
- NCT07794306
- Acronym / sponsor ID
- BALANCE / UHHamburg-Eppendorf
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVI, TAVR, Aortic valve stenosis, Bioprostheses, Transcatheter Heart Valves, Balloon-expanding, Self-expanding, Aortic annulus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 31 Aug 2026 (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.
In Europe TAVI is now recommended for treatment of aortic valve stenosis from the age of 70 years. When performing TAVI in young patients, lifetime management becomes important in terms of anticipated TAVI-in-TAVI procedures when valve deterioration occures. Especially small aortic annuli represent a special challenge in terms of postprocedural hemodynamics, however intra-annular transcatheter heart valve designs should be the devices of choice to facilitate future TAVI-in-TAVI procedures. Which intra-annular valve design offers ideal clinical and hemodynamic efficacy is unclear. Therefore, an investigator-initiated, randomized controlled trial (BALANCE trial: Balloon- vs. Self-expanding intraannular TAVI in small aortic annuli) was created to elucidate this topic.
Detailed description
This is a prospective, multi-center, national, randomized controlled, post-market trial.
The primary objectives of the trial are to demonstrate clinical and hemodynamic non-inferiority of the Octapro+ System when compared to subjects treated with the Navitor System at 30 days and12 months post-procedure.
Subjects will be randomized on a 2:1 basis to receive TAVI with either a Meril Balloon-expanding (BE) intraannular Transcatheter Heart Valve (THV) or an Abbott Self-expanding (SE) intraannular THV. Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed.
Product Names:
- Meril Octapro+ THV System, (Commercially available in Germany)
- Abbott Navitor/ Navitor Vision THV System (Commercially available in Europe/US.)
Currently, there is no comparative evidence for clinical and hemodynamic efficacy of the two available intra-annular THV principles (BE vs. SE) for treatment of AS in patients with small aortic annuli.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-annular Balloon-expanding THV | Experimental | Device: Meril Octapro+ THV System |
| Intra-annular Self-expanding THV | Experimental | Device: Abbott Navitor/Navitor Vision THV system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants 18 years of age or older
- Heart team consensus that isolated transfemoral TAVI is medically justified and advisable
- Diagnosis of severe symptomatic aortic valve stenosis and aortic annulus ≤ 430 mm² as seen in preoperative CT diagnostic
- Anatomy is suitable for both BE and SE THVs according to Heart Team judgement
- Participant provided written informed consent to participate in the trial
Key exclusion criteria (6 listed)
- Uni- or bicuspid aortic valve pathology
- Severe Left ventricular outflow tract (LVOT) calcification with prohibitive risk for BE THV as determined by heart team
- Non-calcified aortic valve pathology or endocarditis
- Expected life expectancy <12 months due to associated non-cardiac comorbidities
- Currently participating in another investigational drug or device trial
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 |
|---|---|---|
| Meril Octapro+ THV SystemAlso: Transcatheter aortic valve replacementTAVI treatment with Meril Octapro+ THV System | Device | Intra-annular Balloon-expanding THV |
| Abbott Navitor/Navitor Vision THV systemAlso: Transcatheter aortic valve replacementTAVI treatment with Abbott Navitor/Navitor Vision System | Device | Intra-annular Self-expanding THV |
Primary outcome
Early Safety according to VARC-3 Criteria
Time frame: 30 Days
* Freedom from all-cause mortality * Freedom from all stroke * Freedom from VARC type 2-4 bleeding * Freedom from major vascular, access-related, or cardiac structural complication * Freedom from acute kidney injury stage 3 or 4 * Freedom from moderate or severe aortic regurgitation * Freedom from new permanent pacemaker due to procedure-related conduction abnormalities * Freedom from surgery or intervention related to the device
12 secondary outcomes
Hemodynamic performance (Mean aortic gradient)
Time frame: 12 Months and 5 Years
Paravalvular leakage ≥ moderate
Time frame: 12 months and 5 years
Freedom from All-cause mortality, Disabling stroke and Rehospitalization
Time frame: 5 Years
Rate of Bioprosthetic valve failure and dysfunction (Combined endpoint)
Time frame: 5 Years
Rate of Permanent Pacemaker Implantation
Time frame: 5 Years
Rate of Any Stroke
Time frame: 5 Years
New York Heart Association functional class compared to baseline
Time frame: 5 Years
Left ventricular ejection fraction compared to baseline
Time frame: 5 Years
Length of hospital stay at discharge
Time frame: 30 Days
Technical success according to VARC-3 criteria
Time frame: 30 Days
Device success according to VARC-3 criteria
Time frame: 30 Days
Rate of New onset of atrial fibrillation or atrial flutter
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 31 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meril Octapro+ THV System and Abbott Navitor/Navitor Vision THV system in people with Aortic Valve Stenosis, run by Universitätsklinikum Hamburg-Eppendorf 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 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: opening soon, as of the sponsor's last update on 31 Aug 2026. 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?
Contact Andreas Schaefer, PD Dr. med. (+4915222816250, and.schaefer@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Safety according to VARC-3 Criteria (time frame: 30 Days). 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 31 Aug 2026.