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NCT Number: NCT07794306

Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic Annuli

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf (UKE), University Heart and Vascular Center Hamburg

Hamburg, Free and Hanseatic City of Hamburg, 20249, Germany

Location contact

Andreas Schaefer, PD Dr. med.

CONTACT

[email protected]

+4915222816250

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Meril Octapro+ THV System

Device

TAVI treatment with Meril Octapro+ THV System

Other names: Transcatheter aortic valve replacement

Abbott Navitor/Navitor Vision THV system

Device

TAVI treatment with Abbott Navitor/Navitor Vision System

Other names: Transcatheter aortic valve replacement

Primary outcomes

  1. 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

Secondary outcomes

  1. Hemodynamic performance (Mean aortic gradient)

    Time frame: 12 Months and 5 Years

    • Transvalvular mean pressure gradient ( mmHg, Continuous Variable)

  2. Paravalvular leakage ≥ moderate

    Time frame: 12 months and 5 years

    Rate of significant paravalvular leakage (≥ moderate)

  3. Freedom from All-cause mortality, Disabling stroke and Rehospitalization

    Time frame: 5 Years

    Composite Endpoint

  4. Rate of Bioprosthetic valve failure and dysfunction (Combined endpoint)

    Time frame: 5 Years

    • 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

  5. Rate of Permanent Pacemaker Implantation

    Time frame: 5 Years

    Implantation of a Permanent Pacemaker due to Conduction disturbances

  6. Rate of Any Stroke

    Time frame: 5 Years

    Minor, Major and Disabling Stroke

  7. New York Heart Association functional class compared to baseline

    Time frame: 5 Years

    Symptom relief (Dyspnea)

  8. Left ventricular ejection fraction compared to baseline

    Time frame: 5 Years

    Left Ventricular Function parameter

  9. Length of hospital stay at discharge

    Time frame: 30 Days

    Length of hospital stay at discharge

  10. Technical success according to VARC-3 criteria

    Time frame: 30 Days

    • 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

  11. Device success according to VARC-3 criteria

    Time frame: 30 Days

    • 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

  12. Rate of New onset of atrial fibrillation or atrial flutter

    Time frame: 30 Days

    New onset of atrial fibrillation or atrial flutter

Other outcomes

  1. Freedom from All-cause mortality, Disabling stroke and Rehospitalization

    Time frame: 12 Months and 5 Years

    Composite endpoint

  2. Rate of Bioprosthetic valve failure and dysfunction (Combined endpoint)

    Time frame: 12 Months and 5 Years

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Schaefer, PD Dr. med.

CONTACT

[email protected]

+4915222816250

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Acronym: BALANCE

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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