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

NCT07794306 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2026-08-31

No results posted yet for this study

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. 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.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Meril Octapro+ THV System

TAVI treatment with Meril Octapro+ THV System

DEVICE

Abbott Navitor/Navitor Vision THV system

TAVI treatment with Abbott Navitor/Navitor Vision System

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-26
Primary Completion
2028-07-31
Completion
2033-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07794306 on ClinicalTrials.gov