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

NCT07794306 | Not Yet Recruiting DMC

• 1 other identifier: UHHamburg-Eppendorf
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

TAVI; TAVR; Aortic valve stenosis; Bioprostheses; Transcatheter Heart Valves; Balloon-expanding; Self-expanding; Aortic annulus; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• 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

  30 Days

Secondary Outcomes (12)

• Hemodynamic performance (Mean aortic gradient)

  12 Months and 5 Years

• Paravalvular leakage ≥ moderate

  12 months and 5 years

• Freedom from All-cause mortality, Disabling stroke and Rehospitalization

  5 Years

• Rate of Bioprosthetic valve failure and dysfunction (Combined endpoint)

  5 Years

• Rate of Permanent Pacemaker Implantation

  5 Years

Other Outcomes (2)

• Freedom from All-cause mortality, Disabling stroke and Rehospitalization

  12 Months and 5 Years

• Rate of Bioprosthetic valve failure and dysfunction (Combined endpoint)

  12 Months and 5 Years

Study Arms (2)

Intra-annular Balloon-expanding THV

EXPERIMENTAL

Device: Meril Octapro+ THV System

Intra-annular Self-expanding THV

EXPERIMENTAL

Device: Abbott Navitor/Navitor Vision THV system

Interventions

Meril Octapro+ THV System DEVICE

TAVI treatment with Meril Octapro+ THV System

Also known as: Transcatheter aortic valve replacement

Intra-annular Balloon-expanding THV

Abbott Navitor/Navitor Vision THV system DEVICE

TAVI treatment with Abbott Navitor/Navitor Vision System

Also known as: Transcatheter aortic valve replacement

Intra-annular Self-expanding THV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Andreas Schaefer, PD Dr. med.

CONTACT

+4915222816250; and.schaefer@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD. Dr. med. Andreas Schäfer, MHBA

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 31, 2026
• Study Start (Estimated): October 26, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2033
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)