All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve

NCT05989074 | Unknown

• 1 other identifier: BSR-14
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis

Conditions

Aortic Stenosis, Severe

Outcome Measures

Primary Outcomes (1)

• Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.

  Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.

  At 30 Days

Secondary Outcomes (4)

• Technical success assessed by composite criteria

  Up to the end of the time when patient exit the procedure room

• Device success assessed by composite criteria

  At 30 days

• Early safety assessed by composite criteria

  At 30 days

• Clinical efficacy assessed by composite criteria

  At 1 year

Study Arms (2)

ALLEGRA

EXPERIMENTAL

ALLEGRA Delivery System TF will be administered.Patient will receive Anticoagulation medication according to the site-specific standard of care

Device: ALLEGRA TAVI System TF

Balloon-expandable TAVI

ACTIVE COMPARATOR

Patient will receive any kind of CE-marked balloon-expandable valve, and anticoagulation medication according to the site-specific standard of care

Device: Ballon-expandable valve system

Interventions

ALLEGRA TAVI System TF DEVICE

Patients receive ALLEGRA TAVI System TF. Patient will receive medication according to routine practice of the hospital

ALLEGRA

Ballon-expandable valve system DEVICE

Patients receive any kind of CE-marked balloon expandable valve system, used at the hospital. Patient will receive medication according to routine practice of the hospital.

Balloon-expandable TAVI

Eligibility Criteria

• Age: 75 Years+
• Gender Eligibility Details: Biological gender
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Female sex
• Age ≥ 75 years (according to ESC/EACTS, Guidelines for the management of valvular heart disease)
• Severe calcific aortic valve stenosis defined as follows: high-gradient aortic stenosis (mean pressure gradient across aortic valve \> 40 mmHg or peak velocity \> 4.0 m/s) Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Class ≥II
• ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus perimeter-derived average diameter \>19 mm and \<27.4 mm or area-derived diameter \>18 and \<28 mm
• Anatomy suitable for trans-femoral TAVI for both devices used in the study, including a minimum femoral diameter of 6 mm.
• Subject with a documented local Heart Team (HT) indication for TF TAVI
• Life expectancy longer than 1 year.
• Willingness to undergo clinical and echocardiographic follow-up after the procedure.
• Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow-up requirements

You may not qualify if:

• Male sex
• Non-calcific acquired aortic stenosis
• Native unicuspid/bicuspid aortic valve or congenital aortic abnormality
• Previous implantation of heart valve in any position
• Severe aortic regurgitation (\> 3+)
• Severe mitral regurgitation (\> 3+)
• Severe tricuspid regurgitation (\> 3+)
• Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) \< 30%)
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• Untreated cardiac conduction disease in need of pacemaker implantation
• Evidence of acute Myocardial Infarction (MI) less than 30 days before signing informed consent
• Any need for emergency surgery
• Any active bleeding that precludes anticoagulation
• Liver failure (Child-C)
• End-stage renal disease requiring chronic dialysis or creatinine clearance \< 30cc/min

Sponsors & Collaborators

• Ceric Sàrl: lead
• Biosensors International: collaborator
• European Cardiovascular Research Center: collaborator

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Alaide Chieffo, Prof

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

• Ignacio Cruz-Gonzalez, Prof

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nozomi Watanabe

CONTACT

+33 (0)6 61 38 94 80; nwatanabe@cerc-europe.org

Laure Morsiani

CONTACT

+33 (0)1 76 73 92 36; lmorsiani@cerc-europe.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: February 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 12, 2024

Record last verified: 2023-08