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NCT Number: NCT01777828

Registry of Aortic Valve Bioprostheses Established by Catheter

The aim of this registry is to evaluate the overall survival up to 10 years of patients with aortic valve bioprostheses implanted via the transarterial or transapical route. Data from the register is enhanced by matching it with continuous data in the SNDS.

Mandated by the French health authorities, this registry must be maintained as part of the management of any patient undergoing transarterial or transapical aortic valve bioprosthesis implantation.

Participation in the registry is offered to all subjects eligible for bioprosthesis implantation.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Rennes - Pontchaillou

Rennes, 35000, France

Location status: Recruiting

Location contact

Martine GILARD

CONTACT

[email protected]

01 44 90 70 28

Martine GILARD

PRINCIPAL_INVESTIGATOR

About this study

Aortic valve stenosis is a serious chronic life-threatening in the short or medium term since the onset of functional symptoms. Aortic valve replacement surgery is currently the treatment of choice. It is done by surgery with sternotomy and extracorporeal circulation. However, despite the considerable improvement of the conditions of care per and post operative, this procedure is sometimes burdened with high mortality, especially in the population with severe co-morbidities and / or many. For this reason, some patients are considered against the indicated surgery or high surgical risk.

The recent development of aortic valve bioprostheses implanted with new approaches (pressure or transapical) can be considered for aortic valve replacement in a population that was previously excluded.

Based on very thorough evaluation of these valves test benches and animal as well as human settlements achieved through multiple studies and registries mono or multi patients challenged by cardiac surgeons or considered at high surgical risk, it is clear that the implementation of these valves could allow, under conditions of optimal implementation and monitoring, improve short-and long-term clinical status, quality of life and prognosis of patients.

FRANCE 2 registry, established in 2010, and whose inclusions ended 30 June 2012 has allowed an initial assessment of aortic valve bioprostheses implanted catheter The following registry France 2 has been requested by the highest authorities of health, FRANCE register TAVI is performed in continuity FRANCE 2. It takes account of the first data FRANCE 2. Data Report Form has been reduced, no new item has been added, it will be carried out in all centers authorized in France to implement this technique. The collection of data will TAVI France under the same conditions as those FRANCE 2, the database will be managed by the French Society of Cardiology

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients who have undergone transarterial or transapical aortic valve bioprosthesis implantation

Exclusion criteria

Patient has not given consent

Treatment and study plan

Primary outcomes

  1. 10 year survival

    Time frame: 10 year

    After leaving the hospital, the doctor responsible for the register in each center will contact annually the patient or his family and referring physicians by phone to take new or fix an appointment for consultation. This data is supplemented by automatic collection through the SNDS link. The study is purely observational, it does not require special monitoring visits but involves collecting data obtained during routine follow-up visits.

Study contacts

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

Martine GILARD

CONTACT

[email protected]

33(1) 44 90 70 28

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: FRANCE-TAVI

Important dates

Study start
2013
Primary completion
2033
Study completion
2034
First posted
Jan 29, 2013
Registry last updated
Feb 14, 2025

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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