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Registry of Aortic Valve Bioprostheses Established by Catheter (FRANCE-TAVI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by French Cardiology Society
Sponsor:
Information provided by (Responsible Party):
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01777828
First received: January 25, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

Register multicenter, prospective, open, non-randomized implantation of percutaneous aortic bioprostheses through for the treatment of severe degenerative aortic stenosis Epidemiological data and the 1-year survival of aortic bioprostheses implanted by percutaneous.


Condition
Transcatheter Aortic Valve Implantation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Registry of Aortic Valve Bioprostheses Established by Catheter

Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • 1-year survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    After leaving the hospital, the doctor responsible for the register in each center will contact the patient or his family and referring physicians by phone to take new or fix an appointment for consultation. The study is purely observational, it does not require special monitoring visits but involves collecting data obtained during routine follow-up visits.


Estimated Enrollment: 5000
Study Start Date: February 2013
Estimated Study Completion Date: February 2034
Estimated Primary Completion Date: February 2033 (Final data collection date for primary outcome measure)
Groups/Cohorts
Transcatheter Aortic Valve Implantation
FRANCE TAVI registry aims to identify all patients with a change of valves implanted catheter meets the selection criteria of the technical accepting the scheduled evaluations in the context of this disease and who have agreed to participate in the study .

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients having a change of valves implanted catheter in a cardiology hospitals authorized to perform this type of installation

Criteria

Inclusion Criteria:

  1. - Existence of senile degenerative aortic stenosis with a transvalvular gradient by> 40 mmHg and / or maximum velocity> 4 m / sec and / or initial valve area <1 cm ² (indexed <0.6 cm ² / m²). The initial measurement of valve area must be obtained within 30 days prior to valve implantation
  2. - Presence of symptoms related to aortic stenosis (dyspnea, angina, syncope effort ...) demonstrated by Functional Classification for Congestive Heart Failure functional class> 2 or Class I, but with left ventricular dysfunction (ejection fraction <40% )
  3. - A Score to "EuroSCORE" (Logistic European system for cardiac operative risk evaluation) > 20% and / or Society of Thoracic Surgeons' risk Calculator> 10. In case the "EuroSCORE" <20% or STS <10, confirmed that some comorbidities were not captured by these indices will be produced by the surgeon and cardiologist

    Some patients are in a situation against medical-cardiac surgery indicates heavy although this does not appear in the predictive risk assessment through the scores. In this regard, patients may be included in the following conditions:

    3-1 - ascending aorta very calcified ("porcelain") 3-2 - Any other condition preventing cannulation for cardiopulmonary bypass, aortic clamping, or access mediastinal surgery: History of 3-2-1 against mediastinal irradiation indicating open-chest 3-2-2 thoracic deformity or history of mediastinitis-cons indicating the opening of the thorax 3-2-3 Other (eg, history of coronary bypass surgery may indicate against the opening of the thorax)

  4. - The patient accepts the scheduled evaluations at follow-up clinic
  5. - The patient or his legal representatives were informed of the nature of valve implantation and associated register and accept the conditions.

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777828

Contacts
Contact: Hervé Lebreton 33(1) 44 90 70 28 edrouet@sfcardio.fr
Contact: Geneviève Mulak 33(1) 44 90 70 28 edrouet@sfcardio.fr

Locations
France
CHU Rennes - Pontchaillou Recruiting
Rennes, France, 35000
Contact: Hervé Le Breton       edrouet@cardio-sfc.org   
Principal Investigator: Hervé Le Breton         
Sponsors and Collaborators
French Cardiology Society
Investigators
Principal Investigator: Hervé Le Breton AP