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Sorin Universal REgistry on Aortic Valve Replacement (SURE-AVR)

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ClinicalTrials.gov Identifier: NCT02679404
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
LivaNova

Brief Summary:

Multi-center, International, Prospective, Non comparative, Non randomized, Open label.

5,000 patients to be enrolled approximately worldwide.

The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU).

This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.


Condition or disease
Aortic Valve Disease Aortic Stenosis

Detailed Description:

SURE-AVR objective is to collect post market safety and performance data collected along the procedure and the relevant follow-up with Sorin Group aortic valve devices in accordance with the IFU to further evidence the safety and efficacy in a post-approval environment. All current and future Sorin Group aortic valve devices that have obtained CE-mark or other local regulatory and/or commercial approvals may be included in the registry. During the duration of the registry,other aortic valve replacement products or current devices might receive modifications and might become commercial available. This registry allows extensions for the inclusion of new products.

This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry following the local applicable regulations.

The data collection shall be performed as per the local standard of care and without exposing the patient to any additional risk to the treatment (s)he would normally receive.

The registry is an open-ended project:

  • Inclusions phase: open-ended
  • Follow-up phase: annually throughout 5 years (7 and 10 years are optional).

The study shall be completed after the 10-year follow-up of the last patient.


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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sorin Universal REgistry on Aortic Valve Replacement
Study Start Date : May 2015
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2029

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Composite rate of valve related major adverse events (MAEs) [ Time Frame: At 5 years follow-up ]
    To evaluate the composite rate of site reported valve related MAE defined as death, stroke and/or re-intervention (involving surgery or any other invasive therapy) at 5 years follow-up.


Secondary Outcome Measures :
  1. Procedural timings [ Time Frame: Intra-operative and at 30 days (average) ]
    Cross clamp time, intensive care unit and total length of hospital stay.

  2. Clinical success [ Time Frame: 30 days (average) ]
    The clinical success defined as a successful valve implantation without MAE at hospital discharge.

  3. Improvement of clinical status [ Time Frame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. ]
    The improvement of clinical status defined as an improvement of at least one scale of the New York Heart Association (NYHA) classification between pre-procedure and annually throughout the duration of the registry.

  4. Echocardiographic evaluation [ Time Frame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. ]
    Performance of the device in terms of hemodynamic behavior - Effective Orifice Area (cm²), Ejection Fraction (%),Mean Aortic Gradient (mmHg), Peak Aortic Gradient (mmHg), LV mass (g) - throughout the duration of the registry.

  5. MAE during the duration of the registry [ Time Frame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. ]
    All site reported MAE rates during the duration of the registry.

  6. Composite rate of valve related MAE [ Time Frame: 4-year, and 7 and 10-year follow-up in selected centers only ]
    The composite rate of site reported valve-related MAE annually through a 4-year follow-up, and 7 and 10-year follow-up in selected centers only.

  7. Valve-related Serious Adverse Event (SAE) [ Time Frame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. ]
    Other site reported valve-related SAE such as, but not limited to, bleeding, thromboembolism, valve thrombosis, endocarditis, non structural dysfunction, structural valve deterioration annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients having received a Sorin Group aortic valve device in accordance with the IFU can be included in the registry. Other than the indication and the contra-indications specified in each IFU, there are no specific inclusion and exclusion criteria since this registry has the aim to include all patients following "real life"/standard of care practices at participating centers. All patients must provide written or oral informed consent to participate in the registry following the local regulations.
Criteria

Inclusion Criteria:

  • All patients must provide written or oral informed consent to participate in the registry depending on the local regulations.
  • Patients having received a Sorin Group aortic valve device in accordance with the IFU

Exclusion Criteria: NA


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679404


Contacts
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Contact: Gaia Giannicola +393451174649 gaia.giannicola@livanova.com
Contact: Rita Herrenknecht +4915254677298 rita.herrenknecht@livanova.com

  Show 52 Study Locations
Sponsors and Collaborators
LivaNova
Investigators
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Study Director: Ana Cebrian-Baux LivaNova

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Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT02679404     History of Changes
Other Study ID Numbers: APR001
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by LivaNova:
Biological aortic valves
Mechanical aortic valves
Aortic conduits
Sutureless Aortic Valve

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction