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The Prospective Segeberg TAVI Registry (POST-TAVI)

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ClinicalTrials.gov Identifier: NCT03192774
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Segeberger Kliniken GmbH

Brief Summary:
A single center registry including all patients treated with TAVI at the Heart Center, Bad Segeberg, Germany

Condition or disease Intervention/treatment
Aortic Valve Stenosis Device: Transcatheter Aortic Valve Implantation

Detailed Description:
A prospective single center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan beyond 5 years to assess valve durability.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Prospective Follow-up Assessment of Transcatheter Aortic Valve Implantation in Bad Segeberg
Actual Study Start Date : September 2007
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2032

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Transcatheter Aortic Valve Implantation
    Interventional replacement of the aortic valve


Primary Outcome Measures :
  1. Mortality [ Time Frame: Up to 10 years ]
    Cardiovascular and not cardiovascular death


Secondary Outcome Measures :
  1. Structural valve deterioration [ Time Frame: Up to 10 years ]
    Transprosthetic mean pressure gradient ≥40 mmHg and/or ≥20 mmHg rise from baseline OR severe intraprosthetic aortic regurgitation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All comers patient population treated with TAVI.
Criteria

Inclusion Criteria:

  • All patients treated with TAVI

Exclusion Criteria:

  • None

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): NCT03192774


Contacts
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Contact: Mohamed Abdel-Wahab, MD mohamed.abdel-wahab@segebergerkliniken.de
Contact: Ralph Toelg ralph.toelg@segebergerkliniken.de

Locations
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Germany
Heart Center, Segeberger Kliniken Recruiting
Bad Segeberg, Germany, 23795
Contact: Mohamed Abdel-Wahab, MD         
Sponsors and Collaborators
Segeberger Kliniken GmbH
Investigators
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Study Chair: Gert Richardt, MD Heart Center, Segeberger Kliniken
Principal Investigator: Mohamed Abdel-Wahab, MD Heart Center, Segeberger Kliniken

Additional Information:

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Responsible Party: Segeberger Kliniken GmbH
ClinicalTrials.gov Identifier: NCT03192774     History of Changes
Other Study ID Numbers: SK 109 -- 168/11
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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