The Prospective Segeberg TAVI Registry


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This study is currently recruiting participants.

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Verified June 2017 by Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

Sponsor:

Information provided by (Responsible Party):

Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

ClinicalTrials.gov Identifier:

NCT03192774

First received: June 18, 2017

Last updated: June 18, 2017

Last verified: June 2017

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

Aortic Valve Stenosis Device: Transcatheter Aortic Valve Implantation

Study Type: Observational [Patient Registry]
Study Design: 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

Primary Outcome Measures:

  • Mortality [ Time Frame: Up to 10 years ]

Secondary Outcome Measures:

  • Structural valve deterioration [ Time Frame: Up to 10 years ]

Estimated Enrollment: 2000
Actual Study Start Date: September 2007
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Intervention Details:

Device: Transcatheter Aortic Valve Implantation

Interventional replacement of the aortic valve

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.

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample

All comers patient population treated with TAVI.

Inclusion Criteria:

  • All patients treated with TAVI

Exclusion Criteria:

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: NCT03192774

Heart Center, Segeberger Kliniken
Bad Segeberg, Germany, 23795
Contact: Mohamed Abdel-Wahab, MD         

Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

Study Chair: Gert Richardt, MD Heart Center, Segeberger Kliniken
Principal Investigator: Mohamed Abdel-Wahab, MD Heart Center, Segeberger Kliniken

Responsible Party: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
ClinicalTrials.gov Identifier: NCT03192774     History of Changes
Other Study ID Numbers: 168/11
Study First Received: June 18, 2017
Last Updated: June 18, 2017
Individual Participant Data  
Plan to Share IPD: No

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:

Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on June 20, 2017