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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

Tracking Information
First Submitted Date June 18, 2017
First Posted Date June 20, 2017
Last Update Posted Date July 26, 2019
Actual Study Start Date September 2007
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2019)
Mortality [ Time Frame: Up to 10 years ]
Cardiovascular and not cardiovascular death
Original Primary Outcome Measures
 (submitted: June 18, 2017)
Mortality [ Time Frame: Up to 10 years ]
Change History Complete list of historical versions of study NCT03192774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 28, 2019)
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
Original Secondary Outcome Measures
 (submitted: June 18, 2017)
Structural valve deterioration [ Time Frame: Up to 10 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Prospective Segeberg TAVI Registry
Official Title A Prospective Follow-up Assessment of Transcatheter Aortic Valve Implantation in Bad Segeberg
Brief Summary A single center registry including all patients treated with TAVI at the Heart Center, Bad Segeberg, Germany
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All comers patient population treated with TAVI.
Condition Aortic Valve Stenosis
Intervention Device: Transcatheter Aortic Valve Implantation
Interventional replacement of the aortic valve
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 18, 2017)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2032
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients treated with TAVI

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Mohamed Abdel-Wahab, MD mohamed.abdel-wahab@segebergerkliniken.de
Contact: Ralph Toelg ralph.toelg@segebergerkliniken.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03192774
Other Study ID Numbers SK 109 -- 168/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Segeberger Kliniken GmbH
Study Sponsor Segeberger Kliniken GmbH
Collaborators Not Provided
Investigators
Study Chair: Gert Richardt, MD Heart Center, Segeberger Kliniken
Principal Investigator: Mohamed Abdel-Wahab, MD Heart Center, Segeberger Kliniken
PRS Account Segeberger Kliniken GmbH
Verification Date June 2019