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NCT05601453
The ReDo-TAVI Prospective Observational Registry
Conditions: Aortic Valve Stenosis, Structural Valve Deterioration, Structural Valve Degeneration
Sex: All
Ages: 18 Years – N/A
Enrollment: 150
Sponsor: Institut für Pharmakologie und Präventive Medizin
Summary
The evidence on redo-TAVI (where a transcatheter heart valve [THV] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations.Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year.
Eligibility Criteria
Inclusion Criteria:Consecutive patients fulfilling the following criteria:Consenting adult patient (≥18 years)Consecutive patients with procedural success of the first TAVI irrespective of SVD severityIntention to treat the patient with a SAPIEN family valve implantationThe local heart team and the case review board considers the patient suitable and indicated for elective redo-TAVIPatient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits takin place in hospital)Optional/Recommended: 3 and 6 Months follow-up: hospital visit or phone callExclusion Criteria:Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)Life expectancy below 12 monthsPatients with largely incomplete data with respect to the aims of the projectNote: Patients included based on the intention to receive a SAPIEN family valve but requiring a different valve (other than SAPIEN family) or undergoing surgery will only be documented at baseline.
Source: ClinicalTrials.gov (NCT05601453). StuddyBuddy aggregates publicly available trial information.