An observational study in Structural Valve Deterioration, Structural Valve Degeneration and Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, sponsored by Institut für Pharmakologie und Präventive Medizin. Recruiting at 62 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Institut für Pharmakologie und Präventive Medizin · Observational
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure.
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, 3 years and 5 years.
Between 1.4 and 2.8% of all patients undergoing transcatheter heart valve (THV) implantation require a second THV implanted into the previously implanted THV because of clinically significant aortic regurgitation [1-3]. 90% of THV-in-THV implants were considered successful although the mortality in the redo-TAVI group was higher at similar STS risks as in those with a successful first implant.
Redo-TAVI may also be a promising treatment strategy in degenerated THVs, but there is insufficient knowledge which strategy and valve design may result in the best outcomes [4]. Evidence so far reported is based on case reports and small case series, but not on a prospective, multicenter documentation.
Currently, \~ 5% of THV are implanted in degenerated surgical bioprosthetic valves. With the expanded use of THV for treatment of lower risk patients with severe aortic stenosis (sAS), it is estimated that the number of patients requiring re-treatment for THV failure is likely to rise within the next years.
119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's planned enrollment of 250 is above the median of 119 across 49 observational studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Institut für Pharmakologie und Präventive Medizin is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with an indication for a redo-TAVI procedure considered eligible by the Local Heart Team and the Case Review Board for a SAPIEN family valve implantation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Consecutive patients fulfilling the following criteria:
Exclusion Criteria:
Note: For all patients included a defined core data set will be collected prospectively. All patients being in accordance with above stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with severe aortic stenosis (sAS) treated with TAVI developing SVD and thus an indication for redo-TAVI procedure
Procedure: Elective redo transcatheter aortic valve implantation (redo-TAVI)
Elective redo-TAVI procedure with the intention to treat the patient with a SAPIEN family valve implantation (currently the only registered medical devices for redo-TAVI use)
Also known as: redo-TAVI, redo-TAVR, Valve-in-Valve (ViV), TAV-in-TAV, TAVR-in-TAVR, Revalve
Efficacy: VARC-3 defined device success at 30 days
Determine VARC-3 defined device success at 30 days * Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication * Intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation) (Different definitions, in addition to the predefined such as the consideration of higher gradients than 20 mmHg, will be explored) These events will be adjudicated. Number and percentage of subjects with device success at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
Time frame: 30 days
Technical success: Technical success (at exit from procedure room)
Technical success at exit from procedure room defined as: * Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device (excluding pacemaker) or to a major vascular or access-related, or cardiac structural complication Number and percentage of subjects with technical success at exit from procedure room, along with individual component of the success, will be presented.
Time frame: end of intervention
Safety: VARC-3 defined early safety at 30 days
Determine VARC-3 defined early safety at 30 days: * Freedom from all-cause mortality * Freedom from all Stroke * Freedom from all VARC type 2-4 bleeding * Freedom from all major vascular, access-related, or cardiac structural complication * Freedom from all acute kidney injury stage III/IV * Freedom from all moderate/severe aortic regurgitation * Freedom from all new permanent pacemaker implantations due to procedure-related conduction abnormalities * Freedom from all surgery/intervention related to the device These events will be adjudicated. Number and percentage of subjects with early safety at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
Time frame: 30 days
Procedural Outcomes (30 days)
Procedural outcomes at 30 days, defined as: * Clinical and anatomical predictors of technical success (type of SVD \[stenosis vs. regurgitation\], valve size, implant depth, redo-TAVI balloon dilation, CT and echo-derived variables, etc.) * Rate of central and paravalvular regurgitation * Valve performance, including residual mean gradient * Risk and predictors of coronary obstruction Number and percentage of subjects with above specified outcomes at 30 days , along with individual component of the success, will be presented.
Time frame: 30 days
Durability of the second aortic THV (30 days)
Determine the durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis at thirty days (when it becomes apparent, but no systematic screening) * Endocarditis Definition of transcatheter heart valve thrombosis Clinical sequelae of a thromboembolic event (e.g. stroke, TIA, retinal occlusion, other evidence of systemic thromboembolism) or worsening valve stenosis/ regurgitation (e.g. signs of heart failure, syncope) and * Haemodynamic valve deterioration Stage 2 or 3 or * Confirmatory imaging (CT evidence of HALT† or TEE findings) In the absence of clinical sequelae, both * Haemodynamic valve deterioration Stage 3 and * Confirmatory imaging (CT evidence of HALT or TEE findings) Number and percentage of subjects with above specified criteria at 3 months, along with individual component of the success, will be presented.
Time frame: 30 days
Durability of the second aortic THV (3 months)
Determine the durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis at three months (if data obtained, when it becomes apparent, but no systematic screening) * Clinical transcatheter heart valve thrombosis at three months (if data obtained) * Endocarditis For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. Number and percentage of subjects with above specified criteria at 3 months, along with individual component of the success, will be presented.
Time frame: 3 months
Durability of the second aortic THV (12 months)
Determine the durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis at twelve months (when it becomes apparent, but no systematic screening) * Clinical transcatheter heart valve thrombosis at twelve months * All-cause mortality, stroke, myocardial infarction, and cardiovascular hospitalization at twelve months * Stage II or III structural valve degeneration according to VARC 3 definitions at twelve months (stage I may be documented) * Endocarditis For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. Number and percentage of subjects with above specified criteria at 12 months , along with individual component of the success, will be presented.
Time frame: 12 months
Durability of the second aortic THV (3 years)
Determine the durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis at 3 years (when it becomes apparent, but no systematic screening) * Clinical transcatheter heart valve thrombosis at 3 years * All-cause mortality, stroke, myocardial infarction, and cardiovascular hospitalization at 3 years For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5.
Time frame: 3 years
Durability of the second aortic THV (5 years)
Determine the durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis at 5 years (when it becomes apparent, but no systematic screening) * Clinical transcatheter heart valve thrombosis at 5 years * All-cause mortality, stroke, myocardial infarction, and cardiovascular hospitalization at 5 years For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5.
Time frame: 5 years
Compliance with recommendation
It will be assessed and percentages determined whether participating centers follow the published recommendation (itemized, compliance being voluntary).
Time frame: 12 months
Impact of alterations to published recommendations
The impact of potential alterations to the protocol on the procedural outcomes will be elucidated and descriptively described.
Time frame: 12 months
Discretionary longer-term follow-up
Discretionary longer-term follow-up in terms of durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis * Clinically symptomatic transcatheter heart valve thrombosis * All-cause mortality, stroke, and cardiovascular hospitalization * Stage II or III structural valve degeneration according to VARC 3 definitions For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. Number and percentage of subjects with above specified criteria with up to 5 years follow-up, along with individual component of the success, will be presented.
Time frame: up to 5 years
Exploratory objectives
Further, not predefined research questions will be explored based on the dataset such as: * Hemodynamic outcome of the intervention * Applicability of VARC-3 criteria for the redo-TAVI situation * Coronary artery obstruction due to valve implantation * Coronary artery cannulation (in particular in case of risk plane above ostia) * Early and late THV failure predictors (after TAVI and redo-TAVI procedures) * CT findings related to THV failure (SVD)
Time frame: 12 months
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Plan to share: No — no individual participant data (IPD) will be shared
Started Sep 2023 (actual). Primary completion is estimated for Dec 2026, 39 months after the start.
Of 28 observational studies under Prosthesis Failure, half reached primary completion within 181 months of starting (the median), counting those still running; a quarter within 57 and three quarters within 184. This study's planned 39 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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