The ReTAVI Prospective Observational Registry

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry

ClinicalTrials.gov ID

NCT05601453

Acronym / sponsor ID

ReTAVI Registry

Conditions

Structural Valve Deterioration, Structural Valve Degeneration, Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction, Prosthesis Failure

Keywords

Transcatheter Aortic Valve Implantation (TAVI), Structural Valve Deterioration, redo-TAVI, THV-in-THV, TAV-in-TAV, TAVR-in-TAVR, Redo-TAVR, Revalve

Study type

Observational

Recruitment status

Recruiting

Enrolment

250 participants (estimated)

Lead sponsor

Institut für Pharmakologie und Präventive MedizinResearch network

Collaborators

Edwards Lifesciences

Study start

5 Sep 2023 (actual)

Primary completion

Dec 2026 (estimated)

Study completion

Dec 2031 (estimated)

First posted

1 Nov 2022 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Case only

Time perspective

Prospective

Target follow-up

5 Years

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Efficacy: VARC-3 defined device success at 30 days

   Time frame: 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.

2. Technical success: Technical success (at exit from procedure room)

   Time frame: end of intervention

   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.

3. Safety: VARC-3 defined early safety at 30 days

   Time frame: 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.

4. Procedural Outcomes (30 days)

   Time frame: 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.

5. Durability of the second aortic THV (30 days)

   Time frame: 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.

6. Durability of the second aortic THV (3 months)

   Time frame: 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.

7. Durability of the second aortic THV (12 months)

   Time frame: 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.

8. Durability of the second aortic THV (3 years)

   Time frame: 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.

9. Durability of the second aortic THV (5 years)

   Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
• Background: PubMed 33871579VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.
• Background: PubMed 36710143Tarantini G, Delgado V, de Backer O, Sathananthan J, Treede H, Saia F, Blackman D, Parma R. Redo-Transcatheter Aortic Valve Implantation Using the SAPIEN 3/Ultra Transcatheter Heart Valves-Expert Consensus on Procedural Planning and Techniques. Am J Cardiol. 2023 Apr 1;192:228-244. doi: 10.1016/j.amjcard.2023.01.010. Epub 2023 Jan 27.
• Background: PubMed 20961243Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
• Background: PubMed 21639811Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
• Background: PubMed 22625197Toggweiler S, Wood DA, Rodes-Cabau J, Kapadia S, Willson AB, Ye J, Cheung A, Leipsic J, Binder RK, Gurvitch R, Freeman M, Thompson CR, Svensson LG, Dumont E, Tuzcu EM, Webb JG. Transcatheter valve-in-valve implantation for failed balloon-expandable transcatheter aortic valves. JACC Cardiovasc Interv. 2012 May;5(5):571-577. doi: 10.1016/j.jcin.2012.03.008.
• Background: PubMed 29359409Kamioka N, Caughron H, Corrigan F, Block P, Babaliaros V. Supra-annular valve strategy for an early degenerated transcatheter balloon-expandable heart valve. Catheter Cardiovasc Interv. 2018 Dec 1;92(7):1458-1460. doi: 10.1002/ccd.27506. Epub 2018 Jan 23.
• Background: PubMed 28473128Webb JG, Mack MJ, White JM, Dvir D, Blanke P, Herrmann HC, Leipsic J, Kodali SK, Makkar R, Miller DC, Pibarot P, Pichard A, Satler LF, Svensson L, Alu MC, Suri RM, Leon MB. Transcatheter Aortic Valve Implantation Within Degenerated Aortic Surgical Bioprostheses: PARTNER 2 Valve-in-Valve Registry. J Am Coll Cardiol. 2017 May 9;69(18):2253-2262. doi: 10.1016/j.jacc.2017.02.057.
• Background: PubMed 28521921Deeb GM, Chetcuti SJ, Reardon MJ, Patel HJ, Grossman PM, Schreiber T, Forrest JK, Bajwa TK, O'Hair DP, Petrossian G, Robinson N, Katz S, Hartman A, Dauerman HL, Schmoker J, Khabbaz K, Watson DR, Yakubov SJ, Oh JK, Li S, Kleiman NS, Adams DH, Popma JJ. 1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses. JACC Cardiovasc Interv. 2017 May 22;10(10):1034-1044. doi: 10.1016/j.jcin.2017.03.018.
• Background: PubMed 30175405Kopp-Schneider A, Wiesenfarth M, Witt R, Edelmann D, Witt O, Abel U. Monitoring futility and efficacy in phase II trials with Bayesian posterior distributions-A calibration approach. Biom J. 2019 May;61(3):488-502. doi: 10.1002/bimj.201700209. Epub 2018 Sep 2.
• Derived from this study: PubMed 42219979Tarantini G, Fovino LN, Alvarez Covarrubias HA, Wolny R, Fabris T, Skipirzepa JN, Eden M, Zamorano JL, Joner M, Cuisset T, Delgado V, Rodes-Cabau J, Saia F, Bieliauskas G, Van Belle E, Modine T, Rheude T, Garot P, Jung C, Rudolph TK, Leroux L, Rottbauer W, Nestelberger T, Lhermusier T, Nejjari M, Regueiro A, Meier D, Fraccaro C, Hartikainen T, Karam N, Swaans M, Rodrigues A, Dreger H, Hengstenberg C, Schmitz T, Mauler-Wittwer S, Piazza N, Combaret N, Letocart V, Auffret V, Durand E, Urena-Alcazar M, Del Valle-Fernandez R, Drago A, De Carlo M, Jimenez Diaz VA, Dabrowski M, Mascherbauer J, Sudre A, Ong P, Gonska B, Mancone M, Fabris E, Teles RC, Nombela-Franco L, Asmarats L, Vilalta V, Protasiewicz M, Webb JG, Toth-Gayor G, Zierer A, Rioufol G, Seiffert M, Adamo M, Meucci F, Ielasi A, Burzotta F, Lopez Benito M, Loewenstein I, Kralisz P, Legutko J, Huczek Z, Pavei A, Rakova R, Wesselink W, Zielinski M, Trushina N, Bramlage P, Parma R. Early outcomes of redo-TAVI with the SAPIEN 3 platform: the prospective, multicentre ReTAVI registry. EuroIntervention. 2026 Jun 1;22(11):e629-e641. doi: 10.4244/EIJ-D-25-01268.
• The ReTAVi Registry webpage provides you with general details about the trial and gives you an overview of participating trial sites.Link provided by the sponsor.
• Individual participant dataSharing planned: No. no individual participant data (IPD) will be shared

Related trials for Structural Valve Deterioration

• Not yet recruitingObservational study

  REVIVE-FR Registry

  Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction

• Recruiting

  Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

  Aortic Valve Stenosis, Structural Valve Deterioration

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

62 sites in 11 countries: see every site and its status.