Clinical trial NCT05601453: The ReTAVI Prospective Observational Registry
Official title: Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Edwards Lifesciences
First posted: 2022-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Consecutive patients fulfilling the following criteria:

1. Consenting adult patient (≥18 years)
2. Procedural success of the first TAVI
3. TAVI device failure of the index THV, irrespective of SVD severity
4. Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV)
5. The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI
6. Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital)

Exclusion Criteria:

1. Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)
2. Life expectancy below 12 months
3. Patients with largely incomplete data with respect to the aims of the project
4. Pregnant women at the time of the redo-TAVI

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.

Primary outcomes:
measure: Efficacy: VARC-3 defined device success at 30 days
timeFrame: 30 days
measure: Technical success: Technical success (at exit from procedure room)
timeFrame: end of intervention
measure: Safety: VARC-3 defined early safety at 30 days
timeFrame: 30 days
measure: Procedural Outcomes (30 days)
timeFrame: 30 days
measure: Durability of the second aortic THV (30 days)
timeFrame: 30 days
measure: Durability of the second aortic THV (3 months)
timeFrame: 3 months
measure: Durability of the second aortic THV (12 months)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Compliance with recommendation
timeFrame: 12 months
measure: Impact of alterations to published recommendations
timeFrame: 12 months
measure: Discretionary longer-term follow-up
timeFrame: up to 5 years
measure: Exploratory objectives
timeFrame: 12 months
Locations:
city: Graz
country: Austria
facility: LKH-University Hospital and Medical University of Graz
city: Linz
country: Austria
facility: Kepler University Clinic Linz
city: St. Pölten
country: Austria
facility: University Hospital St. Pölten
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Montréal
country: Canada
facility: McGill University Health Centre
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie
city: Vancouver
country: Canada
facility: St. Paul's Hospital, Vancouver
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Hôpitaux Universitaires de Marseille Timone
city: Massy
country: France
facility: Jacques Cartier Private Hospital, Massy
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou
city: Paris
country: France
facility: Hôpital Bichat-Claude-Bernard
city: Rennes
country: France
facility: Centre hospitalier universitaire de Rennes
city: Roubaix
country: France
facility: Centre Hospitalier Universitaire de Rouen
city: Saint-Denis
country: France
facility: Clinique de la Porte de Paris (CCN)
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
city: Bad Krozingen
country: Germany
facility: University Heart Center Freiburg Bad Krozingen
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH, UKGM GmbH
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center North Rhine-Westphalia
city: Berlin
country: Germany
facility: German Heart Center of Charité Berlin
city: Bochum
country: Germany
facility: BG University Hospital Bergmannsheil gGmbH
city: Duesseldorf
country: Germany
facility: University Hospital of Duesseldorf
city: Essen
country: Germany
facility: Elisabeth Hospital, Essen
city: Munich
country: Germany
facility: German Heart Centre Munich
city: Stuttgart
country: Germany
facility: Robert-Bosch-Hospital, Stuttgart
city: Ulm
country: Germany
facility: University Hospital Ulm
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti Ancona, Umberto I, G. M. Lancisi, G. Salesi
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria di Bologna
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
city: Florence
country: Italy
facility: Careggi Hospital
city: Milan
country: Italy
facility: IRCCS Ospedale Galeazzi Sant'Ambrogio
city: Padua
country: Italy
facility: Azienda Ospedale-Università Padova (AOUP)
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Roma
country: Italy
facility: Policlinici universitari | Sapienza Università di Roma
city: Trieste
country: Italy
facility: Università degli Studi di Trieste
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis, Nieuwegein
city: Bialystok
country: Poland
facility: Medical University of Bialystok
city: Gdańsk
country: Poland
facility: University Clinical Centre of Gdańsk
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Kraków
country: Poland
facility: University Hospital of Kraków
city: Warsaw
country: Poland
facility: Medical University of Warsaw
city: Warsaw
country: Poland
facility: Institute of Cardiology Warsaw
city: Wrocław
country: Poland
facility: Wroclaw Medical University
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz, Carnaxide-Lisabon
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia / Espinho
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital University Germans Trias i Pujol
city: León
country: Spain
facility: Hospital Universitario de León
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro, Vigo
city: Basel
country: Switzerland
facility: University Hospital of Basel
city: Geneva
country: Switzerland
facility: Hôpitaux universitaires de Genève
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois et Université de Lausanne
Study officials:
affiliation: University of Padua Medical School, Padua, Italy
name: Giuseppe Tarantini, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Silesia, Katowice, Poland
name: Radoslaw Parma, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Timone, Marseille, France
name: Thomas Cuisset, Prof.
role: STUDY_CHAIR
affiliation: University Hospital Germans Trias i Pujol, Badalona, Spain
name: Victoria Delgado, Prof.
role: STUDY_CHAIR
affiliation: German Heart Center, Technical University of Munich, Munich, Germany
name: Michael Joner, Prof.
role: STUDY_CHAIR
affiliation: Hopital Haut Levêque - Centre Hospitalier Universitaire de Bordeaux, France
name: Thomas Modine, Prof.
role: STUDY_CHAIR
affiliation: nstitut Universitaire de Cardiologie et de Pneumologie de Québec, Canada
name: Josep Rodés-Cabau, Prof.
role: STUDY_CHAIR
affiliation: University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy
name: Francesco Saia, Prof.
role: STUDY_CHAIR
affiliation: Department of Cardiology, Munich Heart Center, Technical University of Munich, Germany
name: Hector A. Alvarez Covarrubias, MD
role: STUDY_CHAIR
affiliation: Department Interventional Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Coppenhagen, Denmark
name: Ginatutas Bieliauskas, MD
role: STUDY_CHAIR
affiliation: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy
name: Luca Nai Fovino, MD
role: STUDY_CHAIR
affiliation: Interventional Cardiology, Centre Hospitalier Universitaire de Lille, France
name: Eric Van Belle, MD
role: STUDY_CHAIR
affiliation: Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland
name: Rafał Wolny, MD
role: STUDY_CHAIR
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citation: VARC-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.
citation: Tarantini 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.
citation: Leon 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.
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citation: Toggweiler 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.
citation: Kamioka 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.
citation: Webb 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.
citation: Deeb 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.
citation: Kopp-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.