The ReTAVI Prospective Observational Registry

August 14, 2025 updated by: Institut für Pharmakologie und Präventive Medizin

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Recruiting
        • LKH-University Hospital and Medical University of Graz
        • Contact:
          • Gabor Tóth-Gayor, Prof.
      • Linz, Austria, 4020
        • Recruiting
        • Kepler University Clinic Linz
        • Contact:
          • Andreas F. Zierer, Prof.
      • St. Pölten, Austria, 3100
        • Recruiting
        • University Hospital St. Pölten
        • Contact:
          • Julia Mascherbauer, Prof.
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
          • Christian Hengstenberg, Prof.
  • Canada
      • Montréal, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
        • Contact:
          • • Prof. Nicolo Piazza, Prof.
      • Québec, Canada, QC G1V 4G5
        • Recruiting
        • Institut Universitaire de Cardiologie et de Pneumologie
        • Contact:
          • Josep Rodés-Cabau, Prof.
      • Vancouver, Canada, BC V6Z 1Y6
        • Recruiting
        • St. Paul's Hospital, Vancouver
        • Contact:
          • John Webb, Prof.
  • France
      • Bordeaux, France, 33604
        • Recruiting
        • Centre Hospitalier Universitaire De Bordeaux
        • Contact:
          • Lionel Leroux
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Centre Hospitalier Universitaire de Clermont-Ferrand
        • Contact:
          • Nicolas Combaret, Dr.
      • Lille, France, 59037
        • Recruiting
        • Centre Hospitalier Universitaire de Lille
        • Contact:
          • Arnaud Sudre, Prof.
      • Lyon, France, 69677
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
          • Gilles Rioufol, Prof.
      • Marseille, France, 13005
        • Recruiting
        • Hôpitaux Universitaires de Marseille Timone
        • Contact:
          • Thomas Cuisset, Prof.
      • Massy, France, 91300
        • Recruiting
        • Jacques Cartier Private Hospital, Massy
        • Contact:
          • Philippe Garot, Prof.
      • Nantes, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes
        • Contact:
          • Vincent Letocart, Dr.
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges-Pompidou
        • Contact:
          • Nicole Karam, Prof.
      • Paris, France, 75018
        • Recruiting
        • Hôpital Bichat-Claude-Bernard
        • Contact:
          • Marina Urina, Prof.
      • Rennes, France, 35033
        • Recruiting
        • Centre Hospitalier Universitaire de Rennes
        • Contact:
          • Vincent Auffret, Dr.
      • Roubaix, France, 76000
        • Recruiting
        • Centre Hospitalier Universitaire de Rouen
        • Contact:
          • Eric Durand, Prof.
      • Saint-Denis, France, 93200
        • Recruiting
        • Clinique de la Porte de Paris (CCN)
        • Contact:
          • Mohamed Nejjary, Dr.
      • Toulouse, France, 31059
        • Recruiting
        • Centre Hospitalier Universitaire de Toulouse
        • Contact:
          • Thibault Lhermusier, Dr.
  • Germany
      • Bad Krozingen, Germany, 79189
        • Recruiting
        • University Heart Center Freiburg Bad Krozingen
        • Contact:
          • Tau Hartikainen, Dr.
      • Bad Nauheim, Germany, 61231
        • Recruiting
        • Kerckhoff-Klinik GmbH, UKGM GmbH
        • Principal Investigator:
          • Birgid Gonska, MD
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • Heart and Diabetes Center North Rhine-Westphalia
        • Contact:
          • Sabine Bleiziffer, Prof.
      • Berlin, Germany, 13353
        • Recruiting
        • German Heart Center of Charité Berlin
        • Contact:
          • Henrik Dreger, Prof.
      • Bochum, Germany, 44789
        • Recruiting
        • BG University Hospital Bergmannsheil gGmbH
        • Contact:
          • Moritz Seiffert, Prof.
      • Duesseldorf, Germany, 40225
        • Recruiting
        • University Hospital of Duesseldorf
        • Contact:
          • Christian Jung, Prof.
      • Essen, Germany, 45138
        • Recruiting
        • Elisabeth Hospital, Essen
        • Contact:
          • Dinah Choudhury, Dr.
      • Munich, Germany, 80636
        • Recruiting
        • German Heart Centre Munich
        • Contact:
          • Tobias Rheude, Dr.
      • Stuttgart, Germany, 70376
        • Recruiting
        • Robert-Bosch-Hospital, Stuttgart
        • Contact:
          • Peter Ong, Prof.
      • Ulm, Germany, 89070
        • Recruiting
        • University Hospital Ulm
        • Contact:
          • Wolfgang Rottbauer, Prof.
  • Israel
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Medical Center
        • Contact:
          • Jeremy Ben-Shoshan, Dr.
  • Italy
      • Ancona, Italy, 60126
        • Withdrawn
        • AOU Ospedali Riuniti Ancona, Umberto I, G. M. Lancisi, G. Salesi
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero Universitaria di Bologna
        • Contact:
          • Francesco Saia, Prof.
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
        • Contact:
          • Marianna Adamo, Prof.
      • Florence, Italy, 50134
        • Recruiting
        • Careggi Hospital
        • Contact:
          • Francesco Meucci, Dr.
      • Milan, Italy, 20157
        • Recruiting
        • IRCCS Ospedale Galeazzi Sant'Ambrogio
        • Contact:
          • Alfonso Ielasi, Dr.
      • Padua, Italy, 35128
        • Recruiting
        • Azienda Ospedale-Università Padova (AOUP)
        • Contact:
          • Chiara Fraccaro, Dr.
      • Pisa, Italy, 56124
        • Recruiting
        • Azienda Ospedaliero-Universitaria Pisana
        • Contact:
          • Marco De Carlo, Prof.
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
          • Francesco Burzotta, Dr.
      • Roma, Italy, 00185
        • Recruiting
        • Policlinici universitari | Sapienza Università di Roma
        • Contact:
          • Massimo Mancone, Prof.
      • Trieste, Italy, 34149
        • Recruiting
        • Università degli Studi di Trieste
        • Contact:
          • Enrico Fabris, Dr.
      • Vicenza, Italy, 36100
        • Recruiting
        • Ospedale San Bortolo di Vicenza
        • Contact:
          • Giovanna Erente, Dr.
  • Netherlands
      • Nieuwegein, Netherlands, 3435
        • Recruiting
        • St. Antonius Ziekenhuis, Nieuwegein
        • Contact:
          • Martin J. Swaans, Dr.
  • Poland
      • Bialystok, Poland, 15-089
        • Recruiting
        • Medical University of Bialystok
        • Contact:
          • Maciej Kralisz, Dr.
      • Gdańsk, Poland, 80-952
        • Withdrawn
        • University Clinical Centre of Gdańsk
      • Katowice, Poland, 40-055
        • Withdrawn
        • Medical University of Silesia
      • Kraków, Poland, 31-501
        • Recruiting
        • University Hospital of Kraków
        • Contact:
          • Jacek Legutko, Prof.
      • Warsaw, Poland, 02-091
        • Recruiting
        • Medical University of Warsaw
        • Contact:
          • Zenon Huczek, Prof.
      • Warsaw, Poland, 04-628
        • Recruiting
        • Institute of Cardiology Warsaw
        • Contact:
          • Maciej Dąbrowski, Dr.
      • Wrocław, Poland, 50-368
        • Recruiting
        • Wroclaw Medical University
        • Contact:
          • Marcin Protasiewicz, Dr.
  • Portugal
      • Carnaxide, Portugal, 2790-134
        • Recruiting
        • Hospital de Santa Cruz, Carnaxide-Lisabon
        • Contact:
          • Rui Campante Teles, Dr.
      • Vila Nova De Gaia, Portugal, 4434-502
        • Recruiting
        • Centro Hospitalar Vila Nova de Gaia / Espinho
        • Contact:
          • José A. Rodrigues, Dr.
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
          • Ander Regueiro, Dr.
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de La Santa Creu i Sant Pau
        • Contact:
          • Lluis Asmarats Serra, Dr.
      • Barcelona, Spain, 08916
        • Recruiting
        • Hospital University Germans Trias i Pujol
        • Contact:
          • Victoria Vilalta del Olmo, Dr.
      • León, Spain, 24008
        • Recruiting
        • Hospital Universitario de Leon
        • Contact:
          • María López Benito, Dr.
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico Universitario San Carlos
        • Contact:
          • Luis Nombela-Franco, Dr.
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Raquel del Valle Fernández, Dr.
      • Vigo, Spain, 36312
        • Recruiting
        • Hospital Álvaro Cunqueiro, Vigo
        • Contact:
          • Victor Alfonso Jiménez Díaz, Dr.
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital of Basel
        • Contact:
          • Thomas Nestelberger, Dr.
      • Geneva, Switzerland, 1205
        • Recruiting
        • Hopitaux Universitaires de Geneve
        • Contact:
          • Sarah Mauler-Wittwer, MD
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Centre hospitalier universitaire vaudois et Université de Lausanne
        • Contact:
          • David Maier, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 111 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
redo-TAVI patients
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)
Other Names:
  • redo-TAVI
  • Valve-in-Valve (ViV)
  • redo-TAVR
  • TAV-in-TAV
  • TAVR-in-TAVR
  • Revalve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days
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.
end of intervention
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.
30 days
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.
30 days
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.
30 days
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.
3 months
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.
12 months
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.
3 years
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.
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of alterations to published recommendations
Time Frame: 12 months
The impact of potential alterations to the protocol on the procedural outcomes will be elucidated and descriptively described.
12 months
Discretionary longer-term follow-up
Time Frame: up to 5 years

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.
up to 5 years
Exploratory objectives
Time Frame: 12 months

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)
12 months
Compliance with recommendation
Time Frame: 12 months
It will be assessed and percentages determined whether participating centers follow the published recommendation (itemized, compliance being voluntary).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut für Pharmakologie und Präventive Medizin

Collaborators

Edwards Lifesciences

Investigators

  • Principal Investigator: Giuseppe Tarantini, Prof., University of Padua Medical School, Padua, Italy
  • Principal Investigator: Radoslaw Parma, Dr., Medical University of Silesia, Katowice, Poland
  • Study Chair: Thomas Cuisset, Prof., Centre Hospitalier Universitaire de Timone, Marseille, France
  • Study Chair: Victoria Delgado, Prof., University Hospital Germans Trias i Pujol, Badalona, Spain
  • Study Chair: Michael Joner, Prof., German Heart Center, Technical University of Munich, Munich, Germany
  • Study Chair: Francesco Saia, Prof., University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy
  • Study Chair: Thomas Modine, Prof., Hopital Haut Levêque - Centre Hospitalier Universitaire de Bordeaux, France
  • Study Chair: Josep Rodés-Cabau, Prof., nstitut Universitaire de Cardiologie et de Pneumologie de Québec, Canada
  • Study Chair: Hector A. Alvarez Covarrubias, MD, Department of Cardiology, Munich Heart Center, Technical University of Munich, Germany
  • Study Chair: Luca Nai Fovino, MD, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy
  • Study Chair: Eric Van Belle, MD, Interventional Cardiology, Centre Hospitalier Universitaire de Lille, France
  • Study Chair: Rafał Wolny, MD, Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland
  • Study Chair: Ginatutas Bieliauskas, MD, Department Interventional Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Coppenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

October 7, 2022

First Submitted That Met QC Criteria

October 28, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReTAVI Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no individual participant data (IPD) will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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