MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing (MORE CRT MPP)

April 21, 2023 updated by: Abbott Medical Devices

MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)

The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a prospective, randomized, multi-center trial. Data will be collected at enrollment, baseline, implant procedure, patient classification, 6 months and 12 months of follow-up. During the 6-month visit, the patient's response to CRT will be evaluated according to LVESV reduction. Patients with an LVESV reduction of at least 15% will be classified as responders. These patients will terminate their participation in the study and return to the center's standard practice. Patients with an LVESV reduction less than 15% will be classified as non-responders and the MPP feature will be activated according to randomization result and they will be followed until the 12-month visit.

Study Type

Interventional

Enrollment (Actual)

5850

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Australia
      • Adelaide, Australia
        • Royal Adelaide Hospital
      • Bedford Park, Australia, 5042
        • Flinders Medical Centre
      • Brisbane, Australia
        • St. Andrews War Memorial Hospital
      • Melbourne, Australia
        • The Alfred Hospital
      • Westmead, Australia
        • Westmead Hospital
  • Austria
      • St. Poelten, Austria
        • Krankenhaus der Stadt St. Poelten
      • Vienna, Austria, 1130
        • Krankenhaus Hietzing
      • Vienna, Austria
        • Wilhelminenspital
  • Belgium
      • Brussels, Belgium
        • Hôpital Erasme
      • Gilly, Belgium
        • St. Joseph Gilly
  • Canada
      • Calgary, Canada
        • Foothills Medical Centre
      • Edmonton, Canada
        • Royal Alexandra Hospital
      • Halifax, Canada
        • QEII Health Sciences
      • Kingston, Canada
        • Kingston General Hospital
      • Montreal, Canada
        • Institut de Cardiologie de Montréal
      • Montréal, Canada
        • Hôtel Dieu de CHUM
      • Montréal, Canada
        • McGill University Health Centre General Hospital
      • Sainte-Foy, Canada
        • Institut de Cardiologie de Quebec
      • Sherbrooke, Canada, J1H 5N4
        • CHUS Fleurimont
      • St. Johns, Canada
        • HSC, Eastern Health
      • Toronto, Canada
        • Rouge Valley Centenary
      • Vancouver, Canada
        • St. Paul's Hospital
  • China
      • Hong Kong, China
        • Prince of Wales Hospital
  • Colombia
      • Cali, Colombia
        • Angiografia Clinica de Occidente
      • Medellín, Colombia
        • Clinica Cardio VID
  • Denmark
      • Aarhus, Denmark
        • Skejby University Hospital
    • Fyn
      • Odense, Fyn, Denmark, 5000
        • Odense University Hospital
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, DK-9000
        • Aalborg Sygehus Syd
  • Finland
      • Jyvaskyla, Finland
        • Keski-Suomi Central Hospital
      • Turku, Finland
        • Turku University Hospital
  • France
      • Brest, France
        • CHU Cavale Blanche
      • Chambray-lès-Tours, France
        • CHU Trousseau
      • Dijon, France
        • CHU François Mitterrand Dijon Bourgogne
      • Grenoble, France
        • CHRU Albert Michallon
      • Lille, France
        • CHRU Lille
      • Lomme, France
        • Hôpital Saint Philibert
      • Marseille, France
        • Hopital Saint Joseph
      • Montbéliard, France
        • Centre Hospitalier de Belfort-Montbéliard
      • Montpellier, France
        • CHU Montpellier
      • Nancy, France
        • CHU de Nancy - Hopital de Brabois
      • Nantes, France
        • Nouvelles Cliniques Nantaises
      • Nantes, France, 44093
        • CHU Hopital G. & R. Laënnec
      • Paris, France
        • Hôpital Pitié Salpetrière
      • Paris, France
        • Centre Cardiologique du Nord
      • Paris, France
        • Institute Cardio. Paris-Sud - Institut Jacques Cartier
      • Rennes, France, 35033
        • CHRU Hopital de Pontchaillou
      • Rouen, France
        • CHRU Rouen Hospital Charles Nicolle
      • Saint-Denis Cedex, France, 97405
        • CHR de La Reunion - Site du CHFG
      • Valence, France
        • Centre Hospitalier de Valence
      • Villeurbanne, France
        • Clinique du Tonkin
    • Alpes
      • Marseille, Alpes, France, 13009
        • Hopital CLAIRVAL
  • Germany
      • Bad Oeynhausen, Germany
        • Herz-und Diabetes Zentrum NRW
      • Bad Rothenfelde, Germany
        • Schuchtermann-Schillersche Kliniken
      • Berlin, Germany
        • Charite Campus Virchow Klinikum
      • Berlin, Germany
        • Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
      • Bielefeld, Germany
        • Klinikum Bielefeld
      • Bochum, Germany
        • Berufsgenossenschaftliche Kliniken Bergmannsheil
      • Coburg, Germany
        • Klinikum Coburg
      • Erfurt, Germany
        • Helios-Klinikum Erfurt GmbH
      • Erlangen, Germany
        • Kliniken der Friedrich-Alexander-Universitat
      • Essen, Germany
        • Elisabeth-Krankenhaus Essen GmbH
      • Greifswald, Germany
        • Universitätsklinikum Greifswald
      • Göttingen, Germany
        • Universitätsmedizin Göttingen Georg-August-Universität
      • Gütersloh, Germany
        • Klinikum Gütersloh gGmbH
      • Hamburg, Germany, 22457
        • Albertinen-Krankenhaus Hamburg
      • Ingolstadt, Germany
        • Klinikum Ingolstadt
      • Köln, Germany
        • St. Vinzenz-Hospital
      • Leipzig, Germany
        • Universitatsklinikum Leipzig
      • Leipzig, Germany
        • Klinikum St. Georg gGmbH
      • Ludenscheid, Germany
        • Klinikum Lüdenscheid
      • Lünen, Germany
        • St.-Marien-Hospital GmbH
      • Muenster, Germany
        • Universitatsklinikum Muenster
      • München, Germany
        • Deutsches Herzzentrum München des Freistaates Bayern
      • Oldenburg, Germany
        • Klinikum Oldenburg
      • Trier, Germany
        • Krankenhaus der Barmherzigen Brüder
      • Villingen-Schwenningen, Germany
        • Kliniken Villingen-Schwenningen
      • Würzburg, Germany
        • Universitatsklinikum Wurzburg
    • Baden-Wurttemberg
      • Singen, Baden-Wurttemberg, Germany, 78224
        • Hegau-Bodensee-Hochrhein-Kliniken GmbH
    • Baden-Württemberg
      • Bad Krozingen, Baden-Württemberg, Germany, 79189
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
        • Kerckhoff-Klinik gGmbH
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37073
        • Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50931
        • Medizinische Einrichtungen der Universität zu Köln
      • Köln, Nordrhein-Westfalen, Germany, 51103
        • Evangelisches Krankenhaus Kalk gGmbH
  • Greece
      • Athens, Greece, 17674
        • The Onassis Cardiac Center
  • India
      • Ahmedabad, India
        • Care Institute of Medical Sciences
      • Chandigarh, India
        • Postgraduate Institute of Medical Education & Research
      • Chennai, India
        • Apollo Hospital
      • Hyderabad, India
        • CARE Banjara
      • New Delhi, India
        • Escorts Heart Institute and Research Centre
      • New Delhi, India, 110017
        • Medanta Medicity Hospital
    • Haryana
      • Gurgaon, Haryana, India, 122 001
        • Medanta - The Medicity Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560076
        • Fortis Hospital
  • Israel
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center
      • Ramat Gan, Israel
        • Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Medical Center
  • Italy
      • Bari, Italy
        • Az.Osp.Universitaria Consorziale Policlinico
      • Bari, Italy
        • Azienda Ospedaliera Di Venere
      • Bologna, Italy
        • Policlinico S.Orsola Malpighi
      • Brescia, Italy
        • Az. Osp. Spedali Civili di Brescia
      • Caserta, Italy
        • Azienda Ospedaliera S. Anna e S Sebastiano
      • Lecce, Italy
        • Presidio Osp. Vito Fazzi
      • Naples, Italy
        • Clinica Mediterranea
      • Naples, Italy
        • Ospedale dei Pellegrini
      • Naples, Italy
        • Ospedale S. Giovanni Bosco
      • Novara, Italy
        • Az Osp.Universitaria Maggiore della Carità
      • Padova, Italy, 35128
        • Universita Degli Studi Di Padova
      • Peschiera del Garda, Italy
        • Casa di Cura Dott. Pederzoli
      • Pisa, Italy
        • Az. Osp. Universitaria Pisana-Presidio Santa Chiara
      • Portogruaro, Italy
        • Ospedale di Portogruaro
      • Ragusa, Italy
        • Azienda Ospedaliera "Civile - Maria Paternò Arezzo"
      • Roma, Italy
        • Policlinico Casilino
      • Roma, Italy, 00177
        • Ospedale Madre G. Vannini
      • Rome, Italy
        • Ospedale S. Giovanni Calibita Fatebenefratelli di Roma
      • San Fermo della Battaglia, Italy, 1 22020
        • Azienda Ospedaliera S. Anna
      • San Giovanni Rotondo, Italy, 71013
        • Casa Sollievo della Sofferenza
      • Verona, Italy
        • Ospedale Civile Maggiore di Verona Borgo Trento
  • Korea, Republic of
      • Bucheon-si, Korea, Republic of
        • Sejong General Hospital
      • Seongnam-si, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Yonsei University Health System
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 135-710
        • Samsung Medical Center
    • Seocho-gu
      • Seoul, Seocho-gu, Korea, Republic of, 137-701
        • Seoul St. Mary's Hospital
  • Lebanon
      • Beirut, Lebanon
        • American University of Beirut Medical Center
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Institut Jantung Negara
  • Malta
      • Paola, Malta
        • Mater Dei Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam Academic Medical Center (AMC)
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Zwolle, Netherlands
        • Isala Ziekenhuis
    • Noord-Brabant
      • Tilburg, Noord-Brabant, Netherlands, 5042 AD
        • Twee Steden Ziekenhuis
  • Poland
      • Lodz, Poland
        • Wojewodzki Specjalistyczny Szpital im. Bieganskiego
    • Slask
      • Zabrze, Slask, Poland, 41-800
        • Slaskie Centrum Chorob Serca
    • Slaskie
      • Katowice, Slaskie, Poland, 40-635
        • Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-848
        • Szpital Kliniczny Premienienia Panskiego
  • Portugal
      • Braga, Portugal
        • Hospital de Braga
      • Creixomil, Portugal, 4835-044
        • Centro Hospitalar do Alto Ave, Unidade de Guimarães
      • Lisboa, Portugal
        • Hospital Garcia de Orta, EPE
      • Lisbon, Portugal
        • Hospital de Santa Cruz
      • Lisbon, Portugal
        • Santa Maria Hospital
      • Vila Nova de Gaia, Portugal, 4434 502
        • Centro Hospitalar Vila Nova Gaia
  • Puerto Rico
      • Ponce, Puerto Rico
        • Arrhythmia Group
      • San Juan, Puerto Rico
        • Heart Rhythm Management
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21159
        • King Fahad Armed Forces Hospital
      • Riyadh, Saudi Arabia
        • King Fahad Medical City
  • Singapore
      • Singapore, Singapore
        • National University Hospital
  • Spain
      • A Coruña, Spain
        • Hospital Universitario A Coruña
      • Badajoz, Spain
        • Hospital Universitario Infanta Cristina
      • Barcelona, Spain
        • Hospital de La Santa Creu Y Sant Pau
      • Granada, Spain
        • Hospital Universitario Virgen de la Nieves
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28040
        • Fundación Jiménez Díaz
      • Madrid, Spain
        • Hospital Universitario Doce de Octubre
      • Madrid, Spain
        • Hospital Universitario Puerta de Hierro
      • Madrid, Spain, 15706
        • Complexo Hospitalario Universitario De Santiago
      • Malaga, Spain
        • HCU Virgen de la Victoria
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe
      • Vigo, Spain
        • Hospital Alvaro Cunqueiro
      • Zaragoza, Spain
        • Hospital Universitario Miguel Servet
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital Huddinge
  • Switzerland
      • Geneva, Switzerland
        • Hopital Cantonal Universitaire de Geneva
  • Taiwan
      • LinKou, Taiwan, 333
        • Chang Gung Memorial Hospital
    • Taipei
      • Taipei City, Taipei, Taiwan, 10002
        • National Taiwan University
  • United Kingdom
      • Ashington, United Kingdom
        • Wansbeck General Hospital
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Brighton, United Kingdom
        • The Royal Sussex Country Hospital
      • Glasgow, United Kingdom
        • Golden Jubilee National Hospital
      • London, United Kingdom
        • Kings College Hospital
      • London, United Kingdom
        • St. Thomas Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester Heart Center, Manchester Royal Infirmary
      • Oxford, United Kingdom
        • John Radcliffe Hospital
      • Southampton, United Kingdom
        • Southampton General Hospital
      • Swindon, United Kingdom
        • The Great Western Hospital
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC.
    • Arizona
      • Mesa, Arizona, United States, 85206
        • CardioVascular Associates of Mesa
      • Phoenix, Arizona, United States, 85018
        • Phoenix Cardiovascular Research Group
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Cardiovascular
      • Glendale, California, United States, 91206
        • Glendale Adventist Medical Center
      • La Jolla, California, United States, 92037
        • Scripps Health
      • Rancho Mirage, California, United States, 92270
        • Eisenhower Medical Center
      • Reseda, California, United States, 91335
        • Cardiac Rhythm Specialists, Inc.
      • San Diego, California, United States, 92123
        • San Diego Cardiac Center
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Colorado Heart & Vascular, P.C.
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Georgia
      • Macon, Georgia, United States, 31217
        • Coliseum Medical Centers
      • Rome, Georgia, United States, 30165
        • Redmond Regional Medical Center
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • St. Elizabeth Medical Center - South Unit
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Auburn Hills, Michigan, United States, 48326
        • McLaren Health Care Corporation
      • Midland, Michigan, United States, 48670
        • MidMichigan Medical Center-Midland
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • CHI Health Creighton University Medical Center-Bergan Mercy
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • Haddon Heights, New Jersey, United States, 08035
        • Cardiology Associates of Fairfield County, PC
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Samaritan Heart & Vascular Institute - Cardiology Dept.
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
        • Lancaster General Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • St. Francis Hospital
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Medical Center
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital
    • Texas
      • Dallas, Texas, United States, 75390-9016
        • University Of Texas Southwestern Medical Center At Dallas
      • Fort Worth, Texas, United States, 76104
        • Baylor All Saints Medical Center at Fort Worth
      • Houston, Texas, United States, 77094
        • Memorial Katy Cardiology Associates
      • Lufkin, Texas, United States, 75904
        • Vivek Mangla, MD
      • The Woodlands, Texas, United States, 77384
        • EP Heart

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meets the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs)
  • Must be willing and able to comply with study requirements
  • Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form

Exclusion Criteria:

  • Already had a CRT device implanted
  • Myocardial Infarction, unstable angina within 40 days prior the enrollment
  • Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
  • Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
  • Primary valvular disease

  • Atrial Fibrillation:

    • Persistent AF at the time of enrollment
    • Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant
    • History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
  • Unable to comply with the follow up schedule
  • Less than 18 years of age
  • Pregnant or are planning to become pregnant during the duration of the investigation
  • Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
  • Undergone a cardiac transplantation
  • Life expectancy < 12 months
  • Currently participating in any other clinical investigation

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MPP ON
MPP ON: feature is enabled
Device: MPP

All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device.

The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").
No Intervention: MPP OFF
MPP OFF: feature not enabled

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Non-responder Patients Who Converted to Responders
Time Frame: Non-responder to responder conversion rate between randomization at 6 months and 12 months
The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.
Non-responder to responder conversion rate between randomization at 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase
Time Frame: Baseline vs 6 Months
Reduction of LVESV between baseline and 6 Months visit
Baseline vs 6 Months
Clinical Composite Score Evaluation
Time Frame: Baseline vs 12 Months

Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below,

  • Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation
  • Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation
  • Unchanged: the patient was neither improved nor worsened
Baseline vs 12 Months
Reverse Left Ventricular (LV) Remodeling
Time Frame: Baseline vs 12 Months
Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months
Baseline vs 12 Months
NYHA Class Changes
Time Frame: Baseline vs 12 Months
Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.
Baseline vs 12 Months
6MWT Changes
Time Frame: Baseline vs 12 Months
Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU
Baseline vs 12 Months
Patient's QoL Score Changes (MLWHF)
Time Frame: Baseline vs 12 Months
Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life).
Baseline vs 12 Months

Collaborators and Investigators

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

Sponsor

Abbott Medical Devices

Investigators

  • Study Chair: Christophe Leclercq, Centre Cardio-Pneumologique, CHU Pontchaillou

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

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

December 1, 2013

Primary Completion (Actual)

May 30, 2021

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

December 4, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-13-006-ID-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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