Clinical trial NCT02205359: AdaptResponse Clinical Trial
Official title: AdaptResponse Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure With Left Bundle Branch Block
Keywords: AdaptivCRT
aCRT
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2014-07-31
Enrollment: 3797
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).


Eligibility criteria: Inclusion Criteria:

* Subject is willing to sign and date the study Patient Informed Consent Form.
* Subject is indicated for a CRT device according to local guidelines.
* Sinus Rhythm at time of enrollment
* Complete Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Strauss Criteria used for LBBB.
* Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment).
* Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment).
* NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.

Exclusion Criteria:

* Subject is less than 18 years of age (or has not reached minimum age per local law).
* Subject is not expected to remain available for at least 2 years of follow-up visits.
* Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
* Subject is, or previously has been, receiving cardiac resynchronization therapy.
* Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
* Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment.
* Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study.
* Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded).
* Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study.
* Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant).
* Subject meets any exclusion criteria required by local law.

Primary outcomes:
measure: Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation
timeFrame: from subject randomization until the first occurrence of death or intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)
Secondary outcomes:
measure: All-cause Mortality
timeFrame: from subject randomization until the occurrence of death, median follow-up 4.9 years (max. follow-up 8.1 years)
measure: Percent of Patients With Interventions for Heart Failure Decompensation
timeFrame: from subject randomization until the first occurrence of intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)
measure: Clinical Composite Score
timeFrame: CCS at 6 month post randomization
measure: Atrial Fibrillation
timeFrame: from subject randomization until the first occurrence of atrial fibrillation lasting >6 hours in one day, median follow-up 4.9 years (max. follow-up 8.1 years)
measure: Change in Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: from baseline to 24M follow up
measure: Change in Quality of Life Measured by the EQ-5D
timeFrame: from baseline to 24M follow up
measure: All-cause Re-admissions Within 30 Days After a Heart Failure Admission Per 100 Patient Years
timeFrame: from subject randomization until study exit, median follow-up 4.9 years (max. follow-up 8.1 years)
Other outcomes:
Locations:
city: Mesa
country: United States
facility: CardioVascular Associates of Mesa
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group, LLC
state: Arizona
city: Little Rock
country: United States
facility: Saint Vincent Heart Clinic Arkansas
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Green Hospital Scripps Clinic Torrey Pines
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Jose
country: United States
facility: Coggins & Levy Medical Associates
state: California
city: Stanford
country: United States
facility: Stanford Hospital & Clinics
state: California
city: Stockton
country: United States
facility: Saint Joseph's Medical Center
state: California
city: Colorado Springs
country: United States
facility: Penrose Hospital
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Heart & Vascular Institute of Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: Florida Heart Rhythm Specialists PLLC
state: Florida
city: Gainesville
country: United States
facility: The Cardiac & Vascular Institute
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute PA
state: Florida
city: Miami
country: United States
facility: Cardiovascular Research Center of South Florida
state: Florida
city: Orlando
country: United States
facility: AdventHealth Cardiovascular Research Institute
state: Florida
city: Panama City
country: United States
facility: Cardiology Institute of Northwest Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida Health (USF)
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Chicago
country: United States
facility: Northwerstern University
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Indianapolis
country: United States
facility: Saint Francis Medical Group Indiana Heart Physician
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital (Boston MA)
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Heart and Vascular Institute
state: Minnesota
city: Saint Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Mid America Heart Institute (MAHI)
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute Cardiology
state: Montana
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Heart Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Utica
country: United States
facility: Central New York Cardiology
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associate PA
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center (DUMC)
state: North Carolina
city: High Point
country: United States
facility: Wake Forest Baptist Health High Point Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Cardiology Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel East
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Elyria
country: United States
facility: North Ohio Heart-Elyria
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital Research Foundation
state: Oklahoma
city: Eugene
country: United States
facility: Sacred Heart Medical Center
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Camp Hill
country: United States
facility: Capital Area Research
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Newtown
country: United States
facility: Mercer Bucks Cardiology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Presbyterian
state: Pennsylvania
city: Scranton
country: United States
facility: Great Valley Cardiology
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Memphis
country: United States
facility: Sutherland Cardiology Clinic
state: Tennessee
city: Nashville
country: United States
facility: Centennial Heart Cardiovascular Consultants LLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Dallas
country: United States
facility: The University of Texas (UT) Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: CHI St. Luke's Heath Baylor College of Medicine Medical Center
state: Texas
city: Plano
country: United States
facility: Baylor Research Institute
state: Texas
city: The Woodlands
country: United States
facility: EP Heart LLC
state: Texas
city: Tyler
country: United States
facility: Tyler Cardiovascular Consultants
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Burlington
country: United States
facility: The University of Vermont Medical Center Inc
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists PC
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center Cherry Hill
state: Washington
city: Spokane
country: United States
facility: Providence Spokane Cardiology
state: Washington
city: Charleston
country: United States
facility: CAMC Health Education & Research Institute Inc
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Sydney
country: Australia
facility: Saint Vincent's Hospital (Sydney)
city: Innsbruck
country: Austria
facility: Landeskrankenhaus Innsbruck - Universitätskliniken
city: Linz
country: Austria
facility: Allgemeines Krankenhaus der Stadt Linz
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende av
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg - Campus St.-Jan
city: London
country: Canada
facility: London Health Sciences Centre - University Campus
city: Montreal
country: Canada
facility: McGill Universtiy Health Centre (MUHC)
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
city: Vancouver
country: Canada
facility: Royal Columbian Hospital
city: Vancouver
country: Canada
facility: Vancouver General Hospital
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Jyväskylä
country: Finland
facility: Keski-Suomen Keskussairaala
city: Pori
country: Finland
facility: Satakunnan keskussairaala
city: Amiens
country: France
facility: Centre Hospitalier Universitaire de Amiens - Hôpital SU
city: Chambray lès tours
country: France
facility: CHRU Tours - Hôpital Trousseau
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: La Rochelle
country: France
facility: CHRU La Rochelle
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon
city: Lille
country: France
facility: CHRU de Lille
city: Lomme
country: France
facility: groupe Hospitalier de L'Institut Catholique de Lille - Hôpital Saint-Philibert
city: Marseille
country: France
facility: Hopital prive Clairval - Ramsay Sante
city: Marseille
country: France
facility: Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Metz
country: France
facility: CHR Metz-Thionville Hôpital de Mercy
city: Montpellier Cedex 5
country: France
facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Neuilly-sur-Seine
country: France
facility: CMC-Clinique Ambroise Pare
city: Rennes Cedex 9
country: France
facility: Hôpital Pontchaillou - CHU de Rennes
city: Toulouse Cedex 9
country: France
facility: CHU Toulouse - Hôpital Rangueil
city: Bernau bei Berlin
country: Germany
facility: Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg
city: Bochum
country: Germany
facility: Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
city: Chemnitz
country: Germany
facility: MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Dresden
country: Germany
facility: Praxisklinik Herz und Gefässe - Akademische Lehrpraxisklinik der TU Dresden
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Homburg/Saar
country: Germany
facility: Universitätskliniken des Saarlandes
city: Jena
country: Germany
facility: Universitätsklinikum Jena - Friedrich Schiller Universität
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck
city: Lüdenscheid
country: Germany
facility: Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid
city: Lüdenscheid
country: Germany
facility: Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
city: Magdeburg
country: Germany
facility: Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R.
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus
city: München
country: Germany
facility: Klinikum der Universität München - Campus Großhadern
city: Riesa
country: Germany
facility: Herz Riesa, Gemeinschaftspraxis
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Budapest
country: Hungary
facility: Magyar Honvédség Honvédkorház
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK
city: Gurgaon
country: India
facility: Medanta - The Medicity
city: New Delhi
country: India
facility: Fortis Escorts Heart Institute
city: Bologna
country: Italy
facility: Policlinico Sant' Orsola - Malpighi
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Chioggia
country: Italy
facility: Ospedale Civile Madonna Della Navicella
city: Mantova
country: Italy
facility: Azienda Ospedaliera Carlo Poma
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
state: Aomori Prefecture
city: Chiba-Shi
country: Japan
facility: Chiba University Hospital
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
city: Mitaka-Shi
country: Japan
facility: Kyorin University Hospital
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Okayama-Shi
country: Japan
facility: Sakakibara Heart Institute of Okayama
city: Shimonoseki-Shi
country: Japan
facility: Saitama Medical Center Jichi Medical University
city: Suita-Shi
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Tsukuba
country: Japan
facility: University of Fukui Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Gyeonggi-Do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Leon
country: Mexico
facility: Hospital Angeles Leon
state: Guanajuato
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis - Locatie Molengracht Breda
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Zwolle
country: Netherlands
facility: Isala Klinieken - Locatie Weezenlanden
city: Bergen
country: Norway
facility: Helse Bergen HF - Haukeland Universitetssjukehus
city: Kalisz
country: Poland
facility: Wojewódzki Szpital Zespolony im. Ludwika Perzyny w Kaliszu
city: Katowice
country: Poland
facility: Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
city: Kielce
country: Poland
facility: Regional Hospital Szpital Wojewodski
city: Lublin
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
city: Rzeszów
country: Poland
facility: Spital Wojewodzki nr 2
city: Zabrze
country: Poland
facility: Slaskie Centrum Chorob Serca
city: Beja
country: Portugal
facility: Unidade Local de Saude do Baixo Alentejo, EPE - Hospital José Joaquim Fernandes
city: Coimbra
country: Portugal
facility: Centro Hospitalar de Coimbra
city: Évora
country: Portugal
facility: Hospital de Espírito Santo E.P.E.
city: Coto Laurel
country: Puerto Rico
facility: The Arrhythmia Group
city: San Juan
country: Puerto Rico
facility: Cardiovascular Center
city: Moscow
country: Russian Federation
facility: AV Vishnevsky Institute of Surgery of the Ministry of Health of the Russian Federation
city: Novosibirsk
country: Russian Federation
facility: EN Meshalkin National medical research center of the Ministry of Health of the Russian Federation
city: St Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
city: Jeddah
country: Saudi Arabia
facility: King Abdul Aziz University Hospital
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces Hospital
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Riyadh
country: Saudi Arabia
facility: The College of Medicine & King Khalid University Hospital, King Saud University
city: Banska Bystrica
country: Slovakia
facility: Stredoslovensky ustav srdcovych a cievnych chorob a.s
city: Bratislava 37
country: Slovakia
facility: NUSCH, a.s.
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Burgos
country: Spain
facility: Nuevo Hospital de Burgos
city: El Palmar
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Málaga
country: Spain
facility: Hospital Clínico Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Vigo
country: Spain
facility: Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Fribourg
country: Switzerland
facility: HFR Fribourg - Hôpital cantonal
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin Chu Branch
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital - NHS Trust
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Foundation Trust - Royal Brompton Hospital
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust - Wythenshawe Hospital
Study officials:
affiliation: The Cleveland Clinic
name: Bruce Wilkoff, MD
role: STUDY_CHAIR
References:
citation: Wilkoff BL, Birnie D, Gold MR, Hersi AS, Jacobs S, Gerritse B, Kusano K, Leclercq C, Mullens W, Filippatos G. Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy. ESC Heart Fail. 2020 Oct;7(5):2972-2982. doi: 10.1002/ehf2.12914. Epub 2020 Aug 13.
citation: Filippatos G, Birnie D, Gold MR, Gerritse B, Hersi A, Jacobs S, Kusano K, Leclercq C, Mullens W, Wilkoff BL; AdaptResponse Investigators. Rationale and design of the AdaptResponse trial: a prospective randomized study of cardiac resynchronization therapy with preferential adaptive left ventricular-only pacing. Eur J Heart Fail. 2017 Jul;19(7):950-957. doi: 10.1002/ejhf.895.