AzTrials
AzTrials

Heart Failure With Left Bundle Branch BlockNCT02205359

AdaptResponse Clinical Trial

A study testing aCRT ON and aCRT OFF in people with Heart Failure With Left Bundle Branch Block, run by Medtronic Cardiac Rhythm and Heart Failure at 220 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
aCRT ON and aCRT OFF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,797 participants
Where
220 sitesin 28 countries
Study dates
Aug 2014to 2 Nov 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

220 sites in 28 countries.

220 sites in 28 countries

United States90 sites

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106-4921

  • Lehigh Valley Hospital

    Allentown, Pennsylvania

  • University of Michigan

    Ann Arbor, Michigan, 48109-5853

  • Asheville Cardiology Associate PA

    Asheville, North Carolina

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308-2225

  • Piedmont Heart Institute

    Atlanta, Georgia

  • Texas Cardiac Arrhythmia Research

    Austin, Texas

  • MedStar Health Research Institute

    Baltimore, Maryland, 21237-3958

  • Massachusetts General Hospital (Boston MA)

    Boston, Massachusetts, 02114-2621

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06606-4284

  • New York Methodist Hospital

    Brooklyn, New York

  • The University of Vermont Medical Center Inc

    Burlington, Vermont

  • Capital Area Research

    Camp Hill, Pennsylvania

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina

  • CAMC Health Education & Research Institute Inc

    Charleston, West Virginia

  • University of Virginia Medical Center

    Charlottesville, Virginia

  • Northwerstern University

    Chicago, Illinois, 60611

  • Bethesda North Hospital

    Cincinnati, Ohio

  • The Lindner Research Center

    Cincinnati, Ohio

  • Heart & Vascular Institute of Florida

    Clearwater, Florida, 33756-3367

  • Cleveland Clinic

    Cleveland, Ohio

  • University Hospitals Case Medical Center

    Cleveland, Ohio

  • Penrose Hospital

    Colorado Springs, Colorado, 80907-6863

  • OhioHealth Research Institute

    Columbus, Ohio, 43214

  • Mount Carmel East

    Columbus, Ohio

  • The Ohio State University

    Columbus, Ohio

  • The University of Texas (UT) Southwestern Medical Center

    Dallas, Texas

  • Duke University Medical Center (DUMC)

    Durham, North Carolina, 27705

  • North Ohio Heart-Elyria

    Elyria, Ohio

  • Sacred Heart Medical Center

    Eugene, Oregon

  • Florida Heart Rhythm Specialists PLLC

    Fort Lauderdale, Florida, 33308

  • The Cardiac & Vascular Institute

    Gainesville, Florida

  • Wake Forest Baptist Health High Point Medical Center

    High Point, North Carolina

  • CHI St. Luke's Heath Baylor College of Medicine Medical Center

    Houston, Texas

  • Saint Francis Medical Group Indiana Heart Physician

    Indianapolis, Indiana, 46237-6345

  • First Coast Cardiovascular Institute PA

    Jacksonville, Florida, 32256-6954

  • Glacier View Research Institute Cardiology

    Kalispell, Montana, 59901

  • Mid America Heart Institute (MAHI)

    Kansas City, Missouri, 64132

  • Scripps Green Hospital Scripps Clinic Torrey Pines

    La Jolla, California, 92037-1027

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • Saint Vincent Heart Clinic Arkansas

    Little Rock, Arkansas, 72205-6202

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048-5913

  • Medical Center of the Rockies

    Loveland, Colorado, 80528

  • Sutherland Cardiology Clinic

    Memphis, Tennessee

  • CardioVascular Associates of Mesa

    Mesa, Arizona, 85206

  • Cardiovascular Research Center of South Florida

    Miami, Florida

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53211

  • Aurora Cardiovascular Services

    Milwaukee, Wisconsin, 53215

  • University of Minnesota Medical Center Fairview

    Minneapolis, Minnesota, 55455

  • Centennial Heart Cardiovascular Consultants LLC

    Nashville, Tennessee

  • Vanderbilt University Medical Center

    Nashville, Tennessee

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121-2429

  • Icahn School of Medicine at Mount Sinai

    New York, New York

  • NYU Langone Medical Center

    New York, New York

  • Weill Medical College of Cornell University

    New York, New York

  • Mercer Bucks Cardiology

    Newtown, Pennsylvania

  • Sentara Norfolk General Hospital

    Norfolk, Virginia

  • Oklahoma Heart Hospital Research Foundation

    Oklahoma City, Oklahoma

  • AdventHealth Cardiovascular Research Institute

    Orlando, Florida, 32803-1248

  • Cardiology Institute of Northwest Florida

    Panama City, Florida, 32401-3665

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania

  • University of Pennsylvania

    Philadelphia, Pennsylvania

  • Phoenix Cardiovascular Research Group, LLC

    Phoenix, Arizona, 85018-3956

  • University of Pittsburgh Medical Center UPMC Presbyterian

    Pittsburgh, Pennsylvania

  • Baylor Research Institute

    Plano, Texas, 75093

  • Hudson Valley Heart Center

    Poughkeepsie, New York

  • Raleigh Cardiology Associates

    Raleigh, North Carolina

  • Virginia Cardiovascular Specialists PC

    Richmond, Virginia

  • Virginia Commonwealth University Health System

    Richmond, Virginia

  • North Memorial Heart and Vascular Institute

    Robbinsdale, Minnesota, 55422-2926

  • United Heart and Vascular Clinic

    Saint Paul, Minnesota, 55102-2568

  • University of Utah

    Salt Lake City, Utah

  • Coggins & Levy Medical Associates

    San Jose, California, 95124

  • Great Valley Cardiology

    Scranton, Pennsylvania, 18510

  • Swedish Medical Center Cherry Hill

    Seattle, Washington

  • Providence Spokane Cardiology

    Spokane, Washington

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62769-0002

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010

  • Stanford Hospital & Clinics

    Stanford, California, 94305-2200

  • Saint Joseph's Medical Center

    Stockton, California, 95204

  • Stony Brook University Medical Center

    Stony Brook, New York

  • University of South Florida Health (USF)

    Tampa, Florida, 33606

  • EP Heart LLC

    The Woodlands, Texas

  • William Beaumont Hospital

    Troy, Michigan, 48098-6375

  • Tyler Cardiovascular Consultants

    Tyler, Texas

  • Central New York Cardiology

    Utica, New York

  • Lourdes Cardiology Services

    Voorhees Township, New Jersey, 08043-4322

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010-3017

  • Michigan Heart

    Ypsilanti, Michigan, 48197-8633

Other trials in United States

France17 sites

  • Centre Hospitalier Universitaire de Amiens - Hôpital SU

    Amiens

  • CHRU Tours - Hôpital Trousseau

    Chambray-lès-Tours

  • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

    Clermont-Ferrand

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes

  • CHRU La Rochelle

    La Rochelle, 17019

  • Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon

    La Tronche

  • CHRU de Lille

    Lille

  • groupe Hospitalier de L'Institut Catholique de Lille - Hôpital Saint-Philibert

    Lomme

  • Hopital prive Clairval - Ramsay Sante

    Marseille

  • Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille

    Marseille

  • Institut Hospitalier Jacques Cartier

    Massy

  • CHR Metz-Thionville Hôpital de Mercy

    Metz

  • CHRU de Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier

  • Nouvelles Cliniques Nantaises

    Nantes

  • CMC-Clinique Ambroise Pare

    Neuilly-sur-Seine

  • Hôpital Pontchaillou - CHU de Rennes

    Rennes

  • CHU Toulouse - Hôpital Rangueil

    Toulouse

Other trials in France

Germany17 sites

  • Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg

    Bernau bei Berlin

  • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

    Bochum

  • MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz

    Chemnitz

  • Klinikum Coburg GmbH

    Coburg

  • Praxisklinik Herz und Gefässe - Akademische Lehrpraxisklinik der TU Dresden

    Dresden

  • Universitätsklinikum Düsseldorf

    Düsseldorf

  • Universitätsklinikum Heidelberg

    Heidelberg

  • Universitätskliniken des Saarlandes

    Homburg/Saar

  • Universitätsklinikum Jena - Friedrich Schiller Universität

    Jena

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck

  • Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid

    Lüdenscheid, 58515

  • Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH

    Lüdenscheid

  • Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R.

    Magdeburg, 39120

  • Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus

    Mönchengladbach

  • Klinikum der Universität München - Campus Großhadern

    München

  • Herz Riesa, Gemeinschaftspraxis

    Riesa

  • Universitätsklinikum Ulm

    Ulm, 89801

Other trials in Germany

Japan10 sites

  • Chiba University Hospital

    Chiba

  • Hirosaki University Hospital

    Hirosaki, Aomori

  • Kokura Memorial Hospital

    Kitakyushu

  • Kyorin University Hospital

    Mitaka-Shi

  • Nagoya University Hospital

    Nagoya

  • Sakakibara Heart Institute of Okayama

    Okayama

  • Saitama Medical Center Jichi Medical University

    Shimonoseki-Shi

  • National Cerebral and Cardiovascular Center

    Suita-Shi

  • Fujita Health University Hospital

    Toyoake

  • University of Fukui Hospital

    Tsukuba

Other trials in Japan

Spain10 sites

  • Hospital Universitario Infanta Cristina

    Badajoz

  • Nuevo Hospital de Burgos

    Burgos

  • Hospital Virgen de la Arrixaca

    El Palmar

  • Hospital Universitario Virgen de las Nieves

    Granada

  • Hospital Clínico Virgen de la Victoria

    Málaga

  • Hospital Clinico Universitario de Salamanca

    Salamanca

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife

  • Hospital Universitario Virgen del Rocío

    Seville

  • Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes

    Vigo

  • Hospital Universitario Miguel Servet

    Zaragoza

Other trials in Spain

Netherlands8 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Amphia Ziekenhuis - Locatie Molengracht Breda

    Breda, 4818 CK

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • Canisius-Wilhelmina ziekenhuis

    Nijmegen

  • Maasstad Ziekenhuis

    Rotterdam, 3078 HT

  • Erasmus Medisch Centrum

    Rotterdam

  • Universitair Medisch Centrum Utrecht

    Utrecht

  • Isala Klinieken - Locatie Weezenlanden

    Zwolle, 8011 JW

Other trials in Netherlands

Canada7 sites

  • London Health Sciences Centre - University Campus

    London

  • McGill Universtiy Health Centre (MUHC)

    Montreal

  • Southlake Regional Health Centre

    Newmarket

  • University of Ottawa Heart Institute

    Ottawa

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

    Québec

  • Royal Columbian Hospital

    Vancouver

  • Vancouver General Hospital

    Vancouver

Other trials in Canada

Italy6 sites

  • Policlinico Sant' Orsola - Malpighi

    Bologna

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia

  • Ospedale Civile Madonna Della Navicella

    Chioggia

  • Azienda Ospedaliera Carlo Poma

    Mantua

  • Azienda Ospedaliero-Universitaria di Parma

    Parma

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona

Other trials in Italy

Poland6 sites

  • Wojewódzki Szpital Zespolony im. Ludwika Perzyny w Kaliszu

    Kalisz

  • Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

    Katowice

  • Regional Hospital Szpital Wojewodski

    Kielce

  • Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

    Lublin

  • Spital Wojewodzki nr 2

    Rzeszów

  • Slaskie Centrum Chorob Serca

    Zabrze

Other trials in Poland

South Korea6 sites

  • Keimyung University Dongsan Medical Center

    Daegu

  • Yeungnam University Medical Center

    Daegu

  • Seoul National University Bundang Hospital

    Gyeonggi-do

  • Kyung Hee University Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

United Kingdom5 sites

  • Golden Jubilee National Hospital - NHS Trust

    Glasgow

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool

  • University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital

    Liverpool

  • Royal Brompton & Harefield NHS Foundation Trust - Royal Brompton Hospital

    London

  • Manchester University NHS Foundation Trust - Wythenshawe Hospital

    Manchester

Other trials in United Kingdom

Australia4 sites

  • Austin Hospital

    Heidelberg, Victoria

  • Fiona Stanley Hospital

    Murdoch, Western Australia

  • John Hunter Hospital

    New Lambton, New South Wales

  • Saint Vincent's Hospital (Sydney)

    Sydney

Other trials in Australia

Saudi Arabia4 sites

  • King Abdul Aziz University Hospital

    Jeddah

  • King Fahad Armed Forces Hospital

    Jeddah

  • King Faisal Specialist Hospital & Research Center

    Riyadh

  • The College of Medicine & King Khalid University Hospital, King Saud University

    Riyadh

Other trials in Saudi Arabia

Portugal3 sites

  • Unidade Local de Saude do Baixo Alentejo, EPE - Hospital José Joaquim Fernandes

    Beja

  • Centro Hospitalar de Coimbra

    Coimbra, 3041-801

  • Hospital de Espírito Santo E.P.E.

    Evora, 7000

Other trials in Portugal

Russia3 sites

  • AV Vishnevsky Institute of Surgery of the Ministry of Health of the Russian Federation

    Moscow

  • EN Meshalkin National medical research center of the Ministry of Health of the Russian Federation

    Novosibirsk

  • Almazov National Medical Research Centre

    Saint Petersburg

Other trials in Russia

Switzerland3 sites

  • Universitätsspital Basel

    Basel, 4031

  • HFR Fribourg - Hôpital cantonal

    Fribourg

  • Kantonsspital St.Gallen

    Sankt Gallen

Other trials in Switzerland

Austria2 sites

  • Landeskrankenhaus Innsbruck - Universitätskliniken

    Innsbruck

  • Allgemeines Krankenhaus der Stadt Linz

    Linz

Other trials in Austria

Belgium2 sites

  • AZ Sint-Jan Brugge-Oostende av

    Bruges

  • Ziekenhuis Oost Limburg - Campus St.-Jan

    Genk

Other trials in Belgium

Finland2 sites

  • Keski-Suomen Keskussairaala

    Jyväskylä

  • Satakunnan keskussairaala

    Pori

Other trials in Finland

Hungary2 sites

  • Magyar Honvédség Honvédkorház

    Budapest

  • Semmelweis Egyetem AOK

    Budapest

Other trials in Hungary

India2 sites

  • Medanta - The Medicity

    Gūrgaon

  • Fortis Escorts Heart Institute

    New Delhi

Other trials in India

Puerto Rico2 sites

  • The Arrhythmia Group

    Coto Laurel

  • Cardiovascular Center

    San Juan

Other trials in Puerto Rico

Slovakia2 sites

  • Stredoslovensky ustav srdcovych a cievnych chorob a.s

    Banská Bystrica

  • NUSCH, a.s.

    Bratislava, 83348

Other trials in Slovakia

Sweden2 sites

  • Karolinska Universitetssjukhuset

    Solna

  • Akademiska Sjukhuset

    Uppsala

Other trials in Sweden

Taiwan2 sites

  • National Taiwan University Hospital Hsin Chu Branch

    Hsinchu, 30059

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

Denmark1 site

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Mexico1 site

  • Hospital Angeles Leon

    León, Guanajuato

Other trials in Mexico

Norway1 site

  • Helse Bergen HF - Haukeland Universitetssjukehus

    Bergen

Other trials in Norway

About this study

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).

Being tested
aCRT ON, aCRT OFF
Keywords
AdaptivCRT, aCRT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aCRT ONDevice

    CRT device with AdaptivCRT enabled (AdaptivBiV and LV)

  • aCRT OFFDevice

    CRT device with AdaptivCRT disabled

Study groups in NCT02205359
Study groupRoleWhat they receive
aCRT ONExperimentalThe aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise
Receives: Device: aCRT ON
aCRT OFFActive comparatorStandard CRT
Receives: Device: aCRT OFF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation

    The first occurrence of death or intervention for heart failure decompensation (defined as an event requiring invasive intervention or inpatient hospitalization).

    Measured: 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 (7)

  1. All-cause Mortality

    All-cause mortality in the aCRT ON group vs the aCRT OFF group

    Measured: from subject randomization until the occurrence of death, median follow-up 4.9 years (max. follow-up 8.1 years)

  2. Percent of Patients With Interventions for Heart Failure Decompensation

    First occurence of intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.

    Measured: 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)

  3. Clinical Composite Score

    The Clinical Composite Score (CCS) classifies patients according their clinical status at 6 months post randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened NYHA class (using last observation carried forward), or worsened status on the Global Assessment Score. Also patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged.

    Measured: CCS at 6 month post randomization

  4. Atrial Fibrillation

    Occurrence of atrial fibrillation lasting >6 hours in one day

    Measured: 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)

  5. Change in Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed. The KCCQ measures Quality of Life on a 0-100 scale with higher scores indicating better QoL

    Measured: from baseline to 24M follow up

  6. Change in Quality of Life Measured by the EQ-5D

    The EQ-5D descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems (labelled 1-3). We calculated the EQ-5D summary index by applying a specific formula providing a valuation to the health states (Shaw et al. Medical Care 2005). For the summary index, value 0 represents health that is valued as equal to death and value 1 represents best possible health.

    Measured: from baseline to 24M follow up

  7. All-cause Re-admissions Within 30 Days After a Heart Failure Admission Per 100 Patient Years

    All-cause hospital re-admissions within 30 days after discharge from a heart failure admission are reported as number of cases per 100 patient years

    Measured: from subject randomization until study exit, median follow-up 4.9 years (max. follow-up 8.1 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2014 (estimated)
  2. Study startAug 2014
  3. Primary completion2 Nov 2022
  4. Study completion2 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
3,797 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02205359
Sponsor's protocol ID
AdaptResponse
Status last verified
Nov 2023
First submitted
18 Jul 2014
Last updated
29 Nov 2023
Data monitoring committee
Yes

Publications

  • Wilkoff BL, Filippatos G, Leclercq C, Gold MR, Hersi AS, Kusano K, Mullens W, Felker GM, Kantipudi C, El-Chami MF, Essebag V, Pierre B, Philippon F, Perez-Gil F, Chung ES, Sotomonte J, Tung S, Singh B, Bozorgnia B, Goel S, Ebert HH, Varma N, Quan KJ, Salerno F, Gerritse B, van Wel J, Schaber DE, Fagan DH, Birnie D; AdaptResponse investigators. Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial. Lancet. 2023 Sep 30;402(10408):1147-1157. doi: 10.1016/S0140-6736(23)00912-1. Epub 2023 Aug 24.

    PubMed 37634520

  • 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.

    PubMed 32790108

  • 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.

    PubMed 28708290

Questions about this trial

What is this clinical trial studying?

A study testing aCRT ON and aCRT OFF in people with Heart Failure With Left Bundle Branch Block, run by Medtronic Cardiac Rhythm and Heart Failure at 220 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 220 sites in United States, France, Germany, Japan, Spain and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02205359, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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