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Heart FailureaCRTNCT00980057

Adaptive Cardiac Resynchronization Therapy Study

A study testing Adaptive CRT (aCRT) and Echo in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 105 sites in 19 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 study is to demonstrate the AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Adaptive CRT (aCRT) and Echo
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
522 participants
Where
105 sitesin 19 countries
Study dates
1 Oct 2009to 8 Mar 2012
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 Informed Consent form
  • Subject is at least 18 years of age (or older, if required by local law)
  • Subject is expected to remain available for at least six months of follow-up visits
  • Subject is indicated for a study device that will be implanted within 30 days after signing the Informed Consent form
  • Subject has an intrinsic QRS duration greater than or equal to 120 milliseconds (documented within 30 days prior to enrollment)
  • Subject has a left ventricular ejection fraction less than or equal to 35 percent (method per physician discretion) (documented within 180 days prior to enrollment)
  • Subject is diagnosed with New York Heart Association (NYHA) class III or IV (within 30 days prior to enrollment) despite optimal medical therapy which is defined as: ACE-inhibitor (Angiotensin-Converting Enzyme) or Angiotensin II Receptor Blocker (ARB), if tolerated, for at least one month prior to implant, AND beta-blocker for at least three months preceding implant, if tolerated, and stable for one month, OR subject has an urgent medical need for an implantable cardioverter defibrillator (ICD) that precludes waiting the one or three months for the medication requirements for ACE inhibitor, ARB or beta-blocker

Who cannot join

  • Subject has chronic (permanent) atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
  • Subject has existing CRT system
  • Subject has non-intact or unstable leads
  • Subject has medical conditions that would limit study participation (per physician discretion)
  • Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by Medtronic
  • Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) (documented within 30 days prior to enrollment)
Show all 11Show fewer
  • Subject has a mechanical right 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 that would not allow completion of the 6 month visit
  • Subject is pregnant (In the United States, all women of child-bearing potential must undergo a pregnancy test within seven days prior to aCRT download into device)
  • Subject meets the exclusion criteria required by local law

Trial locations and contacts

105 sites in 19 countries.

105 sites in 19 countries

United States55 sites

  • Study site

    Anchorage, Alaska, 36264

  • Study site

    Augusta, Georgia, 36264

  • Study site

    Austin, Texas, 36264

  • Study site

    Barrington, Illinois, 36264

  • Study site

    Bellingham, Washington, 36264

  • Study site

    Brooklyn, New York, 36264

  • Study site

    Buffalo, New York, 36264

  • Study site

    Burlington, Massachusetts, 36264

  • Study site

    Burlington, Vermont, 36264

  • Study site

    Charleston, South Carolina, 36264

  • Study site

    Charlotte, North Carolina, 36264

  • Study site

    Chattanooga, Tennessee, 36264

  • Study site

    Clearwater, Florida, 36264

  • Study site

    Cleveland, Ohio, 36264

  • Study site

    Colorado Springs, Colorado, 36264

  • Study site

    Columbus, Ohio, 36264

  • Study site

    Dallas, Texas, 36264

  • Study site

    Davenport, Iowa, 36264

  • Study site

    Denver, Colorado, 36264

  • Study site

    Des Moines, Iowa, 36264

  • Study site

    Detroit, Michigan, 36264

  • Study site

    Fort Wayne, Indiana, 36264

  • Study site

    Glendale, California, 36264

  • Study site

    Grand Rapids, Michigan, 36264

  • Study site

    Greensboro, North Carolina, 36264

  • Study site

    Huntsville, Alabama, 36264

  • Study site

    Jacksonville, Florida, 36264

  • Study site

    Kansas City, Kansas, 36264

  • Study site

    Kansas City, Missouri, 36264

  • Study site

    Lincoln, Nebraska, 36264

  • Study site

    Little Rock, Arkansas, 36264

  • Study site

    Louisville, Kentucky, 36264

  • Study site

    Milwaukee, Wisconsin, 36264

  • Study site

    Morgantown, West Virginia, 36264

  • Study site

    Morristown, New Jersey, 36264

  • Study site

    New York, New York, 36264

  • Study site

    Norfolk, Virginia, 36264

  • Study site

    Oklahoma City, Oklahoma, 36264

  • Study site

    Orlando, Florida, 36264

  • Study site

    Pensacola, Florida, 36264

  • Study site

    Phoenix, Arizona, 36264

  • Study site

    Portland, Oregon, 36264

  • Study site

    Richmond, Virginia, 36264

  • Study site

    Saginaw, Michigan, 36264

  • Study site

    Saint Cloud, Minnesota, 36264

  • Study site

    Saint Louis Park, Minnesota, 36264

  • Study site

    Saint Paul, Minnesota, 36264

  • Study site

    San Bernardino, California, 36264

  • Study site

    San Diego, California, 36264

  • Study site

    Spartanburg, South Carolina, 36264

  • Study site

    Spokane, Washington, 36264

  • Study site

    St Louis, Missouri, 36264

  • Study site

    Takoma Park, Maryland, 36264

  • Study site

    Tupelo, Mississippi, 36264

  • Study site

    Tyler, Texas, 36264

Other trials in United States

Australia6 sites

  • Study site

    Adelaide

  • Study site

    Camperdown

  • Study site

    Chermside

  • Study site

    Darlinghurst

  • Study site

    Perth

  • Study site

    Spring Hill

Other trials in Australia

Canada6 sites

  • Study site

    Calgary

  • Study site

    London

  • Study site

    Montreal

  • Study site

    Newmarket

  • Study site

    Ottawa

  • Study site

    Victoria

Other trials in Canada

Germany5 sites

  • Study site

    Bochum

  • Study site

    Hamburg

  • Study site

    Lüdenscheid

  • Study site

    Reinbek

  • Study site

    Trier

Other trials in Germany

Denmark4 sites

  • Study site

    Aalborg

  • Study site

    Aarhus

  • Study site

    Copenhagen

  • Study site

    Odense

Other trials in Denmark

Italy4 sites

  • Study site

    Milan

  • Study site

    Pavia

  • Study site

    Pedara

  • Study site

    Rozzano

Other trials in Italy

Spain4 sites

  • Study site

    Albacete

  • Study site

    Madrid

  • Study site

    Majadahonda

  • Study site

    Vitoria-Gasteiz

Other trials in Spain

Belgium3 sites

  • Study site

    Genk

  • Study site

    Leuven

  • Study site

    Yvoir

Other trials in Belgium

Japan3 sites

  • Study site

    Osaka

  • Study site

    Tokyo

  • Study site

    Tsukuba

Other trials in Japan

Serbia3 sites

  • Study site

    Belgrade

  • Study site

    Kamenitz

  • Study site

    Niš

Other trials in Serbia

Netherlands2 sites

  • Study site

    Nijmegen

  • Study site

    Rotterdam

Other trials in Netherlands

Norway2 sites

  • Study site

    Bergen

  • Study site

    Oslo

Other trials in Norway

Sweden2 sites

  • Study site

    Lund

  • Study site

    Stockholm

Other trials in Sweden

Austria1 site

  • Study site

    Linz

Other trials in Austria

Greece1 site

  • Study site

    Athens

Other trials in Greece

Hong Kong1 site

  • Study site

    Hong Kong

Other trials in Hong Kong

Hungary1 site

  • Study site

    Budapest

Other trials in Hungary

Russia1 site

  • Study site

    Tyumen

Other trials in Russia

Saudi Arabia1 site

  • Study site

    Riyadh

Other trials in Saudi Arabia

About this study

The purpose of this study is to demonstrate the AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance

Read the detailed description

The trial has 3 primary end points:

  • to demonstrate that over 6-month follow-up, the proportion of the patients improved in the aCRT arm is at least as high as in the Echo arm
  • to demonstrate that cardiac function is similar when using aCRT versus echo-optimized settings
  • to demonstrate that aCRT does not result in inappropriate AV or VV delay settings
Conditions
Heart Failure
Being tested
Adaptive CRT (aCRT), Echo
Medical subject headings
Heart Failure

What participants receive

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

  • Adaptive CRT (aCRT)Device

    Also called aCRT

    Adaptive CRT (aCRT) is an algorithm, which provides ambulatory adjustment of pacing configuration (LV-only or BiV) and AV and VV delays based on periodic automatic evaluation of electrical conduction to optimize cardiac function

  • EchoDevice

    Also called Control

    Standard BiV pacing with settings optimized using a standardized echocardiographic protocol

Study groups in NCT00980057
Study groupRoleWhat they receive
Adaptive CRT (aCRT) armExperimentalIntervention: Cardiac resynchronization therapy (CRT-D) with Adaptive CRT algorithm ON
Receives: Device: Adaptive CRT (aCRT)
Echo-optimized armActive comparatorIntervention: Cardiac resynchronization therapy (CRT-D) with standard biventricular pacing (Adaptive CRT algorithm OFF)
Receives: Device: Echo

What is being measured

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

  1. Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score

    Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse on 'patient global assessment' compared to before CRT implant. Patients are improved if they are not worsened and have an improved NYHA or reported moderately/markedly improved on the 'patient global assessment' compared to before CRT implant

    Global assessment question for the patient: Specifically in reference to your heart failure symptoms, how do you feel today as compared to how you felt before your CRT system was implanted? O Markedly improved O Moderately improved O Mildly improved O No change O Slightly worse O Moderately worse O Markedly worse

    Measured: randomization to six month visit

  2. Correlation Between Aortic Velocity Time Integral (AoVTI) at Adaptive CRT and Echo-optimized Device Settings

    Correlation between aortic velocity time integral (AoVTI) at Adaptive CRT and echo-optimized device settings. AoVTI is an echocardiographic representative of stroke volume and cardiac performance.

    Measured: randomization visit and six month visit

  3. Percentage of Patients With a Safety Event (Inappropriate AV or VV Delay Settings Related to the aCRT Feature)

    For each subject, the Adaptive CRT-determined AV and VV delay settings from randomization up to 183-days post-randomization were evaluated to identify any period of 28-days with a wide delay range (>60 ms)

    Measured: randomization to 6 months post randomization

Secondary outcomes (6)

  1. Right Ventricular Pacing Percentage

    The percentage of time the right ventricle is paced by the device

    Measured: implant to six months post randomization

  2. Change in Left Ventricular End Systolic Volume Index (LVESVi)

    Change in left ventricular end systolic volume index (LVESVi).

    Measured: baseline to six month visit

  3. Change in Left Ventricular Ejection Fraction (LVEF)

    Measured: baseline to six month visit

  4. Change in New York Heart Association (NYHA) Classification

    The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity.

    Class - Patient Symptoms I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

    II- Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

    III- Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

    IV- Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

    Measured: baseline to six month visit

  5. Change in Distance Walked During the Six Minute Hall Walk

    Measured: baseline to six month visit

  6. Change in Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF)

    The MLWHF is a 21 question survey. Scores range from 0-105, with lower scores indicating better health.

    Measured: baseline to six month visit

Timeline

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

  1. First posted18 Sep 2009 (estimated)
  2. Study start1 Oct 2009
  3. Primary completion4 Aug 2011
  4. Study completion8 Mar 2012

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
Double blind
Who is masked
Participant, Investigator
Enrolment
522 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00980057
Sponsor's protocol ID
Adaptive CRT
Acronym
aCRT
Status last verified
Sep 2018
First submitted
16 Sep 2009
Last updated
16 Oct 2018
Data monitoring committee
No

Publications

  • Gasparini M, Birnie D, Lemke B, Aonuma K, Lee KL, Gorcsan J 3rd, Landolina M, Klepfer R, Meloni S, Cicconelli M, Grammatico A, Martin DO. Adaptive Cardiac Resynchronization Therapy Reduces Atrial Fibrillation Incidence in Heart Failure Patients With Prolonged AV Conduction: The Adaptive CRT Randomized Trial. Circ Arrhythm Electrophysiol. 2019 May;12(5):e007260. doi: 10.1161/CIRCEP.119.007260. No abstract available.

    PubMed 30991823

  • Birnie D, Hudnall H, Lemke B, Aonuma K, Lee KL, Gasparini M, Gorcsan J 3rd, Cerkvenik J, Martin DO. Continuous optimization of cardiac resynchronization therapy reduces atrial fibrillation in heart failure patients: Results of the Adaptive Cardiac Resynchronization Therapy Trial. Heart Rhythm. 2017 Dec;14(12):1820-1825. doi: 10.1016/j.hrthm.2017.08.017. Epub 2017 Sep 9.

    PubMed 28893549

  • Yamasaki H, Lustgarten D, Cerkvenik J, Birnie D, Gasparini M, Lee KL, Sekiguchi Y, Varma N, Lemke B, Starling RC, Aonuma K. Adaptive CRT in patients with normal AV conduction and left bundle branch block: Does QRS duration matter? Int J Cardiol. 2017 Aug 1;240:297-301. doi: 10.1016/j.ijcard.2017.04.036. Epub 2017 Apr 12.

    PubMed 28416247

  • Starling RC, Krum H, Bril S, Tsintzos SI, Rogers T, Hudnall JH, Martin DO. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. 2015 Jul;3(7):565-572. doi: 10.1016/j.jchf.2015.03.001. Epub 2015 Jun 10.

    PubMed 26071616

  • Birnie D, Lemke B, Aonuma K, Krum H, Lee KL, Gasparini M, Starling RC, Milasinovic G, Gorcsan J 3rd, Houmsse M, Abeyratne A, Sambelashvili A, Martin DO. Clinical outcomes with synchronized left ventricular pacing: analysis of the adaptive CRT trial. Heart Rhythm. 2013 Sep;10(9):1368-74. doi: 10.1016/j.hrthm.2013.07.007. Epub 2013 Jul 11.

    PubMed 23851059

  • Krum H, Lemke B, Birnie D, Lee KL, Aonuma K, Starling RC, Gasparini M, Gorcsan J, Rogers T, Sambelashvili A, Kalmes A, Martin D. A novel algorithm for individualized cardiac resynchronization therapy: rationale and design of the adaptive cardiac resynchronization therapy trial. Am Heart J. 2012 May;163(5):747-752.e1. doi: 10.1016/j.ahj.2012.02.007.

    PubMed 22607850

Questions about this trial

What is this clinical trial studying?

A study testing Adaptive CRT (aCRT) and Echo in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 105 sites in 19 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Australia, Canada, Germany, Denmark and 14 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 16 Oct 2018). 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?

Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score (time frame: randomization to six month visit). The study lists 3 primary outcomes in all. 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 NCT00980057, which also lists 6 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 16 Oct 2018.

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Adaptive Cardiac Resynchronization Therapy Study | AzTrials