Adaptive Cardiac Resynchronization Therapy Study (aCRT)

September 18, 2018 updated by: Medtronic Cardiac Rhythm and Heart Failure
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

522

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
      • Camperdown, Australia
      • Chermside, Australia
      • Darlinghurst, Australia
      • Perth, Australia
      • Spring Hill, Australia
  • Austria
      • Linz, Austria
  • Belgium
      • Genk, Belgium
      • Leuven, Belgium
      • Yvoir, Belgium
  • Canada
      • Calgary, Canada
      • London, Canada
      • Montreal, Canada
      • Newmarket, Canada
      • Ottawa, Canada
      • Victoria, Canada
  • Denmark
      • Aalborg, Denmark
      • København, Denmark
      • Odense, Denmark
      • Århus, Denmark
  • Germany
      • Bochum, Germany
      • Hamburg, Germany
      • Ludenscheid, Germany
      • Reinbek, Germany
      • Trier, Germany
  • Greece
      • Athens, Greece
  • Hong Kong
      • Hong Kong, Hong Kong
  • Hungary
      • Budapest, Hungary
  • Italy
      • Milano, Italy
      • Pavia, Italy
      • Pedara, Italy
      • Rozzano, Italy
  • Japan
      • Osaka, Japan
      • Tokyo, Japan
      • Tsukuba city, Japan
  • Netherlands
      • Nijmegen, Netherlands
      • Rotterdam, Netherlands
  • Norway
      • Bergen, Norway
      • Oslo, Norway
  • Russian Federation
      • Tyumen, Russian Federation
  • Saudi Arabia
      • Riyadh, Saudi Arabia
  • Serbia
      • Belgrade, Serbia
      • Nis, Serbia
      • Sremska Kamenica, Serbia
  • Spain
      • Albacete, Spain
      • Madrid, Spain
      • Majadahonda, Spain
      • Vitoria-Gasteiz, Spain
  • Sweden
      • Lund, Sweden
      • Stockholm, Sweden
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 36264
    • Alaska
      • Anchorage, Alaska, United States, 36264
    • Arizona
      • Phoenix, Arizona, United States, 36264
    • Arkansas
      • Little Rock, Arkansas, United States, 36264
    • California
      • Glendale, California, United States, 36264
      • San Bernardino, California, United States, 36264
      • San Diego, California, United States, 36264
    • Colorado
      • Colorado Springs, Colorado, United States, 36264
      • Denver, Colorado, United States, 36264
    • Florida
      • Clearwater, Florida, United States, 36264
      • Jacksonville, Florida, United States, 36264
      • Orlando, Florida, United States, 36264
      • Pensacola, Florida, United States, 36264
    • Georgia
      • Augusta, Georgia, United States, 36264
    • Illinois
      • Barrington, Illinois, United States, 36264
    • Indiana
      • Fort Wayne, Indiana, United States, 36264
    • Iowa
      • Davenport, Iowa, United States, 36264
      • Des Moines, Iowa, United States, 36264
    • Kansas
      • Kansas City, Kansas, United States, 36264
    • Kentucky
      • Louisville, Kentucky, United States, 36264
    • Maryland
      • Takoma Park, Maryland, United States, 36264
    • Massachusetts
      • Burlington, Massachusetts, United States, 36264
    • Michigan
      • Detroit, Michigan, United States, 36264
      • Grand Rapids, Michigan, United States, 36264
      • Saginaw, Michigan, United States, 36264
    • Minnesota
      • Saint Cloud, Minnesota, United States, 36264
      • Saint Louis Park, Minnesota, United States, 36264
      • Saint Paul, Minnesota, United States, 36264
    • Mississippi
      • Tupelo, Mississippi, United States, 36264
    • Missouri
      • Kansas City, Missouri, United States, 36264
      • Saint Louis, Missouri, United States, 36264
    • Nebraska
      • Lincoln, Nebraska, United States, 36264
    • New Jersey
      • Morristown, New Jersey, United States, 36264
    • New York
      • Brooklyn, New York, United States, 36264
      • Buffalo, New York, United States, 36264
      • New York, New York, United States, 36264
    • North Carolina
      • Charlotte, North Carolina, United States, 36264
      • Greensboro, North Carolina, United States, 36264
    • Ohio
      • Cleveland, Ohio, United States, 36264
      • Columbus, Ohio, United States, 36264
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 36264
    • Oregon
      • Portland, Oregon, United States, 36264
    • South Carolina
      • Charleston, South Carolina, United States, 36264
      • Spartanburg, South Carolina, United States, 36264
    • Tennessee
      • Chattanooga, Tennessee, United States, 36264
    • Texas
      • Austin, Texas, United States, 36264
      • Dallas, Texas, United States, 36264
      • Tyler, Texas, United States, 36264
    • Vermont
      • Burlington, Vermont, United States, 36264
    • Virginia
      • Norfolk, Virginia, United States, 36264
      • Richmond, Virginia, United States, 36264
    • Washington
      • Bellingham, Washington, United States, 36264
      • Spokane, Washington, United States, 36264
    • West Virginia
      • Morgantown, West Virginia, United States, 36264
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 36264

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Adaptive CRT (aCRT) arm
Intervention: Cardiac resynchronization therapy (CRT-D) with Adaptive CRT algorithm ON
Device: Adaptive CRT (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
Other Names:
  • aCRT
ACTIVE_COMPARATOR: Echo-optimized arm
Intervention: Cardiac resynchronization therapy (CRT-D) with standard biventricular pacing (Adaptive CRT algorithm OFF)
Device: Echo
Standard BiV pacing with settings optimized using a standardized echocardiographic protocol
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score
Time Frame: randomization to six month visit

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
randomization to six month visit
Correlation Between Aortic Velocity Time Integral (AoVTI) at Adaptive CRT and Echo-optimized Device Settings
Time Frame: randomization visit and six month visit
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.
randomization visit and six month visit
Percentage of Patients With a Safety Event (Inappropriate AV or VV Delay Settings Related to the aCRT Feature)
Time Frame: randomization to 6 months post randomization
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)
randomization to 6 months post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right Ventricular Pacing Percentage
Time Frame: implant to six months post randomization
The percentage of time the right ventricle is paced by the device
implant to six months post randomization
Change in Left Ventricular End Systolic Volume Index (LVESVi)
Time Frame: baseline to six month visit
Change in left ventricular end systolic volume index (LVESVi).
baseline to six month visit
Change in Left Ventricular Ejection Fraction (LVEF)
Time Frame: baseline to six month visit
baseline to six month visit
Change in New York Heart Association (NYHA) Classification
Time Frame: baseline to six month visit

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.
baseline to six month visit
Change in Distance Walked During the Six Minute Hall Walk
Time Frame: baseline to six month visit
baseline to six month visit
Change in Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF)
Time Frame: baseline to six month visit
The MLWHF is a 21 question survey. Scores range from 0-105, with lower scores indicating better health.
baseline to six month visit

Collaborators and Investigators

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Study Chair: Adaptive CRT Trial Leader, Medtronic

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 (ACTUAL)

October 1, 2009

Primary Completion (ACTUAL)

August 4, 2011

Study Completion (ACTUAL)

March 8, 2012

Study Registration Dates

First Submitted

September 16, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (ESTIMATE)

September 18, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 16, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adaptive CRT

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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