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aCRT: Adaptive Cardiac Resynchronization Therapy Study

Sponsor
Medtronic Cardiac Rhythm and Heart Failure (Industry)
Overall Status
Completed
CT.gov ID
NCT00980057
Collaborator
(none)
522
Enrollment
105
Locations
2
Arms
29.2
Actual Duration (Months)
5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: Adaptive CRT (aCRT)
  • Device: Echo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
522 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Adaptive Cardiac Resynchronization Therapy Study
Actual Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Aug 4, 2011
Actual Study Completion Date :
Mar 8, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

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

    Secondary Outcome Measures

    1. Right Ventricular Pacing Percentage [implant to six months post randomization]

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

    2. Change in Left Ventricular End Systolic Volume Index (LVESVi) [baseline to six month visit]

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

    3. Change in Left Ventricular Ejection Fraction (LVEF) [baseline to six month visit]

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

    5. Change in Distance Walked During the Six Minute Hall Walk [baseline to six month visit]

    6. Change in Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF) [baseline to six month visit]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Huntsville Alabama United States 36264
    2 Anchorage Alaska United States 36264
    3 Phoenix Arizona United States 36264
    4 Little Rock Arkansas United States 36264
    5 Glendale California United States 36264
    6 San Bernardino California United States 36264
    7 San Diego California United States 36264
    8 Colorado Springs Colorado United States 36264
    9 Denver Colorado United States 36264
    10 Clearwater Florida United States 36264
    11 Jacksonville Florida United States 36264
    12 Orlando Florida United States 36264
    13 Pensacola Florida United States 36264
    14 Augusta Georgia United States 36264
    15 Barrington Illinois United States 36264
    16 Fort Wayne Indiana United States 36264
    17 Davenport Iowa United States 36264
    18 Des Moines Iowa United States 36264
    19 Kansas City Kansas United States 36264
    20 Louisville Kentucky United States 36264
    21 Takoma Park Maryland United States 36264
    22 Burlington Massachusetts United States 36264
    23 Detroit Michigan United States 36264
    24 Grand Rapids Michigan United States 36264
    25 Saginaw Michigan United States 36264
    26 Saint Cloud Minnesota United States 36264
    27 Saint Louis Park Minnesota United States 36264
    28 Saint Paul Minnesota United States 36264
    29 Tupelo Mississippi United States 36264
    30 Kansas City Missouri United States 36264
    31 Saint Louis Missouri United States 36264
    32 Lincoln Nebraska United States 36264
    33 Morristown New Jersey United States 36264
    34 Brooklyn New York United States 36264
    35 Buffalo New York United States 36264
    36 New York New York United States 36264
    37 Charlotte North Carolina United States 36264
    38 Greensboro North Carolina United States 36264
    39 Cleveland Ohio United States 36264
    40 Columbus Ohio United States 36264
    41 Oklahoma City Oklahoma United States 36264
    42 Portland Oregon United States 36264
    43 Charleston South Carolina United States 36264
    44 Spartanburg South Carolina United States 36264
    45 Chattanooga Tennessee United States 36264
    46 Austin Texas United States 36264
    47 Dallas Texas United States 36264
    48 Tyler Texas United States 36264
    49 Burlington Vermont United States 36264
    50 Norfolk Virginia United States 36264
    51 Richmond Virginia United States 36264
    52 Bellingham Washington United States 36264
    53 Spokane Washington United States 36264
    54 Morgantown West Virginia United States 36264
    55 Milwaukee Wisconsin United States 36264
    56 Adelaide Australia
    57 Camperdown Australia
    58 Chermside Australia
    59 Darlinghurst Australia
    60 Perth Australia
    61 Spring Hill Australia
    62 Linz Austria
    63 Genk Belgium
    64 Leuven Belgium
    65 Yvoir Belgium
    66 Calgary Canada
    67 London Canada
    68 Montreal Canada
    69 Newmarket Canada
    70 Ottawa Canada
    71 Victoria Canada
    72 Aalborg Denmark
    73 København Denmark
    74 Odense Denmark
    75 Århus Denmark
    76 Bochum Germany
    77 Hamburg Germany
    78 Ludenscheid Germany
    79 Reinbek Germany
    80 Trier Germany
    81 Athens Greece
    82 Hong Kong Hong Kong
    83 Budapest Hungary
    84 Milano Italy
    85 Pavia Italy
    86 Pedara Italy
    87 Rozzano Italy
    88 Osaka Japan
    89 Tokyo Japan
    90 Tsukuba city Japan
    91 Nijmegen Netherlands
    92 Rotterdam Netherlands
    93 Bergen Norway
    94 Oslo Norway
    95 Tyumen Russian Federation
    96 Riyadh Saudi Arabia
    97 Belgrade Serbia
    98 Nis Serbia
    99 Sremska Kamenica Serbia
    100 Albacete Spain
    101 Madrid Spain
    102 Majadahonda Spain
    103 Vitoria-Gasteiz Spain
    104 Lund Sweden
    105 Stockholm Sweden

    Sponsors and Collaborators

    • Medtronic Cardiac Rhythm and Heart Failure

    Investigators

    • Study Chair: Adaptive CRT Trial Leader, Medtronic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic Cardiac Rhythm and Heart Failure
    ClinicalTrials.gov Identifier:
    NCT00980057
    Other Study ID Numbers:
    • Adaptive CRT
    First Posted:
    Sep 18, 2009
    Last Update Posted:
    Oct 16, 2018
    Last Verified:
    Sep 1, 2018
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Total number of: 522 pts enrolled, 1 exit 521 pts with baseline information, 16 exits 505 pts of which 14 unsuccessful implants and 491 successful implants, 12 exits and 1 death 478 randomized (318 to aCRT, 160 to control)
    Arm/Group Title Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing
    Arm/Group Description Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)
    Period Title: Overall Study
    STARTED 318 160
    COMPLETED 299 155
    NOT COMPLETED 19 5

    Baseline Characteristics

    Arm/Group Title Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing Total
    Arm/Group Description Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Total of all reporting groups
    Overall Participants 318 160 478
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65.4
    (11.2)
    66.2
    (9.7)
    65.7
    (10.7)
    Sex: Female, Male (Count of Participants)
    Female
    97
    30.5%
    51
    31.9%
    148
    31%
    Male
    221
    69.5%
    109
    68.1%
    330
    69%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    8
    2.5%
    3
    1.9%
    11
    2.3%
    Black or African American
    29
    9.1%
    6
    3.8%
    35
    7.3%
    Hispanic or Latino
    13
    4.1%
    5
    3.1%
    18
    3.8%
    Native Hawaiian or Pacific Islander
    0
    0%
    1
    0.6%
    1
    0.2%
    White or Caucasian
    257
    80.8%
    139
    86.9%
    396
    82.8%
    Two or more races
    3
    0.9%
    1
    0.6%
    4
    0.8%
    Other race
    0
    0%
    0
    0%
    0
    0%
    Not available
    7
    2.2%
    5
    3.1%
    12
    2.5%
    Region of Enrollment (participants) [Number]
    Russia
    1
    0.3%
    0
    0%
    1
    0.2%
    Hong Kong
    2
    0.6%
    1
    0.6%
    3
    0.6%
    United States
    176
    55.3%
    87
    54.4%
    263
    55%
    Japan
    4
    1.3%
    2
    1.3%
    6
    1.3%
    Spain
    1
    0.3%
    0
    0%
    1
    0.2%
    Saudi Arabia
    1
    0.3%
    1
    0.6%
    2
    0.4%
    Canada
    17
    5.3%
    8
    5%
    25
    5.2%
    Austria
    5
    1.6%
    2
    1.3%
    7
    1.5%
    Netherlands
    11
    3.5%
    5
    3.1%
    16
    3.3%
    Sweden
    2
    0.6%
    2
    1.3%
    4
    0.8%
    Belgium
    6
    1.9%
    3
    1.9%
    9
    1.9%
    Norway
    7
    2.2%
    3
    1.9%
    10
    2.1%
    Denmark
    11
    3.5%
    7
    4.4%
    18
    3.8%
    Italy
    3
    0.9%
    2
    1.3%
    5
    1%
    Australia
    18
    5.7%
    12
    7.5%
    30
    6.3%
    Serbia
    23
    7.2%
    10
    6.3%
    33
    6.9%
    Germany
    31
    9.7%
    14
    8.8%
    45
    9.4%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score
    Description 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
    Time Frame randomization to six month visit

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing
    Arm/Group Description Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)
    Measure Participants 318 160
    Count of Participants [Participants]
    234
    73.6%
    114
    71.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Adaptive CRT (aCRT) Pacing, Standard Biventricular Pacing
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority margin was 12%.
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Farrington-Manning test of two ind. prop
    Comments
    2. Primary Outcome
    Title Correlation Between Aortic Velocity Time Integral (AoVTI) at Adaptive CRT and Echo-optimized Device Settings
    Description 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.
    Time Frame randomization visit and six month visit

    Outcome Measure Data

    Analysis Population Description
    Concordance correlations have been calculated between AoVTI at Adaptive CRT AV and VV settings vs. echo-optimized AV and VV settings at randomization and 6 M. Paired AoVTI measurements were used for concordance correlation analysis, where each subject served as his/her own control. AoVTI was not obtained at both settings for 79 patients.
    Arm/Group Title All Randomized Patients
    Arm/Group Description The AoVTI was calculated for each Adaptive CRT subject under two different parameter settings: AV and VV settings determined by Adaptive CRT, and AV and VV settings determined by echo-optimization. Subsequently a concordance correlation was calculated and reported, thus this measure cannot be reported per treatment arm.
    Measure Participants 399
    Number (95% Confidence Interval) [Concordance correlation coefficient]
    0.93
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Adaptive CRT (aCRT) Pacing
    Comments
    Type of Statistical Test Superiority
    Comments The pre-specified minimum objective performance criteria was 0.82
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 1 sided
    Comments
    3. Primary Outcome
    Title Percentage of Patients With a Safety Event (Inappropriate AV or VV Delay Settings Related to the aCRT Feature)
    Description 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)
    Time Frame randomization to 6 months post randomization

    Outcome Measure Data

    Analysis Population Description
    17 participants did not have data available for analysis of this endpoint.
    Arm/Group Title Adaptive CRT (aCRT) Pacing
    Arm/Group Description Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status
    Measure Participants 301
    Count of Participants [Participants]
    0
    0%
    4. Secondary Outcome
    Title Right Ventricular Pacing Percentage
    Description The percentage of time the right ventricle is paced by the device
    Time Frame implant to six months post randomization

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing
    Arm/Group Description Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)
    Measure Participants 314 160
    Mean (Standard Deviation) [percentage of right ventricle pacing]
    51.3
    (37.9)
    95.1
    (10.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Adaptive CRT (aCRT) Pacing, Standard Biventricular Pacing
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 2 sided
    Comments
    5. Secondary Outcome
    Title Change in Left Ventricular End Systolic Volume Index (LVESVi)
    Description Change in left ventricular end systolic volume index (LVESVi).
    Time Frame baseline to six month visit

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing
    Arm/Group Description Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)
    Measure Participants 250 123
    Mean (Standard Deviation) [milliliters per meter squared]
    -8.3
    (23.3)
    -10.5
    (24.2)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Adaptive CRT (aCRT) Pacing, Standard Biventricular Pacing
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority margin is 15
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 1 sided
    Comments
    6. Secondary Outcome
    Title Change in Left Ventricular Ejection Fraction (LVEF)
    Description
    Time Frame baseline to six month visit

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing
    Arm/Group Description Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)
    Measure Participants 250 123
    Mean (Standard Deviation) [percent]
    3.9
    (10.0)
    2.9
    (9.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Adaptive CRT (aCRT) Pacing, Standard Biventricular Pacing
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority margin is 2.5
    Statistical Test of Hypothesis p-Value 0.0009
    Comments
    Method t-test, 1 sided
    Comments
    7. Secondary Outcome
    Title Change in New York Heart Association (NYHA) Classification
    Description 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.
    Time Frame baseline to six month visit

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing
    Arm/Group Description Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)
    Measure Participants 296 153
    Mean (Standard Deviation) [NYHA class]
    -1.0
    (0.8)
    -0.8
    (0.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Adaptive CRT (aCRT) Pacing, Standard Biventricular Pacing
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority margin is 0.3
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 1 sided
    Comments
    8. Secondary Outcome
    Title Change in Distance Walked During the Six Minute Hall Walk
    Description
    Time Frame baseline to six month visit

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing
    Arm/Group Description Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)
    Measure Participants 284 142
    Mean (Standard Deviation) [meters]
    42.4
    (103.3)
    29.0
    (123.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Adaptive CRT (aCRT) Pacing, Standard Biventricular Pacing
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority margin is 30
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method t-test, 1 sided
    Comments
    9. Secondary Outcome
    Title Change in Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF)
    Description The MLWHF is a 21 question survey. Scores range from 0-105, with lower scores indicating better health.
    Time Frame baseline to six month visit

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing
    Arm/Group Description Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)
    Measure Participants 261 135
    Mean (Standard Deviation) [units on a scale]
    -19.3
    (20.7)
    -17.6
    (23.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Adaptive CRT (aCRT) Pacing, Standard Biventricular Pacing
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority margin is 5.1
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method t-test, 1 sided
    Comments

    Adverse Events

    Time Frame From randomization to the end of the study, which was 31.3 months for the longest-randomized patient. The average follow-up time was 20.2 months.
    Adverse Event Reporting Description
    Arm/Group Title Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing
    Arm/Group Description Cardiac resynchronization therapy (CRT) with adaptive pacing Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D) Adaptive CRT (aCRT) Pacing: Adaptive CRT pacing software adjusts how the device paces the heart based on the patient's current heart status Cardiac resynchronization therapy (CRT) with biventricular pacing only (without adaptive pacing) Cardiac Resynchronization Therapy-Defibrillator (CRT-D): Market approved Medtronic Vision 3D™ CRT-D implantable device (Consulta® CRT-D, Maximo II® CRT-D, or Concerto II® CRT-D)
    All Cause Mortality
    Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 35/318 (11%) 19/160 (11.9%)
    Serious Adverse Events
    Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 158/318 (49.7%) 86/160 (53.8%)
    Blood and lymphatic system disorders
    Anaemia 4/318 (1.3%) 4 6/160 (3.8%) 6
    Coagulopathy 0/318 (0%) 0 1/160 (0.6%) 1
    Iron deficiency anaemia 1/318 (0.3%) 1 0/160 (0%) 0
    Splenic infarction 1/318 (0.3%) 1 0/160 (0%) 0
    Thrombocytopenia 0/318 (0%) 0 1/160 (0.6%) 1
    Cardiac disorders
    Acute coronary syndrome 0/318 (0%) 0 1/160 (0.6%) 1
    Acute myocardial infarction 4/318 (1.3%) 4 2/160 (1.3%) 2
    Angina pectoris 3/318 (0.9%) 3 1/160 (0.6%) 1
    Angina unstable 1/318 (0.3%) 1 0/160 (0%) 0
    Aortic valve stenosis 1/318 (0.3%) 1 0/160 (0%) 0
    Arrhythmia supraventricular 1/318 (0.3%) 1 0/160 (0%) 0
    Atrial fibrillation 4/318 (1.3%) 5 5/160 (3.1%) 8
    Atrial flutter 4/318 (1.3%) 5 0/160 (0%) 0
    Cardiac arrest 4/318 (1.3%) 4 1/160 (0.6%) 1
    Cardiac failure 63/318 (19.8%) 112 35/160 (21.9%) 58
    Cardiac failure chronic 1/318 (0.3%) 1 0/160 (0%) 0
    Cardiac tamponade 1/318 (0.3%) 1 0/160 (0%) 0
    Cardio-respiratory arrest 0/318 (0%) 0 1/160 (0.6%) 1
    Cardiogenic shock 1/318 (0.3%) 1 1/160 (0.6%) 1
    Coronary artery disease 7/318 (2.2%) 7 0/160 (0%) 0
    Heart valve incompetence 1/318 (0.3%) 1 0/160 (0%) 0
    Intracardiac thrombus 1/318 (0.3%) 1 3/160 (1.9%) 3
    Mitral valve incompetence 1/318 (0.3%) 1 0/160 (0%) 0
    Myocardial infarction 2/318 (0.6%) 3 0/160 (0%) 0
    Pericardial effusion 2/318 (0.6%) 2 0/160 (0%) 0
    Pulseless electrical activity 0/318 (0%) 0 1/160 (0.6%) 1
    Sinus tachycardia 0/318 (0%) 0 1/160 (0.6%) 1
    Supraventricular tachyarrhythmia 0/318 (0%) 0 1/160 (0.6%) 1
    Supraventricular tachycardia 3/318 (0.9%) 3 0/160 (0%) 0
    Tachycardia 0/318 (0%) 0 1/160 (0.6%) 1
    Tricuspid valve disease 1/318 (0.3%) 1 0/160 (0%) 0
    Tricuspid valve incompetence 0/318 (0%) 0 1/160 (0.6%) 1
    Ventricular arrhythmia 1/318 (0.3%) 1 1/160 (0.6%) 1
    Ventricular fibrillation 2/318 (0.6%) 2 1/160 (0.6%) 1
    Ventricular tachyarrhythmia 1/318 (0.3%) 1 0/160 (0%) 0
    Ventricular tachycardia 8/318 (2.5%) 8 4/160 (2.5%) 6
    Congenital, familial and genetic disorders
    Atrial septal defect 0/318 (0%) 0 1/160 (0.6%) 1
    Ear and labyrinth disorders
    Vertigo 0/318 (0%) 0 1/160 (0.6%) 1
    Vertigo positional 0/318 (0%) 0 1/160 (0.6%) 1
    Eye disorders
    Cataract 1/318 (0.3%) 1 0/160 (0%) 0
    Gastrointestinal disorders
    Ascites 1/318 (0.3%) 1 0/160 (0%) 0
    Colitis 1/318 (0.3%) 1 0/160 (0%) 0
    Colonic polyp 0/318 (0%) 0 1/160 (0.6%) 1
    Constipation 1/318 (0.3%) 1 0/160 (0%) 0
    Diarrhoea 1/318 (0.3%) 1 1/160 (0.6%) 1
    Diverticular perforation 1/318 (0.3%) 1 0/160 (0%) 0
    Dysphagia 1/318 (0.3%) 1 0/160 (0%) 0
    Enterocutaneous fistula 1/318 (0.3%) 1 0/160 (0%) 0
    Food poisoning 1/318 (0.3%) 1 0/160 (0%) 0
    Gastric haemorrhage 1/318 (0.3%) 1 0/160 (0%) 0
    Gastritis 1/318 (0.3%) 1 2/160 (1.3%) 2
    Gastrointestinal haemorrhage 4/318 (1.3%) 4 4/160 (2.5%) 5
    Haematochezia 0/318 (0%) 0 1/160 (0.6%) 1
    Inguinal hernia 1/318 (0.3%) 1 0/160 (0%) 0
    Intestinal ischaemia 1/318 (0.3%) 1 0/160 (0%) 0
    Intestinal obstruction 1/318 (0.3%) 1 0/160 (0%) 0
    Pancreatitis acute 1/318 (0.3%) 1 0/160 (0%) 0
    Peptic ulcer 0/318 (0%) 0 1/160 (0.6%) 1
    Peritoneal haemorrhage 1/318 (0.3%) 1 0/160 (0%) 0
    Rectal haemorrhage 1/318 (0.3%) 1 0/160 (0%) 0
    Vomiting 0/318 (0%) 0 1/160 (0.6%) 2
    General disorders
    Asthenia 1/318 (0.3%) 1 0/160 (0%) 0
    Chest discomfort 1/318 (0.3%) 1 0/160 (0%) 0
    Chest pain 6/318 (1.9%) 6 4/160 (2.5%) 4
    Device capturing issue 1/318 (0.3%) 1 0/160 (0%) 0
    Device connection issue 0/318 (0%) 0 2/160 (1.3%) 2
    Device dislocation 11/318 (3.5%) 11 7/160 (4.4%) 10
    Device electrical impedance issue 1/318 (0.3%) 1 0/160 (0%) 0
    Device lead damage 1/318 (0.3%) 1 1/160 (0.6%) 1
    Device misuse 1/318 (0.3%) 1 1/160 (0.6%) 1
    Device pacing issue 0/318 (0%) 0 1/160 (0.6%) 1
    Device psychogenic complication 0/318 (0%) 0 1/160 (0.6%) 1
    Device stimulation issue 2/318 (0.6%) 2 2/160 (1.3%) 2
    Hernia 1/318 (0.3%) 1 0/160 (0%) 0
    Implant site haematoma 2/318 (0.6%) 2 1/160 (0.6%) 1
    Implant site pain 1/318 (0.3%) 1 0/160 (0%) 0
    Multi-organ failure 1/318 (0.3%) 1 1/160 (0.6%) 1
    Non-cardiac chest pain 1/318 (0.3%) 1 2/160 (1.3%) 2
    Polyp 0/318 (0%) 0 1/160 (0.6%) 1
    Sudden cardiac death 2/318 (0.6%) 2 1/160 (0.6%) 1
    Undersensing 0/318 (0%) 0 1/160 (0.6%) 1
    Hepatobiliary disorders
    Cholecystitis 0/318 (0%) 0 1/160 (0.6%) 1
    Cholecystitis acute 1/318 (0.3%) 1 0/160 (0%) 0
    Immune system disorders
    Hypersensitivity 0/318 (0%) 0 1/160 (0.6%) 1
    Infections and infestations
    Anal abscess 0/318 (0%) 0 1/160 (0.6%) 1
    Bacterial infection 1/318 (0.3%) 1 0/160 (0%) 0
    Bronchitis 4/318 (1.3%) 4 1/160 (0.6%) 1
    Bronchopneumonia 0/318 (0%) 0 1/160 (0.6%) 1
    Campylobacter gastroenteritis 0/318 (0%) 0 1/160 (0.6%) 1
    Cellulitis 2/318 (0.6%) 2 3/160 (1.9%) 3
    Clostridium difficile colitis 1/318 (0.3%) 1 0/160 (0%) 0
    Device related infection 1/318 (0.3%) 1 0/160 (0%) 0
    Empyema 0/318 (0%) 0 1/160 (0.6%) 1
    Gastroenteritis 0/318 (0%) 0 1/160 (0.6%) 1
    Gastroenteritis viral 0/318 (0%) 0 1/160 (0.6%) 1
    Implant site infection 1/318 (0.3%) 1 4/160 (2.5%) 4
    Infection 0/318 (0%) 0 2/160 (1.3%) 2
    Influenza 1/318 (0.3%) 1 0/160 (0%) 0
    Liver abscess 1/318 (0.3%) 1 0/160 (0%) 0
    Lower respiratory tract infection 1/318 (0.3%) 1 0/160 (0%) 0
    Parotitis 1/318 (0.3%) 1 0/160 (0%) 0
    Pelvic abscess 1/318 (0.3%) 1 0/160 (0%) 0
    Pneumonia 16/318 (5%) 19 9/160 (5.6%) 12
    Postoperative wound infection 1/318 (0.3%) 1 1/160 (0.6%) 2
    Respiratory tract infection 1/318 (0.3%) 1 0/160 (0%) 0
    Sepsis 7/318 (2.2%) 9 2/160 (1.3%) 2
    Septic shock 2/318 (0.6%) 2 0/160 (0%) 0
    Staphylococcal infection 1/318 (0.3%) 1 0/160 (0%) 0
    Upper respiratory tract infection 1/318 (0.3%) 1 0/160 (0%) 0
    Urinary tract infection 4/318 (1.3%) 4 4/160 (2.5%) 4
    Urosepsis 2/318 (0.6%) 2 1/160 (0.6%) 1
    Wound infection pseudomonas 1/318 (0.3%) 1 0/160 (0%) 0
    Injury, poisoning and procedural complications
    Arteriovenous fistula occlusion 1/318 (0.3%) 1 0/160 (0%) 0
    Fall 0/318 (0%) 0 1/160 (0.6%) 1
    Fracture 0/318 (0%) 0 1/160 (0.6%) 1
    Head injury 0/318 (0%) 0 1/160 (0.6%) 1
    Hip fracture 1/318 (0.3%) 1 1/160 (0.6%) 1
    Lumbar vertebral fracture 1/318 (0.3%) 1 0/160 (0%) 0
    Pocket erosion 1/318 (0.3%) 1 0/160 (0%) 0
    Post procedural haemorrhage 0/318 (0%) 0 1/160 (0.6%) 1
    Post-traumatic neck syndrome 0/318 (0%) 0 1/160 (0.6%) 1
    Spinal compression fracture 0/318 (0%) 0 1/160 (0.6%) 1
    Investigations
    Blood bilirubin abnormal 1/318 (0.3%) 1 0/160 (0%) 0
    Clostridium test positive 1/318 (0.3%) 2 0/160 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 4/318 (1.3%) 4 2/160 (1.3%) 2
    Diabetes mellitus 2/318 (0.6%) 2 0/160 (0%) 0
    Hyperglycaemia 2/318 (0.6%) 2 3/160 (1.9%) 3
    Hyperkalaemia 2/318 (0.6%) 2 1/160 (0.6%) 1
    Hypernatraemia 0/318 (0%) 0 1/160 (0.6%) 1
    Hypoglycaemia 0/318 (0%) 0 3/160 (1.9%) 3
    Hyponatraemia 0/318 (0%) 0 3/160 (1.9%) 3
    Hypovolaemia 0/318 (0%) 0 1/160 (0.6%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/318 (0.3%) 1 0/160 (0%) 0
    Cervical spinal stenosis 1/318 (0.3%) 1 0/160 (0%) 0
    Flank pain 1/318 (0.3%) 1 0/160 (0%) 0
    Gouty arthritis 0/318 (0%) 0 2/160 (1.3%) 2
    Musculoskeletal chest pain 0/318 (0%) 0 1/160 (0.6%) 1
    Neck pain 1/318 (0.3%) 1 0/160 (0%) 0
    Osteoarthritis 1/318 (0.3%) 2 1/160 (0.6%) 1
    Pain in jaw 1/318 (0.3%) 1 0/160 (0%) 0
    Rhabdomyolysis 0/318 (0%) 0 1/160 (0.6%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gallbladder cancer 1/318 (0.3%) 1 0/160 (0%) 0
    Hepatic neoplasm malignant 0/318 (0%) 0 1/160 (0.6%) 2
    Non-Hodgkin's lymphoma 1/318 (0.3%) 1 0/160 (0%) 0
    Gastric cancer 1/318 (0.3%) 1 0/160 (0%) 0
    Lung neoplasm malignant 2/318 (0.6%) 2 2/160 (1.3%) 2
    Lymphoma 1/318 (0.3%) 1 0/160 (0%) 0
    Metastases to gastrointestinal tract 1/318 (0.3%) 1 0/160 (0%) 0
    Neoplasm malignant 1/318 (0.3%) 1 0/160 (0%) 0
    Nervous system disorders
    Carotid artery stenosis 1/318 (0.3%) 1 0/160 (0%) 0
    Cerebellar infarction 0/318 (0%) 0 1/160 (0.6%) 1
    Cerebral infarction 0/318 (0%) 0 1/160 (0.6%) 1
    Cerebrovascular accident 0/318 (0%) 0 2/160 (1.3%) 2
    Cervical root pain 1/318 (0.3%) 1 0/160 (0%) 0
    Dementia 1/318 (0.3%) 1 0/160 (0%) 0
    Encephalopathy 2/318 (0.6%) 2 0/160 (0%) 0
    Haemorrhage intracranial 1/318 (0.3%) 1 0/160 (0%) 0
    Headache 0/318 (0%) 0 1/160 (0.6%) 1
    Nerve compression 1/318 (0.3%) 1 0/160 (0%) 0
    Presyncope 2/318 (0.6%) 2 0/160 (0%) 0
    Subarachnoid haemorrhage 1/318 (0.3%) 1 0/160 (0%) 0
    Syncope 2/318 (0.6%) 2 1/160 (0.6%) 2
    Transient ischaemic attack 3/318 (0.9%) 3 0/160 (0%) 0
    Renal and urinary disorders
    Obstructive uropathy 0/318 (0%) 0 1/160 (0.6%) 1
    Renal artery stenosis 1/318 (0.3%) 1 0/160 (0%) 0
    Renal failure 6/318 (1.9%) 7 2/160 (1.3%) 2
    Renal failure acute 8/318 (2.5%) 9 6/160 (3.8%) 6
    Renal impairment 1/318 (0.3%) 1 0/160 (0%) 0
    Urinary retention 0/318 (0%) 0 1/160 (0.6%) 1
    Reproductive system and breast disorders
    Rectocele 1/318 (0.3%) 1 0/160 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 1/318 (0.3%) 1 0/160 (0%) 0
    Acute respiratory failure 1/318 (0.3%) 2 0/160 (0%) 0
    Chronic obstructive pulmonary disease 5/318 (1.6%) 7 6/160 (3.8%) 11
    Epistaxis 0/318 (0%) 0 1/160 (0.6%) 1
    Haemoptysis 1/318 (0.3%) 1 0/160 (0%) 0
    Interstitial lung disease 0/318 (0%) 0 1/160 (0.6%) 1
    Lung infiltration 0/318 (0%) 0 1/160 (0.6%) 1
    Pleural effusion 0/318 (0%) 0 1/160 (0.6%) 1
    Pneumonia aspiration 0/318 (0%) 0 1/160 (0.6%) 1
    Pneumothorax 1/318 (0.3%) 1 0/160 (0%) 0
    Pulmonary arterial hypertension 1/318 (0.3%) 1 0/160 (0%) 0
    Pulmonary embolism 2/318 (0.6%) 2 2/160 (1.3%) 2
    Pulmonary fibrosis 1/318 (0.3%) 1 0/160 (0%) 0
    Pulmonary oedema 2/318 (0.6%) 2 0/160 (0%) 0
    Respiratory distress 1/318 (0.3%) 1 0/160 (0%) 0
    Respiratory failure 2/318 (0.6%) 2 0/160 (0%) 0
    Skin and subcutaneous tissue disorders
    Angioedema 1/318 (0.3%) 1 0/160 (0%) 0
    Surgical and medical procedures
    Bladder neoplasm surgery 0/318 (0%) 0 1/160 (0.6%) 1
    Heart transplant 3/318 (0.9%) 3 0/160 (0%) 0
    Vascular disorders
    Aortic aneurysm 1/318 (0.3%) 1 1/160 (0.6%) 1
    Aortic stenosis 1/318 (0.3%) 1 1/160 (0.6%) 1
    Arterial occlusive disease 0/318 (0%) 0 1/160 (0.6%) 1
    Arterial stenosis 1/318 (0.3%) 1 0/160 (0%) 0
    Deep vein thrombosis 3/318 (0.9%) 3 0/160 (0%) 0
    Embolism 0/318 (0%) 0 1/160 (0.6%) 1
    Haematoma 0/318 (0%) 0 1/160 (0.6%) 1
    Hypertension 1/318 (0.3%) 1 0/160 (0%) 0
    Hypertensive crisis 1/318 (0.3%) 1 0/160 (0%) 0
    Hypertensive emergency 1/318 (0.3%) 1 0/160 (0%) 0
    Hypotension 3/318 (0.9%) 3 2/160 (1.3%) 2
    Intermittent claudication 1/318 (0.3%) 1 0/160 (0%) 0
    Orthostatic hypotension 4/318 (1.3%) 4 0/160 (0%) 0
    Peripheral vascular disorder 2/318 (0.6%) 2 0/160 (0%) 0
    Thrombophlebitis superficial 1/318 (0.3%) 1 0/160 (0%) 0
    Thrombosis 1/318 (0.3%) 1 0/160 (0%) 0
    Vena cava thrombosis 0/318 (0%) 0 1/160 (0.6%) 1
    Other (Not Including Serious) Adverse Events
    Adaptive CRT (aCRT) Pacing Standard Biventricular Pacing
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 50/318 (15.7%) 34/160 (21.3%)
    Cardiac disorders
    Atrial fibrillation 10/318 (3.1%) 10 14/160 (8.8%) 15
    Cardiac failure 28/318 (8.8%) 33 14/160 (8.8%) 15
    General disorders
    Device stimulation issue 14/318 (4.4%) 17 10/160 (6.3%) 14

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and Participating Institutions will provide any publication of Study Data generated by PI and/or Participating Institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.

    Results Point of Contact

    Name/Title Adaptive CRT Clinical Research Specialist
    Organization Medtronic, Inc
    Phone 800-328-2518
    Email medtronicCRMtrials@medtronic.com
    Responsible Party:
    Medtronic Cardiac Rhythm and Heart Failure
    ClinicalTrials.gov Identifier:
    NCT00980057
    Other Study ID Numbers:
    • Adaptive CRT
    First Posted:
    Sep 18, 2009
    Last Update Posted:
    Oct 16, 2018
    Last Verified:
    Sep 1, 2018