AdaptResponse Clinical Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02205359|
Recruitment Status : Recruiting
First Posted : July 31, 2014
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure With Left Bundle Branch Block||Device: aCRT ON Device: aCRT OFF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||AdaptResponse Clinical Trial|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
Experimental: aCRT ON
The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise
Device: aCRT ON
CRT device with AdaptivCRT enabled
Active Comparator: aCRT OFF
Device: aCRT OFF
CRT device with AdaptivCRT disabled
- Combined endpoint of all-cause mortality and intervention for heart failure decompensation [ Time Frame: 2 years post randomization ]Intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.
- All-cause mortality [ Time Frame: 2 years post randomization ]
- Percent of patients with interventions for heart failure decompensation [ Time Frame: 2 years post randomization ]Intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.
- Clinical Composite Score [ Time Frame: 6 months post randomization ]The Clinical Composite Score 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.
- Atrial fibrillation [ Time Frame: 2 years post randomization ]Incidence of atrial fibrillation lasting >6 hours in one day
- Change in Quality of Life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline to 2 years post randomization ]The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed.
- Change in Quality of Life measured by the EQ-5D [ Time Frame: Baseline to 2 years post randomization ]The EQ-5D index score will be analyzed.
- All-cause re-admissions within 30-days after a heart failure admission [ Time Frame: 2 years post randomization ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205359
|Contact: AdaptResponse Trial Leader||medtronicCRMtrials@medtronic.com|
Show 204 Study Locations
|Study Chair:||Bruce Wilkoff, MD||The Cleveland Clinic|
|Study Director:||David Steinhaus, MD||Medtronic Cardiac Rhythm and Heart Failure|