Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT) (BENEFIT)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00996086
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Northwestern University
VA Pittsburgh Healthcare System
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date October 14, 2009
First Posted Date October 16, 2009
Last Update Posted Date February 4, 2019
Study Start Date February 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2009)
  • Change in 6-minute hall walk distance between baseline and subsequent follow-up [ Time Frame: 12 months ]
  • Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36) [ Time Frame: 12 months ]
  • The occurrence of either death (all-cause) or first HF hospitalization. [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 15, 2009)
  • Quality of Life [ Time Frame: 12 months ]
  • Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index [ Time Frame: 12 months ]
  • Cause-specific mortality [ Time Frame: 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)
Official Title Risk Stratification and Benefits With Cardiac Resynchronization Therapy
Brief Summary This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.
Detailed Description

The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to determine in patients implanted with CRT-D if the combined use of cTnT and BNP can further predict and risk-stratify HF improvement and all-cause mortality. Additionally, novel biochemical markers defining cardiac mortality in high risk patients detected by plasma proteomic analysis in the CRT-D patients will be evaluated.

This study represents a combination of previous CRT studies that evaluated these variables independently. Data from this study will be pooled with data from previous studies to build a more complete picture of CRT therapy.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
There is a genetic substudy that will evaluate the presence of certain protein markers.
Sampling Method Non-Probability Sample
Study Population All patients who undergo implantation of a market-approved St. Jude Medical CRT defibrillator (CRT-D) and a compatible lead system may be included in the study.
Condition
  • Heart Failure
  • Ventricular Arrhythmias
Intervention Device: CRT device implant
CRT device-recipients
Study Groups/Cohorts CRT device-recipients
Intervention: Device: CRT device implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 17, 2013)
154
Original Estimated Enrollment
 (submitted: October 15, 2009)
150
Actual Study Completion Date September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Meets current clinical indications for CRT-D therapy
  • Patient is 18 years old or older
  • Ability to independently comprehend and complete all QOL questionnaires
  • Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath
  • Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up

Exclusion Criteria:

  • Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure.
  • Myocardial infarction in the last 3 weeks
  • Unstable angina in the last 3 weeks
  • Status 1 classification for cardiac transplantation
  • Currently participating in a clinical trial that includes an active treatment arm
  • Life expectancy of less than 12 months.
  • Recent (within 1 week) administration of Nesiritide™ or inotropes
  • Patients in whom revascularization is expected
  • Patient is pregnant
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00996086
Other Study ID Numbers CRD 480
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators
  • Northwestern University
  • VA Pittsburgh Healthcare System
Investigators
Principal Investigator: Alan Kadish, M.D. Northwestern University
Principal Investigator: Alaa Shalaby, M.D. VA Pittsburgh Healthcare System
PRS Account Abbott Medical Devices
Verification Date February 2019