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Trial record 3 of 13 for:    Medtronic Vectors

ECG Belt for CRT Response

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: NCT03504020
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE April 20, 2018
Last Update Posted Date April 28, 2022
Actual Study Start Date  ICMJE July 13, 2018
Actual Primary Completion Date January 7, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
Change in left ventricular end systolic volume (LVESV) from baseline to 6 months post-implant. [ Time Frame: baseline to 6 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ECG Belt for CRT Response
Official Title  ICMJE ECG Belt for CRT Response
Brief Summary The purpose of this clinical study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.
Detailed Description The ECG Belt study is a prospective, interventional, randomized, multi-center, investigational, pre-market research study. The ECG Belt Research System will be used at implant and follow-up to help implanters choose a suitable LV pacing site within the recommended locations for LV lead implantation and optimize pacing vector/timing parameters.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: ECG Belt Research System
The ECG Belt Research System is used to identify the best vector and programming parameters.
Study Arms  ICMJE
  • Experimental: ECG Belt
    The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.
    Intervention: Device: ECG Belt Research System
  • No Intervention: Control Arm
    Standard CRT through 6 months follow-up.
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2021)
498
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 20, 2022
Actual Primary Completion Date January 7, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Indicated for CRT, with QRS duration ≥130 ms, and planned to be implanted with a market-released Medtronic CRT device with AdaptivCRT and a Medtronic quadripolar LV lead.
  • Meets at least one of the following criteria: QRS duration < 150 ms, Prior documented Myocardial Infarction, Non-LBBB
  • LVEDD ≥ 55 mm, as determined by site

Exclusion Criteria:

  • Permanent/persistent AF or presenting with AF
  • Pre-existing or previous LV lead or other confounding devices e.g. Left Ventricular Assist Device, Vagal Nerve Stimulator
  • Currently implanted with IPG or ICD with > 10% RV pacing
  • Permanent complete AV block
  • Enrolled in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
  • Less than 1 year life expectancy
  • Vulnerable adults
  • Younger than 18 years of age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Italy,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03504020
Other Study ID Numbers  ICMJE ECG Belt for CRT Response
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE Medtronic Cardiac Rhythm and Heart Failure
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: ECG Belt for CRT Response Clinical Research Specialist Medtronic
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP