Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03504020
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : November 8, 2019
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: ECG Belt Research System Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 455 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ECG Belt for CRT Response
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: ECG Belt
The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.
Device: ECG Belt Research System
The ECG Belt Research System is used to identify the best vector and programming parameters.

No Intervention: Control Arm
Standard CRT through 6 months follow-up.

Primary Outcome Measures :
  1. Change in left ventricular end systolic volume (LVESV) from baseline to 6 months post-implant. [ Time Frame: baseline to 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03504020

Layout table for location contacts
Contact: Peter Kratz 763-526-2802

Show Show 42 study locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Layout table for investigator information
Study Chair: ECG Belt for CRT Response Clinical Research Specialist Medtronic

Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure Identifier: NCT03504020    
Other Study ID Numbers: ECG Belt for CRT Response
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases