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ECG Belt for CRT Response

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ClinicalTrials.gov Identifier: NCT03504020
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : June 24, 2019
Sponsor:
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.

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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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03504020


Contacts
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Contact: Peter Kratz 763-526-2802 peter.r.kratz@medtronic.com

  Show 23 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Study Chair: ECG Belt for CRT Response Clinical Research Specialist Medtronic

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03504020     History of Changes
Other Study ID Numbers: ECG Belt for CRT Response
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases