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Optimization of CRT Using an ECG Vest

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ClinicalTrials.gov Identifier: NCT02699944
Recruitment Status : Active, not recruiting
First Posted : March 7, 2016
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Alan J. Bank, MD, Allina Health System

Brief Summary:
Despite advancements in implant technology and various techniques of optimization, there is still around 30% non-responder rate to cardiac resynchronization therapy (CRT). This study will assess the potential benefit of a body surface mapping technology to optimize CRT devices in the chronic sub-optimal responder setting.

Condition or disease Intervention/treatment Phase
Heart Failure Device: ECG Vest Optimization Not Applicable

Detailed Description:
Cardiac resynchronization therapy (CRT) is one of the most important advances in the treatment of patients with heart failure (HF). This therapy, also known as biventricular pacing, utilizes pacemaker leads to synchronize the contraction of the walls within the left ventricle (LV) and the contraction of the left and right ventricles. Many randomized trials have conclusively demonstrated that CRT improves symptoms, LV structure and function, hospitalization rates, and survival in appropriately selected HF patients. Nonetheless, approximately 30% of CRT patients will be "non-responders" because they will not demonstrate the expected clinical and/or echocardiographic improvement following therapy. A critical component of assessing CRT efficacy during the optimization clinic will be the use of a novel method of body surface electrocardiographic mapping under development by Medtronic, called the ECG Vest. In this proposal, we describe a research study to assess the potential benefit of using the ECG Vest as part of a CRT optimization strategy on clinical and echocardiographic outcomes (heart size and function) of patients receiving standard clinical care in the UHVC CRT Optimization Clinic.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optimization of Cardiac Resynchronization Therapy Using an ECG Vest
Study Start Date : November 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: CRT sub-optimal responder
Subjects who have had CRT for at least 6 months and who have not responded as well as they could, in their cardiologists opinion. Subjects' ejection fraction are still <50% despite CRT. A ECG Vest Optimization protocol will be utilized as one aspect to determine the best CRT programming for each individual subject.
Device: ECG Vest Optimization
As part of a standard and clinically indicated CRT optimization procedure utilize an ECG Vest as one modality for collecting information to determine best device programming.




Primary Outcome Measures :
  1. Change in left ventricular end-systolic volume [ Time Frame: 6 months after optimization ]

Secondary Outcome Measures :
  1. Determine the degree to which echocardiographic measures of LV function correlate with ECG Vest measures [ Time Frame: 6 months after optimization ]


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:

  • Patients (or their legal guardian) must be willing to provide Informed Consent and a data privacy (HIPPA) authorization
  • Patient is or will be followed clinically in the UHVC CRT Optimization Clinic
  • Patient has been implanted with a CRT device for at least 6 months
  • Patient received an echocardiogram prior to CRT implant
  • Patients must be ≥ 18 years of age

Exclusion Criteria:

  • Patient's EF is currently ≥ 50%
  • Patients who are pregnant
  • Patient has unhealed / open wounds on the torso and/or has a history of severe allergic reactions from ECG gel / electrode glue

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): NCT02699944


Locations
United States, Minnesota
United Heart & Vascular Clinic
Saint Paul, Minnesota, United States, 55102
Sponsors and Collaborators
Alan J. Bank, MD
Medtronic
Investigators
Principal Investigator: Alan J Bank, MD Medical Director of Research

Responsible Party: Alan J. Bank, MD, Medical Director of Research, Allina Health System
ClinicalTrials.gov Identifier: NCT02699944     History of Changes
Other Study ID Numbers: 767654-1
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases