Optimization of CRT Using an ECG Vest
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ECG Vest Optimization
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure
Eligibility 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
Sites / Locations
- United Heart & Vascular Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CRT sub-optimal responder
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in left ventricular end-systolic volume
Secondary Outcome Measures
Determine the degree to which echocardiographic measures of LV function correlate with ECG Vest measures
Full Information
NCT ID
NCT02699944
First Posted
February 24, 2016
Last Updated
September 21, 2021
Sponsor
Alan J. Bank, MD
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT02699944
Brief Title
Optimization of CRT Using an ECG Vest
Official Title
Optimization of Cardiac Resynchronization Therapy Using an ECG Vest
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
August 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alan J. Bank, MD
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRT sub-optimal responder
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ECG Vest Optimization
Intervention Description
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 Measure Information:
Title
Change in left ventricular end-systolic volume
Time Frame
6 months after optimization
Secondary Outcome Measure Information:
Title
Determine the degree to which echocardiographic measures of LV function correlate with ECG Vest measures
Time Frame
6 months after optimization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan J Bank, MD
Organizational Affiliation
Medical Director of Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
United Heart & Vascular Clinic
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimization of CRT Using an ECG Vest
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