Optimization of CRT Using an ECG Vest
Optimization of Cardiac Resynchronization Therapy Using an ECG Vest
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Nov 2015
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 24, 2016
CompletedFirst Posted
Study publicly available on registry
March 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2021
CompletedSeptember 23, 2021
September 1, 2021
5.8 years
February 24, 2016
September 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in left ventricular end-systolic volume
6 months after optimization
Secondary Outcomes (1)
Determine the degree to which echocardiographic measures of LV function correlate with ECG Vest measures
6 months after optimization
Study Arms (1)
CRT sub-optimal responder
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alan J. Bank, MDlead
- Medtroniccollaborator
Study Sites (1)
United Heart & Vascular Clinic
Saint Paul, Minnesota, 55102, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan J Bank, MD
Medical Director of Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Director of Research
Study Record Dates
First Submitted
February 24, 2016
First Posted
March 7, 2016
Study Start
November 1, 2015
Primary Completion
August 17, 2021
Study Completion
August 17, 2021
Last Updated
September 23, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share