Optimization of CRT Using an ECG Vest

Optimization of Cardiac Resynchronization Therapy Using an ECG Vest

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: ECG Vest Optimization

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
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • United Heart & Vascular Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in left ventricular end-systolic volume	6 months after optimization

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine the degree to which echocardiographic measures of LV function correlate with ECG Vest measures	6 months after optimization

Collaborators and Investigators

• Sponsor: Alan J. Bank, MD
• Collaborators: Medtronic
• Investigators: Principal Investigator: Alan J Bank, MD, Medical Director of Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): August 17, 2021
• Study Completion (ACTUAL): August 17, 2021

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (ESTIMATE): March 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 767654-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO