Optimization of CRT Using an ECG Vest

NCT ID: NCT02699944

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2021-08-17

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ECG Vest Optimization

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Alan J. Bank, MD

OTHER

Sponsor Role: lead

Responsible Party

Alan J. Bank, MD

Medical Director of Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alan J Bank, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Director of Research

Locations

United Heart & Vascular Clinic

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

767654-1

Identifier Type: -

Identifier Source: org_study_id