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OpenTrials
Completed

NCT Number: NCT02699944

Optimization of CRT 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United Heart & Vascular Clinic

Saint Paul, Minnesota, 55102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECG Vest Optimization

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.

Primary outcomes

  1. Change in left ventricular end-systolic volume

    Time frame: 6 months after optimization

Secondary outcomes

  1. Determine the degree to which echocardiographic measures of LV function correlate with ECG Vest measures

    Time frame: 6 months after optimization

Sponsors and collaborators

Lead sponsor

Alan J. Bank, MD

Other

Collaborators

  • Medtronic

Registry information

Official study title

Optimization of Cardiac Resynchronization Therapy Using an ECG Vest

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Mar 7, 2016
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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