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OpenTrials
Completed

NCT Number: NCT03305692

ECG Belt vs. Echocardiographic Optimization of CRT

Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with systolic heart failure for over 15 years. Despite years of research, there is a still a 25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used to describe the act of individualizing the therapy (CRT programming) for an individual patient. This is not often performed, but when it is, echocardiography is utilized. Recent work of body surface mapping using a novel system called the ECG Belt has shown a relationship between measures of electrical dyssynchrony and acute and chronic heart pumping function. This study will compare outcomes of patients randomized to either echocardiographic or ECG Belt optimization of CRT devices.

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Key information

Conditions

Heart Failure, Systolic Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–110 year

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

This is a prospective randomized study designed to determine whether cardiac resynchronization therapy (CRT) device programming guided by the ECG Belt (Medtronic, PLC) improves echocardiographic and functional outcomes in heart failure (HF) patients. The population will include patients treated with CRT for standard indications (not implanted for the sole purposes of this study). The study will focus enrollment on patients who do not have baseline characteristics predicting the best CRT response. Therefore the study will not enroll patients having non-ischemic HF etiology, left bundle branch (LBBB) morphology, and QRSd > 150 ms or those previously RV paced.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Willing and able to provide informed consent for participation in the study
  • Age ≥18 years
  • Received a first-time CRT device for standard clinical indication (can be upgraded from non-CRT pacemaker or defibrillator if ventricular pacing < 10%)
  • Adequate echocardiographic images for EF & LVESV determination

Exclusion criteria

  • Unhealed open wounds on the torso and/or a history of documented severe allergic reactions from ECG electrode gel
  • Enrollment in a concurrent study that could confound the results of this study
  • Pregnant or could become pregnant within the 6 month follow-up period
  • Non-ischemic cardiomyopathy, LBBB morphology, and QRSd > 150 ms
  • Dysrhythmia (AF or PVCs) that will likely result in aggregate ventricular pacing < 90% over the 6 month follow-up period

Treatment and study plan

Optimization of CRT Device

Diagnostic Test

Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to.

Primary outcomes

  1. Echocardiographic assessment of LV function

    Time frame: 6 months post optimization

    Change in ejection fraction

  2. Echocardiographic assessment of LV size

    Time frame: 6 months post optimization

    Change in left ventricular end-systolic volume

Sponsors and collaborators

Lead sponsor

Alan J. Bank, MD

Other

Collaborators

  • Medtronic

Registry information

Official study title

Optimization of New CRT Recipients: Subjects Randomized to ECG Belt or Echocardiographic Optimization

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 10, 2017
Registry last updated
Sep 27, 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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