Clinical trial NCT03305692: ECG Belt vs. Echocardiographic Optimization of CRT
Official title: Optimization of New CRT Recipients: Subjects Randomized to ECG Belt or Echocardiographic Optimization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Systolic
Keywords: cardiac resynchronization therapy
pacing
echocardiography
optimization
heart failure
Lead sponsor: Allina Health System
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2017-10-10
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Echocardiographic assessment of LV function
timeFrame: 6 months post optimization
measure: Echocardiographic assessment of LV size
timeFrame: 6 months post optimization
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: United Heart & Vascular Clinic
state: Minnesota
Study officials:
affiliation: United Heart & Vascular Clinic - Allina Health System
name: Alan Bank, MD
role: PRINCIPAL_INVESTIGATOR
References: