Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients

Status unconfirmed · Not applicable

Conditions studied: Heart Failure, Systolic

In brief

Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. A traditional CRT device has pacing leads implanted within the right atrium (RA), the right ventricle (RV), and within a coronary vein overlying the lateral or posterior left ventricle (LV). Within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, LV systolic function and structure, as well as decreased hospitalization rates and mortality among patients with HF. Despite improvements in CRT technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. This study looks to optimize new CRT device recipients using information obtained from standard ECG machines.

Key facts

Study ID

NCT04083690

Run by

Allina Health System

People needed

120

Starts

2019-10-11

Expected to finish

2024-10-01

Last updated by the study team

2022-06-09

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients (or their legal guardian) must be willing to provide informed consent and sign a data privacy authorization (HIPAA) form
• Age greater than or equal 18 years
• Pre-CRT EF less than or equal 40%
• Patients will be receiving or have received a first-time CRT device for standard clinical indications within \~2 months of study enrollment
• Adequate echocardiographic images for LV EF and LV ESV determination
• On optimal medical therapy

You may not qualify if…

• Patients who are pregnant or may become pregnant
• Patient has a history of severe allergic reactions from ECG gel/ electrode adhesives
• Patient has a His Bundle pacing lead
• Patient has right bundle branch block (RBBB)
• Patient is enrolled in concurrent research study that would potentially confound the results of this study
• Premature ventricular contraction (PVC) burden greater than or equal to 10%

Where it is running

• Minneapolis Heart Institute (Abbott Northwestern Hospital) — Minneapolis, Minnesota, United States (enrolling)
• United Heart & Vascular Clinic — Saint Paul, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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