Status:
UNKNOWN
Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients
Lead Sponsor:
Allina Health System
Conditions:
Heart Failure, Systolic
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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 eject...
Detailed Description
This is a prospective, randomized study designed to evaluate if CRT device optimization, guided by electrocardiography, improves echocardiographic and clinical outcomes among HF patients with a CRT de...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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%
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04083690
Start Date
October 11 2019
End Date
October 1 2024
Last Update
June 9 2022
Active Locations (2)
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1
Minneapolis Heart Institute (Abbott Northwestern Hospital)
Minneapolis, Minnesota, United States, 55407
2
United Heart & Vascular Clinic
Saint Paul, Minnesota, United States, 55102