Status:
UNKNOWN
Effects of CRT Optimization as Assessed by Cardiac MR
Lead Sponsor:
Allina Health System
Collaborating Sponsors:
Minneapolis Heart Institute Foundation
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 cardiac function and clinical outcomes among patients considered non-re...
Eligibility Criteria
Inclusion
- Currently on standard medical therapy
- CRT device in place for \> 4 months
- Non-responder (ejection fraction improvement with CRT \< 5%) or incomplete responder (ejection fraction \< 40%)
- Suboptimal electrical wavefront fusion at current CRT programming as observed on 12-lead ECG
- Left bundle branch block, interventricular conduction delay or right ventricular paced underlying QRS complex
- Age \> 18 years
Exclusion
- Decompensated heart failure
- Right bundle branch block
- Pregnancy or lactation
- History of severe allergic reactions to ECG gels, electrode adhesives, and/or cardiac magnetic resonance contrast (e.g. gadolinium)
- Implantation of pacing lead in the his bundle or left bundle branch
- Frequent ventricular ectopy as defined as \>10% premature ventricular contraction burden by either device interrogation or Holter monitor, or sustained ventricular tachycardia/ventricular fibrillation
- Uncontrolled atrial fibrillation (HR \> 100 bpm)
- Patient is enrolled in concurrent research study that would potentially confound the results of this study (noting: co-enrollment acceptable if patient is enrolled in registry study)
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04763460
Start Date
July 1 2021
End Date
April 1 2025
Last Update
September 27 2021
Active Locations (2)
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1
Minneapolis Heart Institute - Abbott Northwestern Hospital (MHI West)
Minneapolis, Minnesota, United States, 55407
2
United Heart & Vascular Clinic - Nasseff Specialty Center (MHI East)
Saint Paul, Minnesota, United States, 55102