Status:
COMPLETED
Metabolic Mapping and Cardiac Resynchronization
Lead Sponsor:
Yong-Mei Cha
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Biotronik SE & Co. KG
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to gather information on the safety and effectiveness of cardiac resynchronization therapy (CRT) in patients who have mild heart failure (HF) and left bundle branch block ...
Eligibility Criteria
Inclusion
- Left Ventricular Ejection Fraction (LVEF) 35%-50%
- New York Heart Association (NYHA) class I-II
- QRS duration of ≥120ms
- Left bundle branch block (LBBB)
- Patient is able to receive a transvenous pectoral CRT implant
- Patient is able to sign informed consent
- Two echocardiograms are required to confirm a stable reduced LVEF
- Patient is on optimal and stable medical therapy (ACE inhibitor or angiotensin II type 1 (AT1 )blocker, beta blocker, etc. over the last 6 months)
Exclusion
- Advanced comorbid conditions with life expectancy \<1 year
- Patient is \<18 of years of age
- Patient has a CRT device
- Female patients who is pregnant or not on a reliable form of birth control. Women of childbearing potential are required to have negative pregnancy test within the 7 days prior to device implant
- Unwilling or unable to return for required follow-up visits
- Patient decides study participation is cost-prohibited
Key Trial Info
Start Date :
August 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2023
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT03420833
Start Date
August 20 2018
End Date
December 19 2023
Last Update
January 23 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905