Metabolic Mapping and Cardiac Resynchronization

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    100
  • sponsor
    Yong-Mei Cha
Updated on 26 March 2022
heart failure
left bundle branch block
crt-p
cardiac resynchronization therapy

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 (LBBB).

Details
Condition Heart Failure
Treatment Cardiac resynchronization therapy pacemaker (CRT-P)
Clinical Study IdentifierNCT03420833
SponsorYong-Mei Cha
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

LVEF 36%-50%
NYHA class I-II
QRS duration of ≥130ms
Left bundle branch block (LBBB)
Patient is able to receive a transvenous pectoral CRT-P implant
Patient is able to sign informed consent
Two echocardiograms are required to confirm a stable reduced LVEF

Exclusion Criteria

Advanced comorbid conditions with life expectancy <1 year
Patient is <18 of years of age
Patient has a CRT-P, or CRT-D 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
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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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