Enhance CRT

  • STATUS
    Recruiting
Updated on 7 November 2020

Summary

Enhance CRT

Description

CRT implant strategy using the longest electrical delay for non-left bundle branch block patients (Enhance CRT). 

Details
Condition Cardiovascular system
Clinical Study IdentifierTX138741
Last Modified on7 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Eligible patients will meet all of the following
Have non-LBBB morphology (includes complete RBBB and IVCD with a QRS duration > 120ms)
Have the following indication per the 2013 updated ACCF/AHA/HRS guidelines
a) LVEF ≤ 35%, sinus rhythm, ischemic or non-ischemic cardiomyopathy, a non-
LBBB pattern with QRS duration ≥ 120 ms, and NYHA class III/ambulatory class
IV on guideline directed medical therapy (GDMT)
Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker implant with no more than 10% RV pacing
Are 18 years or older, or of legal age to give informed consent specific to state and local law
Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria

Patients will be excluded if they meet any of the following
Irreversible occlusion of venous access that will prevent placement of the CRT-ICD system either through the right or left upper extremity venous system
Undergoing left ventricular lead placement via a surgical or epicardial approach
Cardiomyopathy due solely to valvular disease that is not repaired/replaced
Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study
Left bundle branch block (LBBB): QRS width ≥ 120 ms, with predominantly negative QRS in lead V1, and upright, monophasic QRS in leads I and V6
Incomplete RBBB
IVCD with a QRS duration between 110 and 119ms
Persistent or Permanent atrial fibrillation
Pacemaker dependent
Patients who are being upgraded primarily due to RV pacing
Women who are pregnant or who plan to become pregnant during the clinical trial
Life expectancy < 1 year
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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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