HIS-Bundle Corrective Pacing in Heart Failure

What is the Purpose of this Study?

The purpose of this study is to assess the effects of pacing-cardiac resynchronization therapy to a specific area of the heart called the His bundle (HIS-CRT), compared to biventricular pacemaker cardiac resynchronization therapy (BIV-CRT) on the heart’s function, as well as on ECG and echocardiography data collected during standard-of-care visits. Patients in this study will be undergoing scheduled cardiac resynchronization therapy (CRT) as part of their routine medical care for heart failure. Participants will be randomly assigned to 1 of 2 study groups: BIV-CRT or HIS-CRT. The differences between the groups are the position of the third lead of CRT, which may be positioned in 1 of 2 places: in an area called the coronary sinus for BIV-CRT, or a different area called the His bundle, for HIS-CRT. Procedures include completing a quality-of-life questionnaire and performing a 6-minute walk test.


Eligibility

  • * Age 18 years or older (no upper age limit)
  • * Optimal medical therapy for heart failure by current guidelines
  • * Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

HIS-BUNDLE CORRECTIVE PACING IN HEART FAILURE

Study Details
Disease Type/Condition

Other

Principal Investigator
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Braunstein, Eric

Age Group

Adult

Phase

N/A

IRB Number

STUDY00003058

ClinicalTrials.gov ID

NCT05265520

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Braunstein, Eric

Age Group

Adult

Phase

N/A

IRB Number

HIS-CRT

ClinicalTrials.gov ID

NCT05265520

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org