Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-10

Study Completion Date

2026-12-31

Brief Summary

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While cardiac resynchronization therapy remains the mainstay for advanced HF, it is not always feasible due to unfavorable anatomy of coronary sinus or pacing characteristics. In such cases, left bundle branch area pacing itself or left bundle optimized cardiac resynchronization therapy could be a rescue therapy for failed or unsuccessful biventricular cardiac resynchronization therapy. However, the efficacy and safety of left bundle branch area pacing (or left bundle optimized cardiac resynchronization therapy) as rescue therapy for biventricular cardiac resynchronization therapy is largely hypothetic and lack concrete evidence still.

Therefore, there is an unmet need for the registry purposed for left bundle branch area pacing among heart failure with mid-range (or mildly reduced) ejection fraction and heart failure with reduced ejection fraction patients to investigate its efficacy and safety.

This study aims to investigate the efficacy and safety of left bundle branch area pacing in heart failure patients with ejection fraction below normal using Selectra catheters.

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Detailed Description

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Conditions

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Left Ventricular Ejection Fraction Less Then or Equal to 50percent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Prospective LBBAP-HF cohort

Patient who underwent attempted left bundle branch area pacing using Biotronik Selectra 3D sheath and stylet driven lead (Solia S60, Biotronik).

left bundle branch area pacing

Intervention Type DEVICE

left bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas.

Retrospective LBBAP-HF cohort

Patients who underwent attempted left bundle branch area pacing using Biotronik Selectra 3D and Solia S60 lead prior to prospective enrollment.

left bundle branch area pacing

Intervention Type DEVICE

left bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas.

Interventions

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left bundle branch area pacing

left bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients previously diagnosed with heart failure with mid-range(or mildly reduced) ejection fraction and heart failure with reduced ejection fraction, which was documented by an appropriate echocardiographic study (Left ventricle ejection fraction \<50%), and
* Patients with indications of cardiac pacing or cardiac resynchronization therapy

Exclusion Criteria

* Patients aged less than 19 years.
* Pregnant.
* Patients with an expected life expectancy of less than 1 year.
* Patients with a mechanical valve for the tricuspid valve.
* Patients who need atrial pacing only.
* Patients who are not capable of receiving a transvenous pacemaker for any reason.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No