Clinical trial NCT03803995: Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block
Official title: Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Left Bundle-Branch Block
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-01-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and activation time of local intracardiac electrogram (IEGM) with an electro-anatomical mapping system during a device implant procedure and secondarily to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of electrical dyssynchrony in heart failure patients with left bundle branch block.


Eligibility criteria: Inclusion Criteria:

1. Patients are undergoing implant of an Abbott pacemaker or CRT device under standard indications
2. An ECG with a wide QRS complex (\>130 ms)
3. ECG morphology of typical complete LBBB,
4. Patients have heart failure with NYHA Class II-IV symptoms,
5. LV EF \<50%
6. At least 18 years old and not pregnant.
7. Must provide written informed consent prior to any clinical investigation related procedure.
8. Willing to comply with study evaluation requirements
9. Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days prior to the implant procedure per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.)

Exclusion Criteria:

1. Patients have non-specific intraventricular conduction delay or right bundle branch block
2. Previously implanted cardiac devices with three or more permanent leads
3. History of aortic valve repair or replacement
4. History of tricuspid valve replacement
5. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
6. Recent (\< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacemaker or CRT implant in the opinion of the investigator
7. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Primary outcomes:
measure: Successful HB pacing sites
timeFrame: At device implant procedure
Secondary outcomes:
measure: Success rate of HB pacing
timeFrame: At device implant procedure
measure: Ventricular activation during HB pacing
timeFrame: At device implant procedure
measure: Echocardiographic measurements of LV ejection fraction
timeFrame: At three-month follow-up
measure: Echocardiographic measurements of LV end-systolic volume
timeFrame: At three-month follow-up
measure: Capture threshold of HB pacing
timeFrame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
measure: Lead impedance of HB pacing lead
timeFrame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
measure: Sensing amplitude of HB pacing lead
timeFrame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
References: