Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block

Not Applicable

Completed

• Conditions: Heart Failure; Left Bundle-Branch Block
• Interventions: Procedure: Mapping and Pacing the His Bundle; Procedure: Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing

• Registration Number: NCT03803995
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-15
• Study Start: 2019-03-20
• Status Verified: 2024-04
• Primary Completion: 2024-04-20
• Study Completion: 2024-04-26
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mapping and Pacing the His Bundle	Mapping and Pacing the His Bundle	All patients will be in this arm. Mapping and Pacing the His Bundle will be performed.
Mapping and Pacing the His Bundle	Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing	All patients will be in this arm. Mapping and Pacing the His Bundle will be performed.

Primary Outcome Measures

Name	Time	Method
Successful HB pacing sites	At device implant procedure	Collect 3D Locations and electrogram characteristics (morphology and activation time) at the sites where His Bundle (HB) pacing is associated with left bundle recruitment and corrects electrical dyssynchrony at HB pacing implant procedure.

Secondary Outcome Measures

Name	Time	Method
Ventricular activation during HB pacing	At device implant procedure	Collect ventricular activation times during HB pacing or HB plus LV pacing as compared with intrinsic rhythm and other pacing configurations at implant procedure;
Capture threshold of HB pacing	Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit	Measure capture threshold in volts of HB pacing at implant and at follow-up visits post implant
Success rate of HB pacing	At device implant procedure	Measure success rate of HB pacing or HB plus Left ventricular (LV) pacing in the correction of electrical dyssynchrony at implant procedure;
Echocardiographic measurements of LV ejection fraction	At three-month follow-up	Collect echo measurements of LV ejection fraction at three-month follow-up visit
Echocardiographic measurements of LV end-systolic volume	At three-month follow-up	Collect echo measurements of LV end-systolic volume at three-month follow-up visit
Lead impedance of HB pacing lead	Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit	Measure lead impedance in ohms of HB pacing lead at implant and at follow-up visits post implant
Sensing amplitude of HB pacing lead	Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit	Measure sensing amplitude in millivolts of HB pacing lead at implant and at follow-up visits post implant

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States