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

NCT03803995 | Completed

• 1 other identifier: CRD 969
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Left Bundle-Branch Block

Outcome Measures

Primary Outcomes (1)

• Successful HB pacing sites

  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.

  At device implant procedure

Secondary Outcomes (7)

• Success rate of HB pacing

  At device implant procedure

• Ventricular activation during HB pacing

  At device implant procedure

• Echocardiographic measurements of LV ejection fraction

  At three-month follow-up

• Echocardiographic measurements of LV end-systolic volume

  At three-month follow-up

• Capture threshold of HB pacing

  Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit

Study Arms (1)

Mapping and Pacing the His Bundle

OTHER

All patients will be in this arm. Mapping and Pacing the His Bundle will be performed.

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

Interventions

Mapping and Pacing the His Bundle PROCEDURE

During the device implant procedure, 3D electro-anatomical mapping of the His Bundle region will be performed using EnSite™ Precision™ mapping system and Advisor™ HD Grid mapping catheter. This procedure might be part of the standard-of-care at the participating centers.

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 PROCEDURE

During the device implant procedure, a VisionWire coronary guidewire will also be placed into a branch of coronary sinus (CS), targeting a lateral branch. This guidewire could be used for collecting local left ventricle (LV) activation time (Q-LV) or pacing the LV. This guidewire could also be used to deliver a LV lead at physician's discretion. This procedure might be part of the standard-of-care at the participating centers.

Mapping and Pacing the His Bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are undergoing implant of an Abbott pacemaker or CRT device under standard indications
• An ECG with a wide QRS complex (\>130 ms)
• ECG morphology of typical complete LBBB,
• Patients have heart failure with NYHA Class II-IV symptoms,
• LV EF \<50%
• At least 18 years old and not pregnant.
• Must provide written informed consent prior to any clinical investigation related procedure.
• Willing to comply with study evaluation requirements
• 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.)

You may not qualify if:

• Patients have non-specific intraventricular conduction delay or right bundle branch block
• Previously implanted cardiac devices with three or more permanent leads
• History of aortic valve repair or replacement
• History of tricuspid valve replacement
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
• 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
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 15, 2019
• Study Start: March 20, 2019
• Primary Completion: April 20, 2024
• Study Completion: April 26, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (1)