Left Bundle Area Versus Selective His Bundle Pacing

NCT04093414 | Terminated Results DMC FDA Device

• 1 other identifier: 2019-191
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

This is a voluntary research study to find out which location in the heart a pacemaker wire is the most efficient for a patient's heart and for battery life. Patients who volunteer and are eligible for the study will be randomized to receive one of two positions for the wire to be screwed into, in addition to studying multiple positions in the heart during the pacemaker insertion. Enrolled patients will be in the study for 1 year. They will also have an Ultrasound of their heart performed to assess how the pacemaker wire is affecting their heart. Pacemakers are connected to the heart by wires that are screwed into the heart. The wires can be connected to the heart in different places, which can affect how well the heart beats over time. The typical position is at the tip of the heart. This position may cause the heart to beat inefficiently. Over time, this could lead to weakened heart muscle, irregular heart rhythm, and more hospitalizations. The heart has special muscle cells and fibers that carry electrical signals through and around the heart. An alternative spot to place the pacemaker wire is in an area where these special cells are grouped together (called the HIS bundle). The pacemaker wire can be connected to the heart at a location which may allow the heart to beat more efficiently when compared to putting the wire at traditional spots in the heart (called HIS bundle pacing). However, sometimes connecting the wire into the HIS bundle may cause the pacemaker battery to wear out faster. Physicians can also connect the pacemaker wired near the HIS bundle (called Left left Bundle bundle area pacing). The study physicians hope this will allow the heart to beat more efficiently without causing the battery to wear out faster. The study physicians would like to study how different wire positions change heart beat efficiency and how long the pacemaker battery lasts when the wires are placed in different locations. This study will connect the pacemaker wire at either the HIS Bundle or the left bundle area pacing, to see how effectively the heart pumps and how much battery is being used.

Conditions

Bradycardia; Sinus Node Dysfunction; Atrioventricular Block

Keywords

Pacemaker; Bundle of His; Left Bundle Branch

Outcome Measures

Primary Outcomes (1)

• Ventricular Capture Threshold, 3 Months Unipolar or Bipolar

  Ventricular capture threshold is the minimum amplitude of electrical signal from the pacemaker that consistently results in capture of the ventricular myocardium (normal contraction of the ventricle after electrical depolarization) with a 1.0 millisecond pulse width setting in unipolar or Bipolar output modes, measured in volts. During pacemaker placement, the ideal ventricular capture threshold is determined by delivering a series of pulses starting at 0.75 volts and increasing by 0.125 V with each trial until consistent ventricular contraction is achieved. Pacemaker settings are programmed using the ventricular capture threshold, adjusted to include a safety margin, and may be re-adjusted over time if clinically necessary. The measurement is automatically recorded within the pacemaker and will be interrogated from the pacemaker device at 3 months post implantation.

  3 months

Secondary Outcomes (21)

• Left Ventricular Ejection Fraction (LVEF) - Intrinsic Conduction

  at index procedure prior to lead fixation

• Stroke Volume - Intrinsic Conduction

  at index procedure prior to lead fixation

• Mechanical Dyssynchrony of Anterior Left Ventricle Myocardial Wall- Intrinsic Conduction

  at index procedure prior to lead fixation

• Mechanical Dyssynchrony of Inferior Left Ventricle Myocardial Wall- Intrinsic Conduction

  at index procedure prior to lead fixation

• Mechanical Dyssynchrony of Inferior-septal Left Ventricle Myocardial Wall- Intrinsic Conduction

  at index procedure prior to lead fixation

Study Arms (2)

Selective or Non selective His Bundle Pacing

ACTIVE COMPARATOR

Pacemaker wires placed in Bundle of His

Device: Select Secure pacing lead

Left Bundle Area Pacing

ACTIVE COMPARATOR

Pacemaker wires placed in Left Bundle Branch area

Device: Select Secure pacing lead

Interventions

Select Secure pacing lead DEVICE

A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization

Also known as: Select Secure 3830, 69 cm, Medtronic Inc.

Left Bundle Area Pacing; Selective or Non selective His Bundle Pacing

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old.
• With signed consent.
• Pacemaker indication according to 2018 American College of Cardiology/American Heart Association/Heart Rhythm Society Guideline on the Evaluation and Management of Patients with Bradycardia and Cardiac Conduction Delay. With one or both of the following:
• Symptomatic sinus node dysfunction.
• Symptomatic Atrioventricular (AV) block or high degree AV block.
• Tachy-Brady syndrome

You may not qualify if:

• Previously implanted cardiac pacing devices except transvenous temporary pacemaker.
• Patients who are eligible for appropriate cardiac resynchronization therapy(CRT) or implantable cardiovert defibrillator (ICD) implantation
• Patients with prior septal myectomy
• Patients with prior surgical or transcatheter aortic valve replacement
• Anatomy precluding implant evaluated during the screening or identified during the procedure.
• Those without ability to achieve selective His bundle pacing evaluated during the screening or identified during the procedure
• Pregnant women

Sponsors & Collaborators

• David Haines, MD: lead

Study Sites (2)

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

Beaumont Health System

Troy, Michigan, 48085, United States

Location

MeSH Terms

Conditions

Bradycardia; Sick Sinus Syndrome; Atrioventricular Block

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination leading to small numbers of subjects and ECHO data not available for any subject.

Results Point of Contact

• Title: Diedre Brunk
• Organization: Beaumont Hospitals

Diedre.Brunk@beaumont.org

248-898-5580

Study Officials

• David Haines, MD

  Beaumont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Electrophysiology and Heart Rhythm Centre

Model Details: Single center, open label, randomized, prospective

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: October 7, 2019
• Primary Completion: February 14, 2022
• Study Completion: February 22, 2022
• Last Updated: August 17, 2022
• Results First Posted: August 17, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)