NCT04093414: LEFTBASH

Left Bundle Area Versus Selective His Bundle Pacing

Terminated NA Results posted Last updated 17 August 2022

What this trial tests

NA trial testing Select Secure pacing lead in Bradycardia in 9 participants. Terminated before completion.

Timeline

7 October 2019

Primary endpoint
14 February 2022

22 February 2022

Quick facts

Lead sponsor	David Haines, MD
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	7 October 2019
Primary completion	14 February 2022
Estimated completion	22 February 2022
Sites	2 locations across United States

Drugs / interventions tested

• Select Secure pacing lead

Conditions studied

• Bradycardia — all drugs for Bradycardia →
• Sinus Node Dysfunction — all drugs for Sinus Node Dysfunction →
• Atrioventricular Block — all drugs for Atrioventricular Block →

Sponsor

David Haines, MD

Who can join

19 and older, any sex, with Bradycardia or Sinus Node Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ventricular Capture Threshold, 3 Months Unipolar or Bipolar Primary · 3 months

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 u

Group	Value	95% CI
Selective or Non Selective His Bundle Pacing	0.66	± 0.14
Left Bundle Area Pacing	0.65	± 0.13

QRS Duration - Intrinsic Conduction Secondary · at index procedure prior to lead fixation

Duration (time in milliseconds) of the QRS wave complex interval measured from the end of the PR interval to the end of the S wave measured on a 12-lead electrocardiogram, with intrinsic conduction (prior to implantation of the pacemaker), indicating the length of time required for the electrical depolarization of the right and left ventricles of the heart and contraction of the large ventricular muscles.

Group	Value	95% CI
Selective or Non Selective His Bundle Pacing	145	± 21.21
Left Bundle Area Pacing	124.83	± 26.63

QRS Duration After Lead Fixation Secondary · at index procedure following final lead fixation

Duration (time in milliseconds) of the QRS wave complex interval measured from the end of the PR interval to the end of the S wave measured on a 12-lead electrocardiogram, with intrinsic conduction (prior to implantation of the pacemaker), indicating the length of time required for the electrical depolarization of the right and left ventricles of the heart and contraction of the large ventricular muscles. A normal duration is between 80-100 milliseconds. A QRS duration of greater than 120 milliseconds is considered abnormal.

Group	Value	95% CI
Selective or Non Selective His Bundle Pacing	129.33	± 35.8
Left Bundle Area Pacing	129.8	± 10.83

QRS Duration- 3 Months Secondary · 3 months

Duration (time in milliseconds) of the QRS wave complex interval measured from the end of the PR interval to the end of the S wave measured on a 12-lead electrocardiogram, 3 months after final pacing lead fixation, indicating the length of time required for the electrical depolarization of the right and left ventricles of the heart and contraction of the large ventricular muscles. A normal duration is between 80-100 milliseconds. A QRS duration of greater than 120 milliseconds is considered abnormal.

Group	Value	95% CI
Selective or Non Selective His Bundle Pacing	108.67	± 19.22
Left Bundle Area Pacing	123	± 46.26

Capture Threshold - 6 Months, Unipolar or Bipolar Secondary · 6 months

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, whichever value is lower, 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

Group	Value	95% CI
Selective or Non Selective His Bundle Pacing	1.18	± 0.79
Left Bundle Area Pacing	0.93	± 0.08

Capture Threshold - 12 Months, Unipolar or Bipolar Secondary · 12 months

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, whichever value is lower, 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

Group	Value	95% CI
Selective or Non Selective His Bundle Pacing	1.31	± 0.61
Left Bundle Area Pacing	1.12	± 0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.