Trial Outcomes & Findings for Left Bundle Area Versus Selective His Bundle Pacing (NCT NCT04093414)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

3 months

Results posted on

2022-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	Selective or Non Selective His Bundle Pacing Pacemaker wires placed in Bundle of His Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization	Left Bundle Area Pacing Pacemaker wires placed in Left Bundle Branch area Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization
3 Month Follow up STARTED	3	6
3 Month Follow up COMPLETED	3	5
3 Month Follow up NOT COMPLETED	0	1
6month Follow up STARTED	3	5
6month Follow up COMPLETED	2	2
6month Follow up NOT COMPLETED	1	3
12 Month Follow up STARTED	2	2
12 Month Follow up COMPLETED	2	2
12 Month Follow up NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Selective or Non Selective His Bundle Pacing Pacemaker wires placed in Bundle of His Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization	Left Bundle Area Pacing Pacemaker wires placed in Left Bundle Branch area Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization
3 Month Follow up Physician Decision	0	1
6month Follow up Physician Decision	1	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Selective or Non Selective His Bundle Pacing n=3 Participants Pacemaker wires placed in Bundle of His Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization	Left Bundle Area Pacing n=6 Participants Pacemaker wires placed in Left Bundle Branch area Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization	Total n=9 Participants Total of all reporting groups
Age, Continuous	80.67 years STANDARD_DEVIATION 9.02 • n=3 Participants	78.83 years STANDARD_DEVIATION 9.7 • n=6 Participants	79.44 years STANDARD_DEVIATION 8.95 • n=9 Participants
Sex: Female, Male Female	1 Participants n=3 Participants	2 Participants n=6 Participants	3 Participants n=9 Participants
Sex: Female, Male Male	2 Participants n=3 Participants	4 Participants n=6 Participants	6 Participants n=9 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	3 participants n=3 Participants	6 participants n=6 Participants	9 participants n=9 Participants

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Selective or Non Selective His Bundle Pacing n=3 Participants Pacemaker wires placed in Bundle of His Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization	Left Bundle Area Pacing n=5 Participants Pacemaker wires placed in Left Bundle Branch area Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization
Ventricular Capture Threshold, 3 Months Unipolar or Bipolar	0.66 volts Standard Deviation 0.14	0.65 volts Standard Deviation 0.13

SECONDARY outcome

Timeframe: at index procedure prior to lead fixation

Population: Echocardiogram data not collected for any subject for any outcome in this study.

Percentage of blood pumped from the left ventricle of the heart at each beat with no pacing applied

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at index procedure prior to lead fixation

Population: Echocardiogram data not collected for any subject for any outcome in this study

Volume of blood in milliliters pumped from the left ventricle of the heart at each beat with no pacing applied

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at index procedure prior to lead fixation

Population: Echocardiogram data not collected for any subject for any outcome in this study

Time to peak systolic velocity of the anterior left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at index procedure prior to lead fixation

Population: Echocardiogram data not collected for any subject for any outcome in this study

Time to peak systolic velocity of the inferior left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at index procedure prior to lead fixation

Population: Echocardiogram data not collected for any subject for any outcome in this study

Time to peak systolic velocity of the inferior-septal left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at index procedure prior to lead fixation

Population: Echocardiogram data not collected for any subject for any outcome in this study

Time to peak systolic velocity of the left ventricle anterior-septal myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at index procedure prior to lead fixation

Population: Echocardiogram data not collected for any subject for any outcome in this study

Time to peak systolic velocity of the lateral left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at index procedure prior to lead fixation

Population: Echocardiogram data not collected for any subject for any outcome in this study

Time to peak systolic velocity of the inferior-lateral left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at index procedure prior to lead fixation

Population: One patient in HIS bundle pacing group had no data for this outcome.

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.

Outcome measures

Outcome measures
Measure	Selective or Non Selective His Bundle Pacing n=2 Participants Pacemaker wires placed in Bundle of His Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization	Left Bundle Area Pacing n=6 Participants Pacemaker wires placed in Left Bundle Branch area Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization
QRS Duration - Intrinsic Conduction	145 milliseconds Standard Deviation 21.21	124.83 milliseconds Standard Deviation 26.63

SECONDARY outcome

Timeframe: at index procedure following final lead fixation

Population: One patient in left bundle area pacing group had missing data for this outcome

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.

Outcome measures

Outcome measures
Measure	Selective or Non Selective His Bundle Pacing n=3 Participants Pacemaker wires placed in Bundle of His Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization	Left Bundle Area Pacing n=5 Participants Pacemaker wires placed in Left Bundle Branch area Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization
QRS Duration After Lead Fixation	129.33 millliseconds Standard Deviation 35.8	129.8 millliseconds Standard Deviation 10.83

SECONDARY outcome

Timeframe: 3 months

Population: Echocardiogram data not collected for any subject for any outcome in this study

LVEF is the percentage of blood pumped from the left ventricle of the heart with each beat. It is calculated as the fraction of chamber volume ejected in systole (stroke volume) in relation to the volume of the blood in the ventricle at the end of diastole (end-diastolic volume). Volumes are measured via ultrasound in an echocardiogram. A healthy LVEF ranges from 50-70%. LVEF less than 40% are considered low and indicate some degree of heart failure. LVEF less than 35% are considered dangerous and indicate a subject at risk for arrhythmia.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Echocardiogram data not collected for any subject for any outcome in this study

Volume of blood in milliliters pumped from the left ventricle of the heart at each beat 3 months after final pacing lead fixation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Echocardiogram data not collected for any subject for any outcome in this study

Time to peak systolic velocity of the anterior left ventricle myocardial wall in milliseconds 3 months after final pacing lead fixation, elicited by tissue Doppler

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Echocardiogram data not collected for any subject for any outcome in this study

Time to peak systolic velocity of the inferior left ventricle myocardial wall in milliseconds 3 months after final pacing lead fixation, elicited by tissue Doppler

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Echocardiogram data not collected for any subject for any outcome in this study

Time to peak systolic velocity of the left ventricle anterior-septal myocardial wall in milliseconds 3 months after final pacing lead fixation, elicited by tissue Doppler

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Echocardiogram data not collected for any subject for any outcome in this study

Time to peak systolic velocity of the left ventricle inferior-septal myocardial wall in milliseconds 3 months after final pacing lead fixation, elicited by tissue Doppler

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Echocardiogram data not collected for any subject for any outcome in this study

Time to peak systolic velocity of the lateral left ventricle myocardial wall in milliseconds 3 months after final lead fixation, elicited by tissue Doppler

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Echocardiogram data not collected for any subject for any outcome in this study

Time to peak systolic velocity of the inferior-lateral left ventricle myocardial wall in milliseconds 3 months after final lead fixation, elicited by tissue Doppler

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: 1 patient in the left bundle area pacing group had data missing for this outcome

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.

Outcome measures

Outcome measures
Measure	Selective or Non Selective His Bundle Pacing n=3 Participants Pacemaker wires placed in Bundle of His Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization	Left Bundle Area Pacing n=4 Participants Pacemaker wires placed in Left Bundle Branch area Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization
QRS Duration- 3 Months	108.67 milliseconds Standard Deviation 19.22	123 milliseconds Standard Deviation 46.26

SECONDARY outcome

Timeframe: 6 months

Population: 4 patients completed data collection for 6 month follow-up

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 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.

Outcome measures

Outcome measures
Measure	Selective or Non Selective His Bundle Pacing n=2 Participants Pacemaker wires placed in Bundle of His Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization	Left Bundle Area Pacing n=2 Participants Pacemaker wires placed in Left Bundle Branch area Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization
Capture Threshold - 6 Months, Unipolar or Bipolar	1.18 Volts Standard Deviation 0.79	0.93 Volts Standard Deviation 0.08

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Selective or Non Selective His Bundle Pacing n=2 Participants Pacemaker wires placed in Bundle of His Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization	Left Bundle Area Pacing n=2 Participants Pacemaker wires placed in Left Bundle Branch area Select Secure pacing lead: A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization
Capture Threshold - 12 Months, Unipolar or Bipolar	1.31 Volts Standard Deviation 0.61	1.12 Volts Standard Deviation 0

Adverse Events

Selective or Non Selective His Bundle Pacing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Left Bundle Area Pacing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Diedre Brunk

Beaumont Hospitals

Phone: 248-898-5580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place