Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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 |
Left Ventricular Ejection Fraction (LVEF) - Intrinsic Conduction |
Percentage of blood pumped from the left ventricle of the heart at each beat with no pacing applied |
at index procedure prior to lead fixation |
|
Secondary |
Stroke Volume - Intrinsic Conduction |
Volume of blood in milliliters pumped from the left ventricle of the heart at each beat with no pacing applied |
at index procedure prior to lead fixation |
|
Secondary |
Mechanical Dyssynchrony of Anterior Left Ventricle Myocardial Wall- Intrinsic Conduction |
Time to peak systolic velocity of the anterior left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler |
at index procedure prior to lead fixation |
|
Secondary |
Mechanical Dyssynchrony of Inferior Left Ventricle Myocardial Wall- Intrinsic Conduction |
Time to peak systolic velocity of the inferior left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler |
at index procedure prior to lead fixation |
|
Secondary |
Mechanical Dyssynchrony of Inferior-septal Left Ventricle Myocardial Wall- Intrinsic Conduction |
Time to peak systolic velocity of the inferior-septal left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler |
at index procedure prior to lead fixation |
|
Secondary |
Mechanical Dyssynchrony of Left Ventricle Anterior-septal Myocardial Wall- Intrinsic Conduction |
Time to peak systolic velocity of the left ventricle anterior-septal myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler |
at index procedure prior to lead fixation |
|
Secondary |
Mechanical Dyssynchrony of Lateral Left Ventricle Myocardial Wall- Intrinsic Conduction |
Time to peak systolic velocity of the lateral left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler |
at index procedure prior to lead fixation |
|
Secondary |
Mechanical Dyssynchrony of Inferior-lateral Left Ventricle Myocardial Wall- Intrinsic Conduction |
Time to peak systolic velocity of the inferior-lateral left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler |
at index procedure prior to lead fixation |
|
Secondary |
QRS Duration - Intrinsic Conduction |
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. |
at index procedure prior to lead fixation |
|
Secondary |
QRS Duration After 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. |
at index procedure following final lead fixation |
|
Secondary |
Left Ventricular Ejection Fraction (LVEF) - 3 Months |
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. |
3 months |
|
Secondary |
Stroke Volume - 3 Months |
Volume of blood in milliliters pumped from the left ventricle of the heart at each beat 3 months after final pacing lead fixation |
3 months |
|
Secondary |
Mechanical Dyssynchrony of Anterior Left Ventricle Myocardial Wall - 3 Months |
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 |
3 months |
|
Secondary |
Mechanical Dyssynchrony of Inferior Left Ventricle Myocardial Wall - 3 Months |
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 |
3 months |
|
Secondary |
Mechanical Dyssynchrony of Left Ventricle Anterior-septal Myocardial Wall - 3 Months |
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 |
3 months |
|
Secondary |
Mechanical Dyssynchrony of Left Ventricle Inferior-septal Myocardial Wall- 3 Months |
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 |
3 months |
|
Secondary |
Mechanical Dyssynchrony of Lateral Left Ventricle Myocardial Wall- 3 Months |
Time to peak systolic velocity of the lateral left ventricle myocardial wall in milliseconds 3 months after final lead fixation, elicited by tissue Doppler |
3 months |
|
Secondary |
Mechanical Dyssynchrony of Inferior-lateral Left Ventricle Myocardial Wall- 3 Months |
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 |
3 months |
|
Secondary |
QRS Duration- 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. |
3 months |
|
Secondary |
Capture Threshold - 6 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, 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. |
6 months |
|
Secondary |
Capture Threshold - 12 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, 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. |
12 months |
|