Inclusion Criteria:

• Adults with bradycardia indicated for pacemaker implant or heart failure patients indicated for cardiac resynchronization therapy (CRT) with one of the following:
  • Bradycardia with ventricular synchrony and QRS duration < 110 ms in men or < 100 ms in women or;
  • Bradycardia with LBBB and QRS duration ≥ 140 ms in men or  ≥ 130 ms in women or;
  • Bradycardia with RBBB and QRS duration ≥ 130 ms in men or ≥ 120 ms in women or;
  • Heart failure with LBBB and QRS duration ≥ 140 ms in men or ≥ 130 ms in women 
• Understands the nature of the study and is willing to comply with all study requirements.
• Provides written informed consent.
• For participants in Europe, females of child-bearing potential must have a negative pregnancy test prior to the procedure.

Exclusion Criteria:

• Complete AV block (3rd-degree AV block) without a stable escape rhythm or other circumstances where there is no measurable QRS.
• Subjects with a previous or current pacemaker or ICD implant.
• Anatomical or other conditions that may make a 12-lead ECG difficult to obtain, such as an allergy to components of the ECG pads, burns, open wounds, etc.
• Currently enrolled in another investigational device or drug trial that has not completed the active treatment phase and/or would conflict with this study.
• Other co-morbid condition(s) that could limit the participant’s ability to participate in the study or to comply with study requirements or impact the scientific integrity of the study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/11/2024. Questions regarding updates should be directed to the study team contact.