Lead Sponsor

Biotronik, Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and Cardiac Resynchronization Therapy with a Pacemaker (CRT-P) systems are allowed.
•Patient has an implant planned to utilize left bundle branch area pacing within 30 days of consent
•Patient is able to understand the nature of the study and provide written informed consent
•Patient is available for follow-up visits on a regular basis for the expected duration of follow-up
•Patient accepts Home Monitoring® concept
•Patient age is greater than or equal to 18 years at time of consent

•Patient meets a standard contraindication for pacemaker system implant
•Patient is currently implanted with a pacemaker or Implantable Cardioverter-Defibrillator (ICD) device
•Patient has had a previous unsuccessful attempt to place a lead in the LBB area
•Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
•Patient is expected to receive a heart transplant within 12 months
•Patient life expectancy less than 12 months
•Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
•Patient reports pregnancy at the time of enrollment
•Patient is enrolled in any other investigational cardiac clinical study during the course of the study