His Bundle Pacing in Bradycardia and Heart Failure | NCT03008291 | Trialant

His Bundle Pacing in Bradycardia and Heart Failure | NCT03008291 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heart Failure Group		Patients who have any QRS duration and left ventricular ejection fraction (LVEF) ≤ 50% will be enrolled in this arm. The primary care physician will have recommended either PM, CRT-D Implantation, CRT-P Implantation, HIBP or LBAP (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders) . (This is Standard of Care for this patient population; the procedures will occur even if the patient does not participate in the study.)	Procedure: CRT-D Implantation Procedure: CRT-P Implantation
Atrioventricular Block/Bradycardia Group		Patients who have developed second or third degree atrioventricular block (AV block) or bradycardia will be enrolled in this arm. The primary care physician will have recommended dual chamber pacemaker implantation. (This is Standard of Care for this patient population; the procedures will occur even if the patient does not participate in the study.)	Procedure: Dual Chamber Pacemaker Implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QRS duration as measured by 12-lead ECG	The normal duration (interval) of the QRS complex is 0.08 and 0.10 seconds (80 and 100 ms). When the duration is between 0.10 and 0.12 seconds it is intermediate or slightly prolonged. A QRS duration of greater than 0.12 seconds is considered abnormal.	Baseline to 6 months
QRS morphology as measured by 12-lead ECG	Normal QRS width is 70-100 ms (a duration of 110 ms is sometimes observed in healthy subjects). The QRS width is useful in determining the origin of each QRS complex (e.g. sinus, atrial, junctional or ventricular).	Baseline to 6 months

Contacts/Locations Module

Condition Browse Module