His Bundle Pacing in Bradycardia and Heart Failure

Conditions

• Bradycardia
• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CRT-D Implantation — PROCEDURE
  Cardiac resynchronization therapy defibrillator
• CRT-P Implantation — PROCEDURE
  Cardiac resynchronization therapy pacemaker
• Dual Chamber Pacemaker Implantation — PROCEDURE

Study Details

Participants in this study will either have heart failure (HF) and are scheduled to undergo pace maker (PM) implantation, cardiac resynchronization therapy pacemaker (CRT-P), cardiac resynchronization therapy defibrillator (CRT-D) implantation, His bundle pacing (HIBP) or left bundle area pacing (LBAP) (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders), or have atrioventricular (AV) block or bradycardia and are scheduled to undergo dual chamber pacemaker implantation. In this study additional heart rhythm measurements will be collected during the implant procedure to better understand how His bundle and/or parahisian pacing (HISP) effects electrical conduction in the hearts of patients with HF or AV block. The hypothesis is that His bundle or parahisian pacing (HISP) and left bundle area pacing (LBAP) may normalize atrioventricular (AV) conduction with a narrow combination of the Q wave, R wave and S wave (QRS complex) in functional bundle branch block or conduction delay in patients with heart failure (HF).

Key Dates

Start date

Oct 31, 2016

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

80 participants (estimated)

Arms

• Arm: 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.)
• Arm: 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.)

Primary Outcome Measure

QRS duration as measured by 12-lead ECG [ Time Frame: Baseline to 6 months ]

Central Contacts

• Yong-Mei Cha, M.D.
  (507) 255-2440
  [email protected]
• Brent W Quam
  507-422-3235
  [email protected]

Locations (1)

Find similar trials in Rochester, MN

Related Studies

• Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
  Recruiting · Medtronic · Birmingham, Alabama
• The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
  Recruiting · Cardiac Dimensions, Inc. · Gilbert, Arizona
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
  Recruiting · Duke University · Phoenix, Arizona
• A Study to Evaluate Breathing Muscle Training in Cardiac Rehab
  Recruiting · Mayo Clinic · Rochester, Minnesota