Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2016-10-31
2026-12-31
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.)
CRT-D Implantation
Cardiac resynchronization therapy defibrillator
CRT-P Implantation
Cardiac resynchronization therapy pacemaker
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.)
Dual Chamber Pacemaker Implantation
Interventions
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CRT-D Implantation
Cardiac resynchronization therapy defibrillator
CRT-P Implantation
Cardiac resynchronization therapy pacemaker
Dual Chamber Pacemaker Implantation
Eligibility Criteria
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Inclusion Criteria
* Clinically recommended to undergo PM, CRT-P, or CRT-D implantation or HIBP/LBAP (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders)
* Any QRS duration
* LVEF ≤ 50%
AV Block/Bradycardia Group
* Recommended to undergo dual chamber pacemaker implantation
* Any AV block or Sinus Bradycardia
Exclusion Criteria
* Pregnant
18 Years
ALL
No
Sponsors
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Yong-Mei Cha
OTHER
Responsible Party
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Yong-Mei Cha
M.D., Professor of Medicine
Principal Investigators
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Yong-Mei Cha, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Yong-mei Cha
Role: primary
Brent Quam
Role: backup
Other Identifiers
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16-005100
Identifier Type: -
Identifier Source: org_study_id