What this study is
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).
What's being tested
- CRT-D Implantation
Intervention · PROCEDURE
Cardiac resynchronization therapy defibrillator
- CRT-P Implantation
Intervention · PROCEDURE
Cardiac resynchronization therapy pacemaker
- Dual Chamber Pacemaker Implantation
Intervention · PROCEDURE
Study details
- Sponsor
- Yong-Mei Cha
- Conditions
- Bradycardia · Heart Failure
- Enrolling
- 80 people
- Starts
- 2016-10
- Est. completion
- 2026-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- HF Group
- 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
You can't join if
- Age < 18 years
- Pregnant
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic
Rochester, Minnesota, United States
- Yong-mei Cha · Contact(507) 255-2440ycha@mayo.edu
- Brent Quam · Contact507-422-3235quam.brent@mayo.edu
- Yong-Mei Cha · Principal investigator
Recruiting
Study team
Sponsor
Yong-Mei Cha
Study ID 16-005100
Principal investigator
Yong-Mei Cha, M.D.
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.