NCT03008291 His Bundle Pacing in Bradycardia and Heart Failure
| NCT ID | NCT03008291 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yong-Mei Cha |
| Condition | Bradycardia |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2016-10 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2016-10 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: * Age \< 18 years * Pregnant
Frequently Asked Questions
Who can join the NCT03008291 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bradycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03008291 currently recruiting?
Yes, NCT03008291 is actively recruiting participants. Visit ClinicalTrials.gov or contact Yong-Mei Cha to inquire about joining.
Where is the NCT03008291 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT03008291 clinical trial?
NCT03008291 is sponsored by Yong-Mei Cha. The trial plans to enroll 80 participants.