Clinical Trial: His Bundle Pacing in Bradycardia and Heart Failure
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: His Bundle Pacing in Bradycardia and Heart Failure
Brief Summary:
Participants in this study will either have heart failure (HF) and are scheduled to undergo cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy defibrillator (CRT-D) implantation, or have atrioventricular (AV) block 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) 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 Summary:
Sponsor: Yong-Mei Cha
Current Primary Outcome:
- QRS duration as measured by 12-lead ECG [ Time Frame: Baseline to 6 months ]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.
- QRS morphology as measured by 12-lead ECG [ Time Frame: Baseline to 6 months ]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).
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Mayo Clinic
Dates:
Date Received: November 2, 2016
Date Started: October 2016
Date Completion: December 2017
Last Updated: April 24, 2017
Last Verified: April 2017
