Pacing in First-degree AV-block
The purpose of this study is to explore if there is a less harmful way to pace patients with first-degree AV-block to ensure that the negative effects inferred by the pacing do not outweigh the positive effects of AV-synchrony. The main hypothesis of the study is that His-bundle pacing will offer a more physiological mode of pacing in patients with first-degree AV-block than conventional pacing.
Patients scheduled for catheter ablation of atrial fibrillation (AF) in sinus rhythm, with first degree AV-block, normal QRS duration less than 120 ms and normal left ventricular ejection fraction will be included. During the AF ablation three different pacing modes (atrial, AV-synchronous and His-bundle pacing) at two different rates (5 to10 bpm above the basal rate and at 100 bpm) will be performed and evaluated using echocardiography. After the completion of all six pacing protocols (i.e., three modes at two different rates) the experimental part of the procedure ends.
The primary end-point will be echocardiographic evidence of dyssynchrony. Secondary end-points will include left ventricular ejection fraction, left ventricular volume, mitral regurgitation, septal to posterior wall motion delay and inter-ventricular wall motion delay. Since the research study is conducted in parallel with the standard catheter ablation, we do not anticipate any additional side effects as a result of the study.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Optimal Pacing in Patients With First-degree AV-block|
- Echocardiographic evidence of dyssynchrony (AV, intra- or inter-ventricular) [ Time Frame: During each step of the pacing procedure the echocardiographic data will be recorded; over approximately 5-10 minutes ] [ Designated as safety issue: No ]
|Study Start Date:||December 2015|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Pacing - Cross-over
Pacing will be conducted in 3 different ways (atrial, dual chamber and His-bundle pacing) at 2 different rates (basal and 100 bpm).
Other Name: Additional catheter may be used to evaluate heart performance during pacing. Does not require additional IV access
Please refer to this study by its ClinicalTrials.gov identifier: NCT01985802
|United States, North Carolina|
|Duke University Hospital||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Kristen Campbell, PharmD 919-668-7893 firstname.lastname@example.org|
|Principal Investigator:||James P Daubert, MD||Duke University|