An interventional study of Pacing in First-degree AV-block and Pacing, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-11-30.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
109 studies on the registry are indexed under Atrioventricular Block; 39 are open to participants now.
This study's planned enrollment of 20 is below the median of 120 across 78 interventional studies indexed under Atrioventricular Block.
Browse Atrioventricular Block studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
Pacing will be conducted in 3 different ways (atrial, dual chamber and His-bundle pacing) at 2 different rates (basal and 100 bpm).
Other: Pacing
Also known as: Additional catheter may be used to evaluate heart performance during pacing. Does not require additional IV access
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
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Duke University