Clinical Trial: Pacing in First-degree AV-block

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Optimal Pacing in Patients With First-degree AV-block

Brief Summary:

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.

Detailed Summary:
Sponsor: Duke University

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Duke University

Dates:
Date Received: November 5, 2013
Date Started: December 2015
Date Completion:
Last Updated: January 31, 2017
Last Verified: January 2017