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OpenTrials
Completed

NCT Number: NCT01985802

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for catheter ablation of atrial fibrillation in sinus rhythm and PR prolongation exceeding or equal to 200 ms
  • QRS duration less than 120 ms
  • Normal left ventricular ejection fraction on echocardiography.

Exclusion criteria

  • Any bundle branch block
  • Second- or third-degree AV-block
  • Congestive heart failure, cardiomyopathy, myocardial infarction or major surgical procedure.

Treatment and study plan

Pacing

Other

Other names: Additional catheter may be used to evaluate heart performance during pacing. Does not require additional IV access

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Medtronic

Registry information

Official study title

Optimal Pacing in Patients With First-degree AV-block

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 15, 2013
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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