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Pacing in First-degree AV-block

This study is currently recruiting participants.
Verified January 2017 by Duke University
ClinicalTrials.gov Identifier:
First Posted: November 15, 2013
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University

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.

Condition Intervention
First-degree AV-block Pacing Other: Pacing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Pacing in Patients With First-degree AV-block

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: December 2015
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Pacing
Other Name: Additional catheter may be used to evaluate heart performance during pacing. Does not require additional IV access


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985802

United States, North Carolina
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
Contact: Kristen Campbell, PharmD    919-668-7893    k.campbell@duke.edu   
Sponsors and Collaborators
Duke University
Principal Investigator: James P Daubert, MD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01985802     History of Changes
Other Study ID Numbers: Pro00048871
First Submitted: November 5, 2013
First Posted: November 15, 2013
Last Update Posted: February 2, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Atrioventricular Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes