Pacing in First-degree AV-block

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01985802
First received: November 5, 2013
Last updated: August 7, 2014
Last verified: July 2014
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2014
Estimated Primary Completion Date: December 2014 (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: Standard catheter used during the ablation procedure will be used. The make and/or manufacturer of these is not of importance in the current study.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985802

Sponsors and Collaborators
Duke University
Medtronic
Investigators
Principal Investigator: James P Daubert, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01985802     History of Changes
Other Study ID Numbers: Pro00048871
Study First Received: November 5, 2013
Last Updated: August 7, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014