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Pacing in First-degree AV-block

Primary Purpose

First-degree AV-block, Pacing

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pacing
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for First-degree AV-block

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pacing - Cross-over

Arm Description

Pacing will be conducted in 3 different ways (atrial, dual chamber and His-bundle pacing) at 2 different rates (basal and 100 bpm).

Outcomes

Primary Outcome Measures

Echocardiographic evidence of dyssynchrony (AV, intra- or inter-ventricular)

Secondary Outcome Measures

Full Information

First Posted
November 5, 2013
Last Updated
November 28, 2017
Sponsor
Duke University
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01985802
Brief Title
Pacing in First-degree AV-block
Official Title
Optimal Pacing in Patients With First-degree AV-block
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 26, 2017 (Actual)
Study Completion Date
October 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First-degree AV-block, Pacing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pacing - Cross-over
Arm Type
Other
Arm Description
Pacing will be conducted in 3 different ways (atrial, dual chamber and His-bundle pacing) at 2 different rates (basal and 100 bpm).
Intervention Type
Other
Intervention Name(s)
Pacing
Other Intervention Name(s)
Additional catheter may be used to evaluate heart performance during pacing. Does not require additional IV access
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James P Daubert, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Pacing in First-degree AV-block

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