Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2015-12-31
2017-10-26
Brief Summary
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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 Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
Pacing
Interventions
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Pacing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* QRS duration less than 120 ms
* Normal left ventricular ejection fraction on echocardiography.
Exclusion Criteria
* Second- or third-degree AV-block
* Congestive heart failure, cardiomyopathy, myocardial infarction or major surgical procedure.
21 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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James P Daubert, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Hospital
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00048871
Identifier Type: -
Identifier Source: org_study_id