Selective AV Nodal Vagal Stimulation For Reduction of the Ventricular Rate During Atrial Fibrillation
NCT ID: NCT00850980
Last Updated: 2017-02-10
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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WITHDRAWN
OBSERVATIONAL
2009-02-28
2009-12-31
Brief Summary
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Detailed Description
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In series of animal studies the investigators employed AVN-VNS delivered to the so-called AV nodal fat pad. Electrical stimulation of the fat pad resulted in release of neuromediator (acetylcholine) within the AV nodal domain. The investigators have demonstrated that this approach successfully and substantially slowed the ventricular rate during AF in both acute and chronic experiments without inflicting any damage on the AV node.
It is our hypothesis that temporary delivery of selective AVN-VNS in patients with AF will provide the benefits of reduced ventricular rate during the ongoing AF. The proposed study will be limited only to patients that are already in AF and in which open-heart surgical intervention has been scheduled. In these patients AVN-VNS will be delivered briefly (minutes) after the incision as a proof-of-concept therapy, with concomitant monitoring of the effects on the ventricular rate.
Based on the information obtained in this study, the investigators intend subsequently to test the AVN-VNS in a group of patients that develop AF post-operatively and remain in this status for several days after the surgery. A protocol for a separate study will be submitted if and when this becomes feasible.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Able to give Informed Consent and
* Permanent/Persistent or currently in Atrial Fibrillation
Exclusion Criteria
* Previous open heart surgery
* Bleeding diathesis
* Creatinine levels greater than 2.0 mg/dl
* Active Infections, i.e. endocarditis
* Implanted ICD
* Pregnancy and nursing
* Incompetence and/or other conditions, which do not allow the patient to understand the nature, significance and scope of the study
* Patients on drugs that have cholinesterase inhibitor activity (e.g., physostigmine-like substances).
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Marc Gillinov, MD
Principal Investigator
Principal Investigators
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Marc Gillinov, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Related Links
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Cleveland clinic research website
Other Identifiers
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08-766
Identifier Type: -
Identifier Source: org_study_id
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