Status:
WITHDRAWN
Selective AV Nodal Vagal Stimulation For Reduction of the Ventricular Rate During Atrial Fibrillation
Lead Sponsor:
The Cleveland Clinic
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
The study will enroll 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...
Detailed Description
Rate control during AF can be achieved by drugs (Ca++ blockers, digoxin, beta-blockers), or by AV nodal ablation. Drugs, as usual, have limitations, while the radical destruction of the AV node render...
Eligibility Criteria
Inclusion
- Patients undergoing open heart surgery
- Able to give Informed Consent and
- Permanent/Persistent or currently in Atrial Fibrillation
Exclusion
- Minimally invasive incisions
- 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).
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00850980
Start Date
February 1 2009
End Date
December 1 2009
Last Update
February 10 2017
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195