Selective AV Nodal Vagal Stimulation For Reduction of the Ventricular Rate During Atrial Fibrillation
Information source: The Cleveland Clinic
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Phase: Phase 2
Status: Recruiting
Sponsored by: The Cleveland Clinic Official(s) and/or principal investigator(s):
Marc Gillinov, M.D., Principal Investigator, Affiliation: Cleveland Clinic
Overall contact:
Christina Sewell, BSN, Phone: 216-444-2200, Ext: 43270, Email: sewellc@ccf.org
Summary
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 renders the patient permanently pacemaker-dependent.
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.
Clinical Details
Official title: Selective AV Nodal Vagal Stimulation For Reduction of the Ventricular Rate During Atrial Fibrillation
Study design: Other, Prospective
Primary outcome: The primary endpoint will be the change in ventricular rate from baseline measured at each amplitude
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients undergoing open heart surgery
- Able to give Informed Consent and
- Permanent/Persistent or currently in Atrial Fibrillation
Exclusion Criteria:
- 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).
Locations and Contacts
Christina Sewell, BSN, Phone: 216-444-2200, Ext: 43270, Email: sewellc@ccf.org
Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Christina Sewell, BSN, Email: sewellc@ccf.org
A. Marc Gillinov, M.D>, Principal Investigator
Additional Information
Cleveland clinic research website
Starting date: February 2009
Last updated: August 7, 2009
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