Clinical trial NCT00850980: Selective AV Nodal Vagal Stimulation For Reduction of the Ventricular Rate During Atrial Fibrillation
Official title: Selective AV Nodal Vagal Stimulation For Reduction of the Ventricular Rate During Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atrial Fibrillation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing open heart surgery

* Able to give Informed Consent and
* Permanent/Persistent or currently in Atrial Fibrillation 18 years or older

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 as a proof-of-concept therapy, with concomitant monitoring of the effects on the ventricular rate.

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 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.

Eligibility 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).

Primary outcomes:
measure: The primary endpoint will be the change in ventricular rate from baseline measured at each amplitude
timeFrame: surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Marc Gillinov, M.D.
role: PRINCIPAL_INVESTIGATOR
References: