Selective AV Nodal Vagal Stimulation For Reduction of the Ventricular Rate During Atrial Fibrillation

Withdrawn

• Conditions: Atrial Fibrillation

• Registration Number: NCT00850980
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the change in ventricular rate from baseline measured at each amplitude	surgery

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States