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

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.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint will be the change in ventricular rate from baseline measured at each amplitude	surgery

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Marc Gillinov, M.D., The Cleveland Clinic

Publications and helpful links

Helpful Links

• Cleveland clinic research website

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: February 23, 2009
• First Submitted That Met QC Criteria: February 24, 2009
• First Posted (Estimate): February 25, 2009

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 08-766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No