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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00850980
• Other study ID #: 08-766
• Status: Withdrawn
• Phase: N/A
• First received: February 23, 2009
• Last updated: February 9, 2017
• Start date: February 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be the change in ventricular rate from baseline measured at each amplitude		surgery

External Links

•   Cleveland clinic research website