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Selective AV Nodal Vagal Stimulation For Reduction of the Ventricular Rate During Atrial Fibrillation
This study has been withdrawn prior to recruitment.
( unable to recruit )
First Received: February 23, 2009   Last Updated: February 1, 2010   History of Changes
Sponsor: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00850980
  Purpose

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.


Condition Phase
Atrial Fibrillation
Phase II

Study Type: Observational
Study Design: Prospective
Official Title: Selective AV Nodal Vagal Stimulation For Reduction of the Ventricular Rate During Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • The primary endpoint will be the change in ventricular rate from baseline measured at each amplitude [ Time Frame: surgery ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 10
Study Start Date: February 2009
Estimated Study Completion Date: December 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850980

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Marc Gillinov, M.D. Cleveland Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Cleveland Clinic ( Dr. Marc Gillinov, M.D. )
Study ID Numbers: 08-766
Study First Received: February 23, 2009
Last Updated: February 1, 2010
ClinicalTrials.gov Identifier: NCT00850980     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010