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

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ClinicalTrials.gov Identifier: NCT00850980
Recruitment Status : Withdrawn (unable to recruit)
First Posted : February 25, 2009
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Marc Gillinov, MD, 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.

Condition or disease
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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Selective AV Nodal Vagal Stimulation For Reduction of the Ventricular Rate During Atrial Fibrillation
Actual Study Start Date : February 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The primary endpoint will be the change in ventricular rate from baseline measured at each amplitude [ Time Frame: surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850980


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

Additional Information:
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Responsible Party: Marc Gillinov, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00850980     History of Changes
Other Study ID Numbers: 08-766
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes