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Change of Heart Rate Variability and Baroreflex Sensitivity After Ventral Cardiac Denervation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2004 by Far Eastern Memorial Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00190112
First received: September 12, 2005
Last updated: October 5, 2010
Last verified: December 2004
  Purpose
Atrial fibrillation (Af) is the most common morbid event after open heart surgery. Its incidence ranges from 19% to 27%, as reported by the Society of Thoracic Surgeons database. Many groups have tried to understand and treat this difficult problem and have formulated different hypotheses to explain its origin. An imbalance of the autonomic nervous system after surgical intervention has been accepted as a major determinant for this morbidity. Ventral cardiac denervation is a fast and low-risk procedure. This intervention has shown significantly reduction of the incidence and severity of Af after routine coronary artery bypass surgery. This technique could be applied both on-pump or off-pump and used as an adjunctive procedure to achieve Af prophylaxis. However, the detailed mechanism remains unclear. Theoretically, heart receives its innervation from the autonomic nervous system (ANS) via the great vessels and pericardial attachment. The propensity and distribution of ANS nerve fibers are different in location. In this study, we would like to evaluate the ANS function after ventral cardiac denervation by using heart rate variability (HRV) and baroreflex (BRS) sensitivity. 30 patients proposed to have elective off-pump coronary artery bypass surgery are enrolled. After induction of anesthesia, the depth of anesthesia is controlled by inhalation agents and monitored by bispectral index. After the major cardiac operation, ventral cardiac denervation is performed by using electrocautery. The digital signals of heart rate and blood pressure are acquired before and after the surgical procedures under the same range of bispectral index (50~60). The paired HRV and BRS are analyzed. This will provide us more information to justify the procedure.

Condition Intervention
Atrial Fibrillation
Procedure: ventral cardiac denervation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Estimated Enrollment: 30
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with normal sinus rhythm proposed to undergo coronary artery bypass surgery.

Exclusion Criteria:

  • Patients with frequent atrial arrhythmia or paroxysmal Af were excluded.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00190112

Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Study Chair: Kuan-Ming Chiu, M.D. Far Eastern Memorial Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00190112     History of Changes
Other Study ID Numbers: FEMH-E-940002 
Study First Received: September 12, 2005
Last Updated: October 5, 2010
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on December 07, 2016