Change of Heart Rate Variability and Baroreflex Sensitivity After Ventral Cardiac Denervation
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedOctober 7, 2010
December 1, 2004
September 12, 2005
October 5, 2010
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Patients with normal sinus rhythm proposed to undergo coronary artery bypass surgery.
You may not qualify if:
- Patients with frequent atrial arrhythmia or paroxysmal Af were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kuan-Ming Chiu, M.D.
Far Eastern Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Last Updated
October 7, 2010
Record last verified: 2004-12