AzTrials
AzTrials

Atrial FibrillationNCT00190112

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

A study testing ventral cardiac denervation in people with Atrial Fibrillation, run by Far Eastern Memorial Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Atrial Fibrillation
What is being tested?
ventral cardiac denervation
Type of treatment
Surgery or procedure
How many people
30 participants
Where
No sites listed yet
Study dates
Start not givento not given
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patients with frequent atrial arrhythmia or paroxysmal Af were excluded.

Trial locations and contacts

No sites are listed yet.

About this study

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.

Read the detailed description

Coronary artery bypass and ventral cardiac denervation:

Off-pump coronary artery bypass (OPCAB) is performed based on patient's coronary angiography. Following the completion of coronary anastomoses, ventral cardiac denervation is achieved by removing the nerves around the large vessels of the base of the heart that run from the right side of the superior vena cava and end at the level of the midportion of the anterior pulmonary artery. This was done by excising the fat pads that surround the superior vena cava, the aorta, and the anterior and right lateral aspects of the main pulmonary artery.

Hemodynamic study:

All patients underwent OPCAB have Swan-Ganz catheter in our institute. Cardiac output measurement is obtained by thermodilution method. Hemodynamic variables (systemic blood pressure, pulmonary artery pressure, central venous pressure, pulmonary capillary wedge pressure, systemic vascular resistance, and pulmonary vascular resistance, etc) are recorded during the measurement.

ECG and blood pressure monitoring system:

ECG and radial arterial blood pressure were recorded by an analog to digital converter system (National Instrument Inc.). The analog signals were digitized in a rate of 500Hz and were stored in a hard disk. The data were then analyzed by a program written with MATLAB language (version 5.2, MATHWORK Co.). QRS complexes were automatically classified and manually verified as normal sinus rhythm, arterial or ventricular premature beats, or noise by comparison of the adjacent QRS morphologic features. The N-N interval time series were then transferred to a personal computer and post-processed.

Data acquisitions:

Immediately after induction of anesthesia, the patient was intubated. Routine indwelling catheters, like CVP and SG catheter were inserted. Prior to skin incision, the depth of anesthesia was monitored by BIS system using bispectral index (60~70) and adjusted by inhalation agents. Digital ECG and BP signals were recorded for 15 min without any mechanical or pharmacological interference. After completion of surgical procedures, the data acquisition was repeated once again in the operation room under the same level of anesthesia.

Baroreflex sensitivity analysis:

The analysis of BRS was conducted by both the sequence method and the spectral (α-index) method. Sequence method: In brief, the beat-by-beat time series of systolic arterial blood pressure and ECG R-R intervals were scanned to identify sequences of over three consecutive beats in which the systolic blood pressure (SBP) and R-R intervals of the next beat changed concomitantly in increasing or decreasing sequence. Such beat-to-beat sequences were identified as baroreflex sequences. A linear regression was applied to the individual sequence and only r2 values >0.85 were accepted. The measure of each type of the integrated spontaneous BRS was obtained by averaging all accepted slopes of the same type during a 5-minute recording. Spectral (α-index) method: The α-index (α) was obtained by means of the simultaneous spectral analysis of the R-R intervals and the SBP variabilities, with the calculation being made from the square root of the ratio between the R-R intervals and the SBP variability in low frequency (LF) band (αLF, 0.04 to 0.15 Hz). The coherence between the R-R intervals and SBP was assessed by a cross-spectral analysis. The α-index was calculated only when the magnitude of squared coherence (K2) between the RR and the SBP signals exceed 0.5 in LF band.

Heart rate variability analysis:

The missing intervals of the raw N-N data were linearly interpolated and resampled at 4 Hz by the Ron-Berger method. Each 5-minute segment of N-N intervals was taken for HRV analysis. The time domain measurements of HRV included SDNN, r-MSSD. The frequency-domain measurements of HRV included LF and HF, which were calculated by Welch's averaged periodogram of the N-N intervals.

Being tested
ventral cardiac denervation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ventral cardiac denervationProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00190112
Sponsor's protocol ID
FEMH-E-940002
Status last verified
Dec 2004
First submitted
12 Sep 2005
Last updated
7 Oct 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing ventral cardiac denervation in people with Atrial Fibrillation, run by Far Eastern Memorial Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kuan-Ming Chiu, M.D. (886-2-89667000 ext. 4849, kmchius@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2010.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in