Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03700307 |
| Other study ID # |
XieruiqindoctorAF |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 28, 2018 |
| Est. completion date |
December 28, 2020 |
Study information
| Verified date |
March 2020 |
| Source |
The Second Hospital of Hebei Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A total of 164 patients with persistent atrial fibrillation, who are planned to undergo
treatment with cryoballoon ablation, will be randomly allocated into two groups. These
patients will receive circumferential pulmonary vein isolation, circumferential pulmonary
vein and left atrial roof linear isolation using cryoballoon ablation(allocation ratio, 1:1).
Patients in each group will be randomly allocated into the statin treatment group and
non-statin treatment group (allocation ratio, 1:1). Real-time 3D ultrasound and 2D ultrasound
examinations and measurement of left atrial function are carried out for all patients before
the operation, and at 1, 2, 3 and 4 weeks and 2, 3, 6, 9 and 12 months after the operation.
Preoperative transesophageal echocardiography will be carried out in all patients to measure
the left atrial appendage function. All ultrasound data will be stored and a professional
director from the ultrasound room will be invited for quantitative analysis. Indicators for
ultrasonography include: left atrial anterior and posterior diameter, left atrial volume,
left atrial volume index, mitral e ", E peak, A peak, velocity time integral (VTI), left
atrial ejection fraction, left atrial strain, strain rate and left atrial appendage emptying
velocity. Blood samples are extracted in all patients to detect routine blood, troponin I,
D-D dimer, oral anticoagulant monitoring and other biochemical parameters such as blood
lipids before the operation and at 1, 2, 3 and 4 weeks and 1, 2 and 3 months after the
operation. This study will clarify whether these different operation methods have different
effects on the recovery of postoperative left atrial function in patients with persistent
atrial fibrillation, and whether changes in left atrial function are related to indicators
such as inflammation, blood clotting and myocardial injury. Furthermore, this study will
investigate whether the application of statin drugs can improve postoperative left atrial
function by affecting these indicators. In addition, the operation method has been improved
targeting at the disadvantage of the greater amount of X-ray exposure during cryoballoon
ablation for persistent atrial fibrillation. Circumferential pulmonary vein isolation is
combined with left atrial roof linear isolation，and related indicators such as the success
rate of the operation, intraoperative complications, postoperative recurrence rate and the
amount of x-ray exposure are compared among two groups. At the same time, biochemical
indicators of inflammation, blood clotting and myocardial injury such as blood routine,
myocardial enzyme, troponin I and D-D dimmer are detected to analyze and determine which
indicators are related to the postoperative recurrence of atrial fibrillation, the incidence
of postoperative thrombosis and the recovery of postoperative left atrial function.
Description:
A total of 164 patients with persistent atrial fibrillation(AF), who are planned to undergo
treatment with cryoballoon ablation, will be randomly allocated into two groups.
1. Each patient randomly allocated into the circumferential pulmonary vein isolation group
receives circumferential pulmonary vein isolation using cryoballoon ablation, and no
additional isolation or ablation is performed in the extrapulmonary sites unless the
patient is diagnosed with right atrial flutter before the operation.The investigators
will carry out tricuspid isthmus ablation during the operation for patients with a
preoperative diagnosis of right atrial flutter. All patients will undergo the remodeling
of pulmonary vein-left atrium under CT before the operation to understand the structures
of the left atrium and pulmonary veins. Patients who have recurrent atrial fibrillations
within the first three months during postoperative follow-up will not be considered for
repeated the operation.
2. Each patient randomly allocated into the circumferential pulmonary vein and left atrial
linear isolation group receives circumferential pulmonary vein and left atrial roof
linear isolation using cryoballoon ablation,no additional isolation or ablation is
performed in the extra sites unless the patient is diagnosed with right atrial flutter
before the operation. The investigators will carry out tricuspid isthmus ablation during
the operation for patients with a preoperative diagnosis of right atrial flutter. All
patients will undergo the remodeling of pulmonary vein-left atrium under CT before the
operation to understand the structures of the left atrium and pulmonary veins. Patients
who have recurrent atrial fibrillations within the first three months during
postoperative follow-up will not be considered for repeated the operation. Cryoablation
is performed using a single cryoballoon. The diameter of the cryoballoon (Arctic Front
Advance™ Cardiac CryoAblation Catheter; Medtronic, Minneapolis, MN) is determined as 28
mm or 23 mm according to pulmonary venography results. After passing through the
transseptal sheath, the cryoballoon catheter enters into the left atrium and is
continuously infused with heparin saline through a 12 French(12F) oriented sheath. The
circular mapping catheter (Achieve, Medtronic) will pass through the balloon catheter
and first enter into the pulmonary vein lumen. It is placed as close as possible into
the pulmonary vein to record original pulmonary vein potentials and carry out
intraoperative real-time monitoring of the isolation of pulmonary vein potentials.
The balloon is inflated at the entrance of the pulmonary vein. The mapping confirms that
the balloon blocks the entrance of the pulmonary vein. After blocking of the entrance of
the pulmonary vein is enhanced, liquid nitrogen is injected for cryoablation, which
lasts for 240 seconds each time. Before performing right pulmonary vein ablation, a
secondary catheter is placed into the superior vena cava during the cryoablation. A
cycle length of 999 ms is taken to continuously make the right phrenic nerve pulsate. If
diaphragm movement is weakened or disappears, the cryoablation will be immediately
stopped. In general, the cryoablation of each pulmonary vein is carried out twice. If
the cryoablation is unsuccessful for twice, an additional cryoablation can be carried
out; but the number of times of pulmonary vein cryoablation should not be more than
five.The patients randomly allocated into the circumferential pulmonary vein and left
atrial linear isolation group receives circumferential pulmonary vein and left atrial
roof linear isolation using cryoballoon ablation
3. Examinations of real-time 3D ultrasound, 2D ultrasound, transesophageal echocardiography
and Doppler are carried out to measure the left atrial size and function for all
patients before the operation and at 1, 2, 3 and 4 weeks and 2, 3, 6, 9 and 12 months
after the operation (iE33 machines equipped with X3, Philips). Measurement of left
atrial anterior and posterior diameter: the left ventricular long axis next to the
sternum is taken to measure the left atrial anterior and posterior diameter in the end
systolic period of the left atrium; mitral e ": apical four-chamber view, sampling
volume locates in the site of the mitral annular septum, and early diastolic blood flow
velocity is measured; E peak: mitral valve early diastolic flow velocity; A peak: mitral
valve late diastolic flow velocity; mitral valve velocity time integral. Measurement of
left atrial ejection fraction: Five references sites are taken in the atrium, including
four reference sites located in the front, lower, lateral and septal side of the top of
the atrium, and one reference site located at the level of the mitral annulus. During
the cardiac cycle, volumes at three time points will be measured. ① LAMax means that the
left atrial volume is measured in the end systolic period before the opening and closing
of the mitral valve, ② LAMin means that the left atrial volume is measured at end
diastolic period before the closing of the mitral valve, and ③ LApreA means that the
left atrial volume is measured before the appearance of the corresponding body surface
ECG P-wave. These are obtained through the following formulas using the surface area
index and left atrial function: the left atrial ejection fraction (LAEF) = [(LAMax-
LAMin) / LAMax] × 100% - the active atrial emptying rate; the active left atrial
emptying rate (LAactive) = [(LApreA - LAmin ) / LApreA] × 100% - passive atrial emptying
rate; the passive left atrial emptying rate (LA passive) = [(LAmax - LApreA) / LAmax] ×
100% - the atrial expansion index. The left atrial strain (four chambers, two-chamber):
three reference sites are placed using Qlab software (CMQ, Philips Medical Systems). In
four-chamber view, three reference sites are respectively placed in the mitral annular
septum, the free wall of the mitral annulus and the top of the atrium. In two-chamber
view, three reference sites are respectively placed in the front wall of the atrium, the
free wall of the mitral annulus and the top of the atrium. The software will
automatically track atrial muscle movement and work out the left atrial strain and left
atrial strain rate. All patients will undergo preoperative transesophageal
echocardiography to obtain the left atrial appendage (LAA) emptying velocity.
4. Patients in the two groups of cryoballoon ablation, will be randomly allocated again
into the statin treatment group and non-statin treatment group. Patients in the statin
treatment group will orally receive 20 mg of atorvastatin per night (Pfizer) for three
days before the operation and three months after the operation. Forms are filled in for
all patients before the operation to record medical histories and related biochemical
parameters in detail (including all blood routine indicators [Neutrophil%(NE%),
Lymphocyte% (LY%), NE/LY], International Normalized Ratio (INR), enzymes, troponin,
blood lipids and D-D dimer). The above-mentioned blood biochemical parameters are
reexamined for all patients at 1, 2, 3 and 4 weeks and 1, 2 and 3 months after the
operation. In addition to the above-described echocardiographic reexamination and blood
samples, the content of the follow-up after ablation also includes symptoms,
complications, electrocardiogram and 24-hour dynamic electrocardiogram.
