- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03700307
Effects of Different Surgical Methods for Persistent Atrial Fibrillation Combined With the Application of Statin Drugs on Left Atrial Function
Changes in Left Atrial Function After Respective Treatments of Persistent Atrial Fibrillation With Circumferential Pulmonary Vein Isolation, Circumferential Pulmonary Vein and Left Atrial Linear Isolation Using Cryoballoon Ablation and Effects of the Application of Statin Drugs
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
- 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.
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
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China
- Second Hospital of Hebei Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Persistent AF is defined as AF that persists without interruption for 7 days (electrocardiogram data or Holter), atrial fibrillation cannot be prevented in patients who orally take class I and III antiarrhythmic drugs, and patient age is <80 years.
Exclusion Criteria:
•left ventricular dysfunction
- atrial thrombosis
- valvular heart disease
- hyperthyroidism
- patients who underwent prosthetic heart valve replacement
- patients with previous history of atrial fibrillation ablation
- pregnant women
- patients with existing liver and kidney disease
- malignant tumors
- hematological system diseases
- patients who underwent prosthetic heart valve replacement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pulmonary vein isolation
patients will receive circumferential pulmonary vein isolation using cryoballoon ablation
|
Cryoablation is performed using a single cryoballoon.In general, the cryoablation of each pulmonary vein is carried out twice.
|
Experimental: pulmonary vein and left atrial roof linear isol
patients will receive circumferential pulmonary vein and left atrial roof linear isolation using cryoballoon ablation
|
Cryoablation is performed using a single cryoballoon.In general, the cryoablation of each pulmonary vein is carried out twice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Atrial electrical activity
Time Frame: During the operation
|
Electrophysiological examination
|
During the operation
|
Left atrial function of postoperative
Time Frame: 1-12 month
|
Transthoracic echocardiography
|
1-12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of P wave
Time Frame: 1-12 month
|
Electrocardiogram
|
1-12 month
|
B type natriuretic peptide assessed
Time Frame: 1-12 month
|
Blood samples are extracted in all patients to detected
|
1-12 month
|
Coagulation index assessed
Time Frame: 1-6 month
|
Blood samples are extracted in all patients to detected
|
1-6 month
|
homocysteine assessed
Time Frame: 1-12 month
|
Blood samples are extracted in all patients to detected
|
1-12 month
|
β2-microglobulin assessed
Time Frame: 1-12 month
|
Blood samples are extracted in all patients to detected
|
1-12 month
|
C-Reactive Protein
Time Frame: 1-12 month
|
Blood samples are extracted in all patients to detected
|
1-12 month
|
leukocyte assessed
Time Frame: 1-12 month
|
Blood samples are extracted in all patients to detected
|
1-12 month
|
Neutrophil assessed
Time Frame: 1-12 month
|
Blood samples are extracted in all patients to detected
|
1-12 month
|
Lymphocyte assessed
Time Frame: 1-12 month
|
Blood samples are extracted in all patients to detected
|
1-12 month
|
Neutrophil/Lymphocyte
Time Frame: 1-12 month
|
Blood samples are extracted in all patients to detected
|
1-12 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XieruiqindoctorAF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Persistent Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
University of LuebeckIHF GmbH - Institut für HerzinfarktforschungRecruitingPersistent or Long-standing Persistent Atrial FibrillationGermany
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...RecruitingPersistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationChina
-
University Medical Centre LjubljanaWithdrawnPersistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationSlovenia
-
AtriCure, Inc.CompletedPersistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationUnited States
-
Medtronic Bakken Research CenterTerminatedLongstanding Persistent Atrial FibrillationSpain, Germany, Israel, Italy
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
Medtronic Cardiac SurgeryRecruitingPersistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationUnited States
Clinical Trials on Cryoballoon ablation
-
Staten Island University HospitalUnknownPersistent Atrial FibrillationUnited States
-
Pentax MedicalCompletedEsophageal CancerUnited States
-
The Second Hospital of Hebei Medical UniversityCompletedPersistent Atrial FibrillationChina
-
Shanghai 10th People's HospitalNot yet recruiting
-
G.Gennimatas General HospitalUnknownAtrial Fibrillation | Heart Failure, SystolicGreece
-
Yuksek Ihtisas HospitalCompletedParoxysmal Atrial FibrillationTurkey
-
Pentax MedicalCompletedBarrett's EsophagusUnited States, Netherlands
-
Karan SarafUniversity of ManchesterWithdrawnParoxysmal Atrial Fibrillation | Persistent Atrial Fibrillation
-
Harald VerheijAcademisch Ziekenhuis Maastricht; Thorax Centrum TwenteCompleted
-
University Hospital, Gentofte, CopenhagenCompletedAtrial FibrillationDenmark