Persistent Atrial FibrillationNCT03700307
Effects of Different Surgical Methods for Persistent Atrial Fibrillation Combined With the Application of Statin Drugs on Left Atrial Function
A study testing Cryoballoon ablation in people with Persistent Atrial Fibrillation, run by The Second Hospital of Hebei Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Cryoballoon ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2018to 28 Dec 2020
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- •left ventricular dysfunction
- atrial thrombosis
- valvular heart disease
- hyperthyroidism
- patients who underwent prosthetic heart valve replacement
- patients with previous history of atrial fibrillation ablation
Show all 11Show fewer
- pregnant women
- patients with existing liver and kidney disease
- malignant tumors
- hematological system diseases
- patients who underwent prosthetic heart valve replacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Cryoballoon ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon ablationProcedure or surgery
Cryoablation is performed using a single cryoballoon.In general, the cryoablation of each pulmonary vein is carried out twice.
| Study group | Role | What they receive |
|---|---|---|
| pulmonary vein isolation | Experimental | patients will receive circumferential pulmonary vein isolation using cryoballoon ablation Receives: Procedure: Cryoballoon ablation |
| pulmonary vein and left atrial roof linear isol | Experimental | patients will receive circumferential pulmonary vein and left atrial roof linear isolation using cryoballoon ablation Receives: Procedure: Cryoballoon ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left atrial function of postoperative
Transthoracic echocardiography
Measured: 1-12 month
Atrial electrical activity
Electrophysiological examination
Measured: During the operation
Secondary outcomes (10)
C-Reactive Protein
Blood samples are extracted in all patients to detected
Measured: 1-12 month
leukocyte assessed
Blood samples are extracted in all patients to detected
Measured: 1-12 month
Neutrophil assessed
Blood samples are extracted in all patients to detected
Measured: 1-12 month
Lymphocyte assessed
Blood samples are extracted in all patients to detected
Measured: 1-12 month
Neutrophil/Lymphocyte
Blood samples are extracted in all patients to detected
Measured: 1-12 month
B type natriuretic peptide assessed
Blood samples are extracted in all patients to detected
Measured: 1-12 month
Coagulation index assessed
Blood samples are extracted in all patients to detected
Measured: 1-6 month
Change of P wave
Electrocardiogram
Measured: 1-12 month
homocysteine assessed
Blood samples are extracted in all patients to detected
Measured: 1-12 month
β2-microglobulin assessed
Blood samples are extracted in all patients to detected
Measured: 1-12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start28 Aug 2018
- Primary completion28 Nov 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xieruiqin, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700307
- Sponsor's protocol ID
- XieruiqindoctorAF
- Status last verified
- Mar 2020
- First submitted
- 28 Aug 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03700307
- Acronym / sponsor ID
- XieruiqindoctorAF
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- The Second Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 28 Nov 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulmonary vein isolation | Experimental | Procedure: Cryoballoon ablationpatients will receive circumferential pulmonary vein isolation using cryoballoon ablation |
| pulmonary vein and left atrial roof linear isol | Experimental | Procedure: Cryoballoon ablationpatients will receive circumferential pulmonary vein and left atrial roof linear isolation using cryoballoon ablation |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- •left ventricular dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoballoon ablationCryoablation is performed using a single cryoballoon.In general, the cryoablation of each pulmonary vein is carried out twice. | Procedure or surgery | pulmonary vein and left atrial roof linear isol, pulmonary vein isolation |
Primary outcome
Left atrial function of postoperative
Time frame: 1-12 month
Transthoracic echocardiography
Atrial electrical activity
Time frame: During the operation
Electrophysiological examination
10 secondary outcomes
C-Reactive Protein
Time frame: 1-12 month
leukocyte assessed
Time frame: 1-12 month
Neutrophil assessed
Time frame: 1-12 month
Lymphocyte assessed
Time frame: 1-12 month
Neutrophil/Lymphocyte
Time frame: 1-12 month
B type natriuretic peptide assessed
Time frame: 1-12 month
Coagulation index assessed
Time frame: 1-6 month
Change of P wave
Time frame: 1-12 month
homocysteine assessed
Time frame: 1-12 month
β2-microglobulin assessed
Time frame: 1-12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon ablation in people with Persistent Atrial Fibrillation, run by The Second Hospital of Hebei Medical University at 1 site in China.
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 11 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: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left atrial function of postoperative (time frame: 1-12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 18 Mar 2021.