Rheumatic Valve DiseasePhase 3NCT01013688
Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
A Phase 3 study testing Cardioblate® Surgical Ablation System in people with Rheumatic Valve Disease and Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control, improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatic Valve Disease, Atrial Fibrillation
- What is being tested?
- Cardioblate® Surgical Ablation System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to May 2010
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with atrial fibrillation secondary to definite rheumatic valve disease
- At least six months and no longer than 5 years of chronic atrial fibrillation
- Age >=18 years and <=70 Patients who can give informed consent themselves in writing
- No contraindication for amiodarone
- Negative pregnancy test (in women with childbearing potential)
Who cannot join
- Any one of the following exclusion criteria is sufficient to disqualify a patient from the study
- Left atrial diameter(LAD)>=70mm
- Left ventricular eject fraction(LVEF)<=30%
- Atrial thrombus
- Contraindication for anticoagulation therapy
- Less than 6 months since last episode of cerebral infarction
Show all 10Show fewer
- Emergency operation
- Patients with a malignant tumor
- Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
- Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai cardiovascular disease hospital
Beijing, 100037
Wangxin, MD, 86 10 15810210252, liuyedao21st@hotmail.com
About this study
The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control, improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure? 150 rheumatic valve patients with chronic atrial fibrillation (AF) having concomitant valve surgery were randomized to three groups: left atrial ablation group, bi-atrial ablation group, and Amiodarone group. All patients were scheduled followed up before discharge and at 3rd, 6th and 12th postoperative months. Standard 12-lead electrocardiography (ECG), 24-hour Holter and transthoracic echocardiography were used to determine the rhythm and cardiac hemodynamic status.
Read the detailed description
The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control,improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure?
150 patients with chronic AF having concomitant cardiac surgery will be enrolled. Patients will underwent bi-atrial radiofrequency,left atrial radiofrequency or no radiofrequency procedure randomly. All the patients will receipt amiodarone 200 mg/day for 12 months postoperatively.
All patients were scheduled followed before discharge and at 3rd, 6th and 12th postoperative months.The following diagnostic procedures were performed
- Standard 12-lead electrocardiography
- Holter-ECG
- Transthoracic echocardiography
- Conditions
- Rheumatic Valve Disease, Atrial Fibrillation
- Being tested
- Cardioblate® Surgical Ablation System
- Keywords
- Radiofrequency ablation, Maze, Atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardioblate® Surgical Ablation SystemProcedure or surgery
Also called radiofrequency
Using Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery
| Study group | Role | What they receive |
|---|---|---|
| left atrial RF ablation groups | Experimental | Excised the left atrial appendage Encircling the left pulmonary veins and an extension to the posterior mitral valve annulus From the left atrial appendage to the left superior pulmonary vein A connecting line between both islands of pulmonary veins From the middle of the mitral valve ablation line down towards the base of the atria ligament of Marshall Receives: Procedure: Cardioblate® Surgical Ablation System |
| Bi-atrial radiofrequency ablation group | Experimental | In the basis of left atrial group,excised the right atrial appendage; from the amputated right atrial appendage towards the inferior vena cava; from the midterm of interatrial septum to the AV groove; ablation between the superior and inferior caval cannulation sites; radiofrequency ablation for Waterston's groove Receives: Procedure: Cardioblate® Surgical Ablation System |
| Amiodarone group | No intervention | No radiofrequency ablation procedure during the valve surgery; Amiodarone 200 mg/day for 12 months after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
At 3rd, 6th and 12th month's follow-up, to evaluate the rhythm status by ECG and 24-hour Holter and cardiac hemodynamic status by transthoracic echocardiography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startMar 2008
- Primary completionMay 2009 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Investigators
- Shengshou Hu, Study director, National center for cardiovascular disease ,china
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013688
- Sponsor's protocol ID
- Wangxin
- Status last verified
- Nov 2009
- First submitted
- 11 Nov 2009
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang X, Wang X, Song Y, Hu S, Wang W. Efficiency of radiofrequency ablation for surgical treatment of chronic atrial fibrillation in rheumatic valvular disease. Int J Cardiol. 2014 Jul 1;174(3):497-502. doi: 10.1016/j.ijcard.2014.03.153. Epub 2014 Mar 29.
PubMed 24820759
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
- ClinicalTrials.gov ID
- NCT01013688
- Acronym / sponsor ID
- Wangxin
- Conditions
- Rheumatic Valve Disease, Atrial Fibrillation
- Keywords
- Radiofrequency ablation, Maze, Atrial fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Mar 2008
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 16 Nov 2009 (estimated)
- 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.
The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control, improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure? 150 rheumatic valve patients with chronic atrial fibrillation (AF) having concomitant valve surgery were randomized to three groups: left atrial ablation group, bi-atrial ablation group, and Amiodarone group. All patients were scheduled followed up before discharge and at 3rd, 6th and 12th postoperative months. Standard 12-lead electrocardiography (ECG), 24-hour Holter and transthoracic echocardiography were used to determine the rhythm and cardiac hemodynamic status.
Detailed description
The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control,improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure?
150 patients with chronic AF having concomitant cardiac surgery will be enrolled. Patients will underwent bi-atrial radiofrequency,left atrial radiofrequency or no radiofrequency procedure randomly. All the patients will receipt amiodarone 200 mg/day for 12 months postoperatively.
All patients were scheduled followed before discharge and at 3rd, 6th and 12th postoperative months.The following diagnostic procedures were performed
- Standard 12-lead electrocardiography
- Holter-ECG
- Transthoracic echocardiography
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| left atrial RF ablation groups | Experimental | Procedure: Cardioblate® Surgical Ablation SystemExcised the left atrial appendage Encircling the left pulmonary veins and an extension to the posterior mitral valve annulus From the left atrial appendage to the left superior pulmonary vein A connecting line between both islands of pulmonary veins From the middle of the mitral valve ablation line down towards the base of the atria ligament of Marshall |
| Bi-atrial radiofrequency ablation group | Experimental | Procedure: Cardioblate® Surgical Ablation SystemIn the basis of left atrial group,excised the right atrial appendage; from the amputated right atrial appendage towards the inferior vena cava; from the midterm of interatrial septum to the AV groove; ablation between the superior and inferior caval cannulation sites; radiofrequency ablation for Waterston's groove |
| Amiodarone group | No intervention | –No radiofrequency ablation procedure during the valve surgery; Amiodarone 200 mg/day for 12 months after surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with atrial fibrillation secondary to definite rheumatic valve disease
- At least six months and no longer than 5 years of chronic atrial fibrillation
- Age >=18 years and <=70 Patients who can give informed consent themselves in writing
- No contraindication for amiodarone
- Negative pregnancy test (in women with childbearing potential)
Key exclusion criteria (10 listed)
- Any one of the following exclusion criteria is sufficient to disqualify a patient from the study
- Left atrial diameter(LAD)>=70mm
- Left ventricular eject fraction(LVEF)<=30%
- Atrial thrombus
- Contraindication for anticoagulation therapy
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 |
|---|---|---|
| Cardioblate® Surgical Ablation SystemAlso: radiofrequencyUsing Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery | Procedure or surgery | Bi-atrial radiofrequency ablation group, left atrial RF ablation groups |
Primary outcome
At 3rd, 6th and 12th month's follow-up, to evaluate the rhythm status by ECG and 24-hour Holter and cardiac hemodynamic status by transthoracic echocardiography
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
- Derived from this study: PubMed 24820759Wang X, Wang X, Song Y, Hu S, Wang W. Efficiency of radiofrequency ablation for surgical treatment of chronic atrial fibrillation in rheumatic valvular disease. Int J Cardiol. 2014 Jul 1;174(3):497-502. doi: 10.1016/j.ijcard.2014.03.153. Epub 2014 Mar 29.
Related trials for Rheumatic Valve Disease
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Recruiting
Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE
Mitral Annulus Calcification, Rheumatic Heart Disease
Not yet recruiting
Improving Management and Secondary Prevention Through Azithromycin Comparative Trial in Rheumatic Heart Disease in Nigeria)- IMPACT-RHD Nigeria
Rheumatic Fever, Valvular Heart Diseases
RecruitingPhase 1/2
Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases
Tumor, Cardiovascular Diseases
Active, not recruiting
Echocardiographic Screening of Pregnant Women During Antenatal Care
Valvular Heart Disease, Rheumatic Heart Disease
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.
Shengshou Hu study director
National center for cardiovascular disease ,china
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cardioblate® Surgical Ablation System in people with Rheumatic Valve Disease and Atrial Fibrillation, run by China National Center for Cardiovascular Diseases 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 5 inclusion and 10 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 18 Nov 2009. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 xin Wang, MD (86 10 15810210252, liuyedao21st@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At 3rd, 6th and 12th month's follow-up, to evaluate the rhythm status by ECG and 24-hour Holter and cardiac hemodynamic status by transthoracic echocardiography (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01013688, which also lists 1 linked publication.
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 Nov 2009.