Persistent Atrial FibrillationNCT02968056
One Staged Hybrid Approach of Surgical/Catheter Ablation for Persistent Atrial Fibrillation
A study testing Radiofrequency ablation in people with Persistent Atrial Fibrillation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
There are 10 million atrial fibrillation (AF) patients in China, and the patients are risk of stroke, heart failure and sudden death. Persistent AF is still a refractory disease, and single catheter ablation only has a success rate around 30-50%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated atrial fibrillation, without structural heart disease.
- Persistent atrial fibrillation (Af last time > 7 days, including persistent long standing atrial fibrillation)
- Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication; symptomatic patients are those who have been aware of their AF at any time within the last 5 years before enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of these.
- Patient admitted with intent to treat by either hybrid or surgical ablation
- Consent
Who cannot join
- Previous surgical ablation of atrial fibrillation
- Concomitant other cardiac diseases which require surgery at the same procedure, such as heart valve disease, congenital heart disease, coronary disease, dilated cardiomyopathy etc.
- With other forms of severe arrhythmia
- Ejection fraction of left ventricle less than 30%
- Anteroposterior diameter of left atrial over 60mm
- Tumor, active infection, pregnancy.
Show all 12Show fewer
- Previous surgeries with left thoracotomy, or expected left pleural adhesion, such as history of tuberculosis infection, pleural effusion, pneumothorax etc.
- Hyperthyroidism
- Thrombosis within left atrial appendage
- General conditions too weak to tolerate the surgeries
- Patient's circumstance that precludes completion of follow-up and/or obtaining information from the 1-year follow-up
- Other conditions not appropriate for this study based on the investigators' judgments
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Ju Mei, MD and PhD
About this study
Official title: One Staged Hybrid Approach of Minimally Invasively Surgical/Catheter Ablation for Persistent Atrial Fibrillation: A Non-Randomized Controlled Trial
There are 10 million atrial fibrillation (AF) patients in China, and the patients are risk of stroke, heart failure and sudden death. Persistent AF is still a refractory disease, and single catheter ablation only has a success rate around 30-50%. Hybrid strategy consisting of thoracoscopic epicardial ablation and transvenous endocardial ablation seems to be an attractive procedure to improve the treatment of persistent AF. However, only a few centers reported their preliminary results, and the conclusions are controversial. The investigator previously reported a minimally invasive surgical ablation from left thoracoscope only and achieved good results. Recently, the investigator successfully explored a hybrid procedure combing this unique surgical technique and transvenous catheter ablation. Here, the investigator present a study to evaluate the efficacy and safety of this novel hybrid procedure. The hypothesis is that a hybrid approach is more efficient than surgical ablation alone in the treatment of persistent AF.
This study is a non-randomized controlled study within a single institution. Isolated persistent AF patients admitted to the cardiovascular surgery department of Shanghai Xinhua Hospital will be screened for enrollment of this study. The study will recruit 180 patients in total. Based on their own willingness, the patients will be divided into hybrid group and minimally invasive (MIS) group. The MIS group patients only have surgical ablation surgery from left thoracoscope as the investigator reported before, while the hybrid group patients will have additional transvenous catheter ablation after the surgical ablation is done during the same operation. The ratio of hybrid to MIS group is expected to be 1:1, so that each group contains 90 patients. The perioperative data is collected, and the patients will be followed for 6 months. The primary outcome is the rate of sinus rhythm at 6 months post operation. The secondary outcomes include off antiarrhythmic drug rate, perioperative complications, major cardiovascular events, stroke, left ventricular systolic function, medical expense, serum brain natriuretic peptide level and quality of life. The aim is to evaluate the efficacy and safety of this novel hybrid procedure, therefore to provide more evidence of the hybrid strategy in the treatment of persistent AF.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Radiofrequency ablation
- Keywords
- atrial fibrillation, radiofrequency 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.
Radiofrequency ablationProcedure or surgery
Radiofrequency energy is used for ablation in both arms of this study (Hybrid group and MIS group)
| Study group | Role | What they receive |
|---|---|---|
| Hybrid group | Experimental | Minimally invasive surgical radiofrequency ablation of atrial fibrillation followed by catheterized radiofrequency ablation within the same procedure Receives: Procedure: Radiofrequency ablation |
| MIS group | Active comparator | Minimally invasive surgical radiofrequency ablation of atrial fibrillation only Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinus rhythm maintenance rate
Based on ECG results from 3 months and 6 months after the surgery. Any non-sinus rhythm lasting >30 seconds captured on ECG at any time will be considered failure to maintain sinus rhythm
Measured: At 6 months after the surgery
Secondary outcomes (8)
Off any antiarrhythmic drug rate
The rate is counted at 6 months
Measured: 6 months after the surgery
Perioperative complications
Emergent thoracotomy or exploration for bleeding, renal dysfunction requiring new dialysis treatment, respiratory dysfunction requiring prolonged mechanical ventilation with tracheotomy, new pacemaker implantation, and perioperative death
Measured: Within 1 month after the surgery
Major cardiovascular events
Death, Nonfatal myocardial infarction, re-admission because of heart disease
Measured: Within 6 months after discharge
Stroke
New onset of stroke after the surgery
Measured: Within 6 months after the surgery
Left ventricular systolic function
Evaluated by ejection fraction from echocardiogram
Measured: At 6 months after the surgery
Costs of treatment in Chinese Yuan
There are 3 parts. 1. Cost during the first hospitalization; 2. Cost of all the health care from first discharge to 6 months after the surgery, including seeing clinics, medication, re-hospitalization related to atrial fibrillation/surgical complications/new onset of stroke/other atrial fibrillation related complications. 3. Total cost: the combination of the abovementioned two parts.
Measured: From surgery to 6 months after the surgery
Serum brain natriuretic peptide level
Measured: 6 months after the surgery
Quality of life
Evaluated by short form 36 questionnaire
Measured: 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Mei, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xin Zhou, MD, Study director, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968056
- Sponsor's protocol ID
- XH-16-027
- Status last verified
- Jun 2018
- First submitted
- 13 Nov 2016
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Boersma LV, Castella M, van Boven W, Berruezo A, Yilmaz A, Nadal M, Sandoval E, Calvo N, Brugada J, Kelder J, Wijffels M, Mont L. Atrial fibrillation catheter ablation versus surgical ablation treatment (FAST): a 2-center randomized clinical trial. Circulation. 2012 Jan 3;125(1):23-30. doi: 10.1161/CIRCULATIONAHA.111.074047. Epub 2011 Nov 14.
PubMed 22082673Muneretto C, Bisleri G, Bontempi L, Cheema FH, Curnis A. Successful treatment of lone persistent atrial fibrillation by means of a hybrid thoracoscopic-transcatheter approach. Innovations (Phila). 2012 Jul-Aug;7(4):254-8. doi: 10.1097/IMI.0b013e31826f0462.
PubMed 23123991Pison L, La Meir M, van Opstal J, Blaauw Y, Maessen J, Crijns HJ. Hybrid thoracoscopic surgical and transvenous catheter ablation of atrial fibrillation. J Am Coll Cardiol. 2012 Jul 3;60(1):54-61. doi: 10.1016/j.jacc.2011.12.055.
PubMed 22742400Pokushalov E, Romanov A, Elesin D, Bogachev-Prokophiev A, Losik D, Bairamova S, Karaskov A, Steinberg JS. Catheter versus surgical ablation of atrial fibrillation after a failed initial pulmonary vein isolation procedure: a randomized controlled trial. J Cardiovasc Electrophysiol. 2013 Dec;24(12):1338-43. doi: 10.1111/jce.12245. Epub 2013 Sep 9.
PubMed 24016147Cox JL. A brief overview of surgery for atrial fibrillation. Ann Cardiothorac Surg. 2014 Jan;3(1):80-8. doi: 10.3978/j.issn.2225-319X.2014.01.05.
PubMed 24516803Gelsomino S, Van Breugel HN, Pison L, Parise O, Crijns HJ, Wellens F, Maessen JG, La Meir M. Hybrid thoracoscopic and transvenous catheter ablation of atrial fibrillation. Eur J Cardiothorac Surg. 2014 Mar;45(3):401-7. doi: 10.1093/ejcts/ezt385. Epub 2013 Jul 31.
PubMed 23904136Mei J, Ma N, Ding F, Chen Y, Jiang Z, Hu F, Xiao H. Complete thoracoscopic ablation of the left atrium via the left chest for treatment of lone atrial fibrillation. J Thorac Cardiovasc Surg. 2014 Jan;147(1):242-6. doi: 10.1016/j.jtcvs.2012.10.005. Epub 2012 Nov 2.
PubMed 23122696Pragliola C, Mastroroberto P, Gaudino M, Chello M, Covino E. Staged transthoracic approach to persistent atrial fibrillation (TOP-AF): study protocol for a randomized trial. Trials. 2014 May 26;15:190. doi: 10.1186/1745-6215-15-190.
PubMed 24885377Bulava A, Mokracek A, Hanis J, Kurfirst V, Eisenberger M, Pesl L. Sequential hybrid procedure for persistent atrial fibrillation. J Am Heart Assoc. 2015 Mar 25;4(3):e001754. doi: 10.1161/JAHA.114.001754.
PubMed 25809548Wang PJ. Hybrid epicardial and endocardial ablation of atrial fibrillation: is ablation on two sides of the atrial wall better than one? J Am Heart Assoc. 2015 Mar 25;4(3):e001893. doi: 10.1161/JAHA.115.001893. No abstract available.
PubMed 25809549Beukema RJ, Adiyaman A, Smit JJ, Delnoy PP, Ramdat Misier AR, Elvan A. Catheter ablation of symptomatic postoperative atrial arrhythmias after epicardial surgical disconnection of the pulmonary veins and left atrial appendage ligation in patients with atrial fibrillation. Eur J Cardiothorac Surg. 2016 Jan;49(1):265-71. doi: 10.1093/ejcts/ezv047. Epub 2015 Feb 26.
PubMed 25721819Phan K, Phan S, Thiagalingam A, Medi C, Yan TD. Thoracoscopic surgical ablation versus catheter ablation for atrial fibrillation. Eur J Cardiothorac Surg. 2016 Apr;49(4):1044-51. doi: 10.1093/ejcts/ezv180. Epub 2015 May 23.
PubMed 26003961Richardson TD, Shoemaker MB, Whalen SP, Hoff SJ, Ellis CR. Staged versus Simultaneous Thoracoscopic Hybrid Ablation for Persistent Atrial Fibrillation Does Not Affect Time to Recurrence of Atrial Arrhythmia. J Cardiovasc Electrophysiol. 2016 Apr;27(4):428-34. doi: 10.1111/jce.12906. Epub 2016 Jan 29.
PubMed 26725742Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1. No abstract available.
PubMed 22389422
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Staged Hybrid Approach of Minimally Invasively Surgical/Catheter Ablation for Persistent Atrial Fibrillation: A Non-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02968056
- Acronym / sponsor ID
- XH-16-027
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- atrial fibrillation, radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 18 Nov 2016 (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.
There are 10 million atrial fibrillation (AF) patients in China, and the patients are risk of stroke, heart failure and sudden death. Persistent AF is still a refractory disease, and single catheter ablation only has a success rate around 30-50%. Hybrid strategy consisting of thoracoscopic epicardial ablation and transvenous endocardial ablation seems to be an attractive procedure to improve the treatment of persistent AF. However, only a few centers reported their preliminary results, and the conclusions are controversial. The investigator previously reported a minimally invasive surgical ablation from left thoracoscope only and achieved good results. Recently, the investigator successfully explored a hybrid procedure combing this unique surgical technique and transvenous catheter ablation. Here, the investigator present a study to evaluate the efficacy and safety of this novel hybrid procedure. The hypothesis is that a hybrid approach is more efficient than surgical ablation alone in the treatment of persistent AF.
This study is a non-randomized controlled study within a single institution. Isolated persistent AF patients admitted to the cardiovascular surgery department of Shanghai Xinhua Hospital will be screened for enrollment of this study. The study will recruit 180 patients in total. Based on their own willingness, the patients will be divided into hybrid group and minimally invasive (MIS) group. The MIS group patients only have surgical ablation surgery from left thoracoscope as the investigator reported before, while the hybrid group patients will have additional transvenous catheter ablation after the surgical ablation is done during the same operation. The ratio of hybrid to MIS group is expected to be 1:1, so that each group contains 90 patients. The perioperative data is collected, and the patients will be followed for 6 months. The primary outcome is the rate of sinus rhythm at 6 months post operation. The secondary outcomes include off antiarrhythmic drug rate, perioperative complications, major cardiovascular events, stroke, left ventricular systolic function, medical expense, serum brain natriuretic peptide level and quality of life. The aim is to evaluate the efficacy and safety of this novel hybrid procedure, therefore to provide more evidence of the hybrid strategy in the treatment of persistent AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid group | Experimental | Procedure: Radiofrequency ablationMinimally invasive surgical radiofrequency ablation of atrial fibrillation followed by catheterized radiofrequency ablation within the same procedure |
| MIS group | Active comparator | Procedure: Radiofrequency ablationMinimally invasive surgical radiofrequency ablation of atrial fibrillation only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Isolated atrial fibrillation, without structural heart disease.
- Persistent atrial fibrillation (Af last time > 7 days, including persistent long standing atrial fibrillation)
- Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication; symptomatic patients are those who have been aware of their AF at any time within the last 5 years before enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of these.
- Patient admitted with intent to treat by either hybrid or surgical ablation
- Consent
Key exclusion criteria (12 listed)
- Previous surgical ablation of atrial fibrillation
- Concomitant other cardiac diseases which require surgery at the same procedure, such as heart valve disease, congenital heart disease, coronary disease, dilated cardiomyopathy etc.
- With other forms of severe arrhythmia
- Ejection fraction of left ventricle less than 30%
- Anteroposterior diameter of left atrial over 60mm
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 |
|---|---|---|
| Radiofrequency ablationRadiofrequency energy is used for ablation in both arms of this study (Hybrid group and MIS group) | Procedure or surgery | Hybrid group, MIS group |
Primary outcome
Sinus rhythm maintenance rate
Time frame: At 6 months after the surgery
Based on ECG results from 3 months and 6 months after the surgery. Any non-sinus rhythm lasting >30 seconds captured on ECG at any time will be considered failure to maintain sinus rhythm
8 secondary outcomes
Off any antiarrhythmic drug rate
Time frame: 6 months after the surgery
Perioperative complications
Time frame: Within 1 month after the surgery
Major cardiovascular events
Time frame: Within 6 months after discharge
Stroke
Time frame: Within 6 months after the surgery
Left ventricular systolic function
Time frame: At 6 months after the surgery
Costs of treatment in Chinese Yuan
Time frame: From surgery to 6 months after the surgery
Serum brain natriuretic peptide level
Time frame: 6 months after the surgery
Quality of life
Time frame: 6 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Background: PubMed 22082673Boersma LV, Castella M, van Boven W, Berruezo A, Yilmaz A, Nadal M, Sandoval E, Calvo N, Brugada J, Kelder J, Wijffels M, Mont L. Atrial fibrillation catheter ablation versus surgical ablation treatment (FAST): a 2-center randomized clinical trial. Circulation. 2012 Jan 3;125(1):23-30. doi: 10.1161/CIRCULATIONAHA.111.074047. Epub 2011 Nov 14.
- Background: PubMed 23123991Muneretto C, Bisleri G, Bontempi L, Cheema FH, Curnis A. Successful treatment of lone persistent atrial fibrillation by means of a hybrid thoracoscopic-transcatheter approach. Innovations (Phila). 2012 Jul-Aug;7(4):254-8. doi: 10.1097/IMI.0b013e31826f0462.
- Background: PubMed 22742400Pison L, La Meir M, van Opstal J, Blaauw Y, Maessen J, Crijns HJ. Hybrid thoracoscopic surgical and transvenous catheter ablation of atrial fibrillation. J Am Coll Cardiol. 2012 Jul 3;60(1):54-61. doi: 10.1016/j.jacc.2011.12.055.
- Background: PubMed 24016147Pokushalov E, Romanov A, Elesin D, Bogachev-Prokophiev A, Losik D, Bairamova S, Karaskov A, Steinberg JS. Catheter versus surgical ablation of atrial fibrillation after a failed initial pulmonary vein isolation procedure: a randomized controlled trial. J Cardiovasc Electrophysiol. 2013 Dec;24(12):1338-43. doi: 10.1111/jce.12245. Epub 2013 Sep 9.
- Background: PubMed 24516803Cox JL. A brief overview of surgery for atrial fibrillation. Ann Cardiothorac Surg. 2014 Jan;3(1):80-8. doi: 10.3978/j.issn.2225-319X.2014.01.05.
- Background: PubMed 23904136Gelsomino S, Van Breugel HN, Pison L, Parise O, Crijns HJ, Wellens F, Maessen JG, La Meir M. Hybrid thoracoscopic and transvenous catheter ablation of atrial fibrillation. Eur J Cardiothorac Surg. 2014 Mar;45(3):401-7. doi: 10.1093/ejcts/ezt385. Epub 2013 Jul 31.
- Background: PubMed 23122696Mei J, Ma N, Ding F, Chen Y, Jiang Z, Hu F, Xiao H. Complete thoracoscopic ablation of the left atrium via the left chest for treatment of lone atrial fibrillation. J Thorac Cardiovasc Surg. 2014 Jan;147(1):242-6. doi: 10.1016/j.jtcvs.2012.10.005. Epub 2012 Nov 2.
- Background: PubMed 24885377Pragliola C, Mastroroberto P, Gaudino M, Chello M, Covino E. Staged transthoracic approach to persistent atrial fibrillation (TOP-AF): study protocol for a randomized trial. Trials. 2014 May 26;15:190. doi: 10.1186/1745-6215-15-190.
- Background: PubMed 25809548Bulava A, Mokracek A, Hanis J, Kurfirst V, Eisenberger M, Pesl L. Sequential hybrid procedure for persistent atrial fibrillation. J Am Heart Assoc. 2015 Mar 25;4(3):e001754. doi: 10.1161/JAHA.114.001754.
- Background: PubMed 25809549Wang PJ. Hybrid epicardial and endocardial ablation of atrial fibrillation: is ablation on two sides of the atrial wall better than one? J Am Heart Assoc. 2015 Mar 25;4(3):e001893. doi: 10.1161/JAHA.115.001893. No abstract available.
- Background: PubMed 25721819Beukema RJ, Adiyaman A, Smit JJ, Delnoy PP, Ramdat Misier AR, Elvan A. Catheter ablation of symptomatic postoperative atrial arrhythmias after epicardial surgical disconnection of the pulmonary veins and left atrial appendage ligation in patients with atrial fibrillation. Eur J Cardiothorac Surg. 2016 Jan;49(1):265-71. doi: 10.1093/ejcts/ezv047. Epub 2015 Feb 26.
- Background: PubMed 26003961Phan K, Phan S, Thiagalingam A, Medi C, Yan TD. Thoracoscopic surgical ablation versus catheter ablation for atrial fibrillation. Eur J Cardiothorac Surg. 2016 Apr;49(4):1044-51. doi: 10.1093/ejcts/ezv180. Epub 2015 May 23.
- Individual participant dataSharing planned: Undecided
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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.
Xin Zhou, MD study director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation in people with Persistent Atrial Fibrillation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 12 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 14 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ju Mei, MD and PhD (86-21-25078030, ju_mei63@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinus rhythm maintenance rate (time frame: At 6 months after the surgery). 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 NCT02968056, which also lists 14 linked publications.
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 14 Jun 2018.