Paroxysmal Atrial FibrillationNCT02838914
Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by Multimodal Echocardiographic Techniques
A study testing radiofrequency ablation (RFCA) in people with Paroxysmal Atrial Fibrillation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of the study is to assess the reconstruction and inverse reconstruction in right atrium by speckle tracking echocardiography combined with real-time three dimensional echocardiography for atrial fibrillation patients before and after radiofrequency ablation (RFCA) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- radiofrequency ablation (RFCA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With a history of paroxysmal Af (PAF) and PAF record within 6 months prior to ablation, confirming at least one of the following findings: AF lasting for ≥30 s recorded in Holter or 12-lead ECG.
- No response to more than one antiarrhythmic drug, or unwilling to receive longterm drug treatment.
- Can provide informed consent form expressing willingness to participate in the study and comply with follow-up tests and evaluation procedures.
- Aged 18-80 years.
Who cannot join
- With acute diseases, such as acute phase after myocardial infarction (within 3 months), within 3 months after acute heart failure or new cerebral infarction;
- In the list of heart transplantation;
- Expected survival less than 1 year;
- With other hemorrhagic diseases and anticoagulant therapy is not allowed;
- Thrombosis in left atrium;
- Heart failure, New York Heart Association(NYHA) III/IV or eject fraction(EF)<40%;
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- Patients with uncontrolled cancer;
- Significant hepatic or renal impairment (and/or alanine transaminase(ALT) or Aspartate transaminase(AST) >2 times upper limit of normal, creatinine clearance rate(CCr)<50%);
- Previous catheter radiofrequency ablation for AF or cardiac surgery;
- Pregnant and lactating women, women who plan to become pregnant, or women of child bearing age not using reliable contraceptive measures.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Kun Sun, M.D.;Ph.D, 13651696395, Sunkunxh@163.com
Yi Yu, M.D., 13817308128, yuyi20122012@163.com
About this study
Official title: Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by by Multimodal Echocardiographic Techniques for Atrial Fibrillation Patients Before and After Radiofrequency Ablation
The purpose of the study is to assess the reconstruction and inverse reconstruction in right atrium by speckle tracking echocardiography combined with real-time three dimensional echocardiography for atrial fibrillation patients before and after radiofrequency ablation (RFCA)
Read the detailed description
The prevalence of atrial fibrillation (AF) has increased in recent years. The construction and function of right atrium haven't shown clearly before and after radiofrequency ablation (RFCA).The purpose of the study is to investigate whether RFCA can lead to inverse reconstruction of right atrium for atrial fibrillation patients, which diagnosing by speckle tracking echocardiography combined with real-time three dimensional echocardiography. All patients will be followed up for 12 months.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- radiofrequency ablation (RFCA)
- Keywords
- Right atrium, Echocardiography, Remodeling
- 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 ablation (RFCA)Procedure or surgery
Patients undergo radiofrequency ablation (RFCA)
| Study group | Role | What they receive |
|---|---|---|
| patients with AF | Experimental | Before radiofrequency ablation (RFCA) Receives: Procedure: radiofrequency ablation (RFCA) |
| Assigned Comparisons | Experimental | After radiofrequency ablation (RFCA) Receives: Procedure: radiofrequency ablation (RFCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Measured: In one week before RFCA
Secondary outcomes (4)
Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Measured: In one week after RFCA
Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Measured: At three months after RFCA
Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Measured: At six months after RFCA
Adverse event that is related to RFCA, such as the incidence of cardiac tamponade (%) was obtained by echocardiography
Measured: In one week after RFCA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJun 2015
- Primary completionMay 2019 (estimated)
- Study completionAug 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 Paroxysmal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Yu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Kun Sun, M.D.;Ph.D., Principal investigator, Department of Ultrasound, Xinhua Hospital, Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838914
- Sponsor's protocol ID
- XH-16-006
- Status last verified
- Dec 2018
- First submitted
- 15 Apr 2016
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Thihalolipavan S, Morin DP. Atrial fibrillation and congestive heart failure. Heart Fail Clin. 2014 Apr;10(2):305-18. doi: 10.1016/j.hfc.2013.12.005. Epub 2014 Feb 4.
PubMed 24656107Extramiana F, Maison-Blanche P. Stroke and atrial fibrillation: where to go from here? Stroke. 2015 Mar;46(3):605-7. doi: 10.1161/STROKEAHA.114.007809. Epub 2015 Jan 29. No abstract available.
PubMed 25634002January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
PubMed 24685669Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available.
PubMed 20876603Rondano E, Dell'Era G, De Luca G, Piccinino C, Bellomo G, Marino PN. Left atrial asynchrony is a major predictor of 1-year recurrence of atrial fibrillation after electrical cardioversion. J Cardiovasc Med (Hagerstown). 2010 Jul;11(7):499-506. doi: 10.2459/JCM.0b013e32833757b5.
PubMed 20445461Wang Z, Tan H, Zhong M, Jiang G, Zhang Y, Zhang W. Strain rate imaging for noninvasive functional quantification of the left atrium in hypertensive patients with paroxysmal atrial fibrillation. Cardiology. 2008;109(1):15-24. doi: 10.1159/000105322. Epub 2007 Jul 10.
PubMed 17627105Lee YS, Hyun DW, Jung BC, Cho YK, Lee SH, Shin DG, Park HS, Han SW, Kim YN; KTK Cardiac Electrophysiology Working Group. Left atrial volume index as a predictor for occurrence of atrial fibrillation after ablation of typical atrial flutter. J Cardiol. 2010 Nov;56(3):348-53. doi: 10.1016/j.jjcc.2010.07.006.
PubMed 20889311Muller H, Reverdin S, Burri H, Shah D, Lerch R. Measurement of left and right atrial volume in patients undergoing ablation for atrial arrhythmias: comparison of a manual versus semiautomatic algorithm of real time 3D echocardiography. Echocardiography. 2014 Apr;31(4):499-507. doi: 10.1111/echo.12391. Epub 2013 Oct 15.
PubMed 24128369Peluso D, Badano LP, Muraru D, Dal Bianco L, Cucchini U, Kocabay G, Kovacs A, Casablanca S, Iliceto S. Right atrial size and function assessed with three-dimensional and speckle-tracking echocardiography in 200 healthy volunteers. Eur Heart J Cardiovasc Imaging. 2013 Nov;14(11):1106-14. doi: 10.1093/ehjci/jet024. Epub 2013 Feb 19.
PubMed 23423966Marwick TH, Leano RL, Brown J, Sun JP, Hoffmann R, Lysyansky P, Becker M, Thomas JD. Myocardial strain measurement with 2-dimensional speckle-tracking echocardiography: definition of normal range. JACC Cardiovasc Imaging. 2009 Jan;2(1):80-4. doi: 10.1016/j.jcmg.2007.12.007.
PubMed 19356538Reant P, Labrousse L, Lafitte S, Bordachar P, Pillois X, Tariosse L, Bonoron-Adele S, Padois P, Deville C, Roudaut R, Dos Santos P. Experimental validation of circumferential, longitudinal, and radial 2-dimensional strain during dobutamine stress echocardiography in ischemic conditions. J Am Coll Cardiol. 2008 Jan 15;51(2):149-57. doi: 10.1016/j.jacc.2007.07.088.
PubMed 18191740Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. Eur J Echocardiogr. 2011 Mar;12(3):167-205. doi: 10.1093/ejechocard/jer021.
PubMed 21385887Mirza M, Caracciolo G, Khan U, Mori N, Saha SK, Srivathsan K, Altemose G, Scott L, Sengupta P, Jahangir A. Left atrial reservoir function predicts atrial fibrillation recurrence after catheter ablation: a two-dimensional speckle strain study. J Interv Card Electrophysiol. 2011 Sep;31(3):197-206. doi: 10.1007/s10840-011-9560-6. Epub 2011 Mar 22.
PubMed 21424845Puwanant S, Park M, Popovic ZB, Tang WH, Farha S, George D, Sharp J, Puntawangkoon J, Loyd JE, Erzurum SC, Thomas JD. Ventricular geometry, strain, and rotational mechanics in pulmonary hypertension. Circulation. 2010 Jan 19;121(2):259-66. doi: 10.1161/CIRCULATIONAHA.108.844340. Epub 2010 Jan 4.
PubMed 20048214
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by by Multimodal Echocardiographic Techniques for Atrial Fibrillation Patients Before and After Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT02838914
- Acronym / sponsor ID
- XH-16-006
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Right atrium, Echocardiography, Remodeling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 20 Jul 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.
The purpose of the study is to assess the reconstruction and inverse reconstruction in right atrium by speckle tracking echocardiography combined with real-time three dimensional echocardiography for atrial fibrillation patients before and after radiofrequency ablation (RFCA)
Detailed description
The prevalence of atrial fibrillation (AF) has increased in recent years. The construction and function of right atrium haven't shown clearly before and after radiofrequency ablation (RFCA).The purpose of the study is to investigate whether RFCA can lead to inverse reconstruction of right atrium for atrial fibrillation patients, which diagnosing by speckle tracking echocardiography combined with real-time three dimensional echocardiography. All patients will be followed up for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with AF | Experimental | Procedure: radiofrequency ablation (RFCA)Before radiofrequency ablation (RFCA) |
| Assigned Comparisons | Experimental | Procedure: radiofrequency ablation (RFCA)After radiofrequency ablation (RFCA) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- With a history of paroxysmal Af (PAF) and PAF record within 6 months prior to ablation, confirming at least one of the following findings: AF lasting for ≥30 s recorded in Holter or 12-lead ECG.
- No response to more than one antiarrhythmic drug, or unwilling to receive longterm drug treatment.
- Can provide informed consent form expressing willingness to participate in the study and comply with follow-up tests and evaluation procedures.
- Aged 18-80 years.
Key exclusion criteria (10 listed)
- With acute diseases, such as acute phase after myocardial infarction (within 3 months), within 3 months after acute heart failure or new cerebral infarction;
- In the list of heart transplantation;
- Expected survival less than 1 year;
- With other hemorrhagic diseases and anticoagulant therapy is not allowed;
- Thrombosis in left atrium;
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 ablation (RFCA)Patients undergo radiofrequency ablation (RFCA) | Procedure or surgery | Assigned Comparisons, patients with AF |
Primary outcome
Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Time frame: In one week before RFCA
4 secondary outcomes
Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Time frame: In one week after RFCA
Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Time frame: At three months after RFCA
Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Time frame: At six months after RFCA
Adverse event that is related to RFCA, such as the incidence of cardiac tamponade (%) was obtained by echocardiography
Time frame: In one week after RFCA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Results publication: PubMed 24656107Thihalolipavan S, Morin DP. Atrial fibrillation and congestive heart failure. Heart Fail Clin. 2014 Apr;10(2):305-18. doi: 10.1016/j.hfc.2013.12.005. Epub 2014 Feb 4.
- Results publication: PubMed 25634002Extramiana F, Maison-Blanche P. Stroke and atrial fibrillation: where to go from here? Stroke. 2015 Mar;46(3):605-7. doi: 10.1161/STROKEAHA.114.007809. Epub 2015 Jan 29. No abstract available.
- Results publication: PubMed 24685669January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
- Results publication: PubMed 20876603Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available.
- Results publication: PubMed 20445461Rondano E, Dell'Era G, De Luca G, Piccinino C, Bellomo G, Marino PN. Left atrial asynchrony is a major predictor of 1-year recurrence of atrial fibrillation after electrical cardioversion. J Cardiovasc Med (Hagerstown). 2010 Jul;11(7):499-506. doi: 10.2459/JCM.0b013e32833757b5.
- Results publication: PubMed 17627105Wang Z, Tan H, Zhong M, Jiang G, Zhang Y, Zhang W. Strain rate imaging for noninvasive functional quantification of the left atrium in hypertensive patients with paroxysmal atrial fibrillation. Cardiology. 2008;109(1):15-24. doi: 10.1159/000105322. Epub 2007 Jul 10.
- Results publication: PubMed 20889311Lee YS, Hyun DW, Jung BC, Cho YK, Lee SH, Shin DG, Park HS, Han SW, Kim YN; KTK Cardiac Electrophysiology Working Group. Left atrial volume index as a predictor for occurrence of atrial fibrillation after ablation of typical atrial flutter. J Cardiol. 2010 Nov;56(3):348-53. doi: 10.1016/j.jjcc.2010.07.006.
- Results publication: PubMed 24128369Muller H, Reverdin S, Burri H, Shah D, Lerch R. Measurement of left and right atrial volume in patients undergoing ablation for atrial arrhythmias: comparison of a manual versus semiautomatic algorithm of real time 3D echocardiography. Echocardiography. 2014 Apr;31(4):499-507. doi: 10.1111/echo.12391. Epub 2013 Oct 15.
- Results publication: PubMed 23423966Peluso D, Badano LP, Muraru D, Dal Bianco L, Cucchini U, Kocabay G, Kovacs A, Casablanca S, Iliceto S. Right atrial size and function assessed with three-dimensional and speckle-tracking echocardiography in 200 healthy volunteers. Eur Heart J Cardiovasc Imaging. 2013 Nov;14(11):1106-14. doi: 10.1093/ehjci/jet024. Epub 2013 Feb 19.
- Results publication: PubMed 19356538Marwick TH, Leano RL, Brown J, Sun JP, Hoffmann R, Lysyansky P, Becker M, Thomas JD. Myocardial strain measurement with 2-dimensional speckle-tracking echocardiography: definition of normal range. JACC Cardiovasc Imaging. 2009 Jan;2(1):80-4. doi: 10.1016/j.jcmg.2007.12.007.
- Results publication: PubMed 18191740Reant P, Labrousse L, Lafitte S, Bordachar P, Pillois X, Tariosse L, Bonoron-Adele S, Padois P, Deville C, Roudaut R, Dos Santos P. Experimental validation of circumferential, longitudinal, and radial 2-dimensional strain during dobutamine stress echocardiography in ischemic conditions. J Am Coll Cardiol. 2008 Jan 15;51(2):149-57. doi: 10.1016/j.jacc.2007.07.088.
- Results publication: PubMed 21385887Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. Eur J Echocardiogr. 2011 Mar;12(3):167-205. doi: 10.1093/ejechocard/jer021.
- Individual participant dataSharing planned: No
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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.
Kun Sun, M.D.;Ph.D. principal investigator
Department of Ultrasound, Xinhua Hospital, Shanghai Jiaotong 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 (RFCA) in people with Paroxysmal 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 4 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 19 Dec 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 Kun Sun, M.D.;Ph.D. (13651696395, sunkunxh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients (time frame: In one week before RFCA). 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 NCT02838914, 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 19 Dec 2018.