Paroxysmal Atrial FibrillationNCT02637453
Addition of Six Short Lines on Pulmonary Vein Isolation
A study testing PVI and CPVI+6L in people with Paroxysmal Atrial Fibrillation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). 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?
- PVI and CPVI+6L
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2017to 10 Jan 2021
- 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
- Patients between the ages of 18 and 80 years undergoing their first ablation of atrial fibrillation.
- Diagnosed with symptomatic paroxysmal atrial fibrillation, defined as an documented episode of atrial fibrillation that lasts more than 30 seconds and terminates in less than 7 days.
- Resistant or intolerant to at least one class I, II, or III antiarrhythmic drugs.
- Patients deemed candidates for radiofrequency ablation of atrial fibrillation.
- Able and willing to comply with pre-, post-, and follow-up requirements.
Who cannot join
- Left atrial thrombus by pre-procedural imaging.
- Uncontrolled heart failure: New York Heart Association Class III or IV, or left ventricular ejection fraction< 40%
- Myocardial infarction, unstable angina, coronary stenting within the previous 90 days.
- Stroke or any thrombo-embolic events within the previous 90 days.
- Expecting cardiac transplantation or other cardiac surgery within 180 days.
- History of catheter ablation of atrial fibrillation, atrial flutter or atrial tachycardia.
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- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation.
- History of cardiac surgery.
- Uncontrolled maligment tumor.
- Patients in dialysis or creatinine > 221 μmol/L.
- Patients with alanine aminotransferase > 150 U/L or aspartate aminotransferase > 76 U/L
- Acute illness or active infection at time of index procedure or leukocytosis for which antibiotics have been or will be prescribed.
- Life expectancy less than 1 year.
- Women who are pregnant or who plan to become pregnant during the study.
- Other significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital, Shanghai Jiao Tong University School of Medicne
Shanghai, Shanghai Municipality, 200092
About this study
Official title: Addition of Six Short Ablation Lines on Pulmonary Vein Isolation Circumferences Reduces Recurrence Rate of Paroxysmal Atrial Fibrillation
We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.
Read the detailed description
We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- PVI, CPVI+6L
- Keywords
- Paroxysmal Atrial Fibrillation; 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.
PVIProcedure or surgery
Pulmonary vein isolation
CPVI+6LProcedure or surgery
After PVI, 6 ablation lines were added with an extension from pulmonary vein ostium at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV
| Study group | Role | What they receive |
|---|---|---|
| PVI | Active comparator | Pulmonary vein isolation (PVI) Receives: Procedure: PVI |
| PVI+6L | Experimental | PVI plus 6 additional lines at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV Receives: Procedure: CPVI+6L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from AF recurrence between 91 and 365 days
AF recurrence was defined by AF (including atrial flutter or atrial tachycardia) of 30 seconds or more captured by ECG monitoring or any clinical presentation with AF outside the 90-day blanking period (between 91 and 365 days). Cardioversion, or use of class I or III antiarrhythmic drugs outside blanking period was also considered as AF recurrence.
Measured: 91 to 365 days
Secondary outcomes (6)
AF burden
Percentage of time in AF, atrial flutter or atrial tachycardia on 14-days continuous monitoring at 12 months.
Measured: 12 months
Procedural time
Total procedural time from femoral vein puncture to decannulation (skin-to-skin time)
Measured: Within procedure
Fluoroscopy time
Time of patients' exposure to the real-time X-ray imaging during the procedure.
Measured: Within procedure
Ablation time
Radiofrequency delivery time during the procedure.
Measured: Within procedure
Early onset complications
Complications within 30 days post-ablation, including death, myocardial infarction, diaphragmatic paralysis, stroke or transient ischemic attack, systemic embolism, pericardial effusion or tamponade requiring drainage, heart block, pericarditis, and vascular access complications requiring intervention.
Measured: Within 30 days
Late onset complications
Complications detected any time during the follow-up, including severe pulmonary vein stenosis (>70%), and atrioesophageal fistula.
Measured: within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start4 Jan 2017
- Primary completion10 Jan 2021
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Participant
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xuzhou Central Hospital, Shanghai East Hospital, Shanghai Chest Hospital
- Responsible party
- Principal investigator, Yi-Gang Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yi-Gang Li, MD., Principal investigator, Department of Cardiology, Xinhua Hospital, Shanghai Jiaotong University School of Medicne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637453
- Sponsor's protocol ID
- ShanghaiXinhua-Af
- Status last verified
- Apr 2021
- First submitted
- 16 Dec 2015
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Steinberg BA, Beckley PD, Deering TF, Clark CL, Amin AN, Bauer KA, Cryer B, Mansour M, Scheiman JM, Zenati MA, Newby LK, Peacock WF, Bhatt DL; Society of Cardiovascular Patient Care. Evaluation and management of the atrial fibrillation patient: a report from the Society of Cardiovascular Patient Care. Crit Pathw Cardiol. 2013 Sep;12(3):107-15. doi: 10.1097/HPC.0b013e31829834ed.
PubMed 23892939Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.
PubMed 9725923Zhang S. Atrial fibrillation in mainland China: epidemiology and current management. Heart. 2009 Jul;95(13):1052-5. doi: 10.1136/hrt.2008.146589. Epub 2009 Mar 23.
PubMed 19318342Weerasooriya R, Khairy P, Litalien J, Macle L, Hocini M, Sacher F, Lellouche N, Knecht S, Wright M, Nault I, Miyazaki S, Scavee C, Clementy J, Haissaguerre M, Jais P. Catheter ablation for atrial fibrillation: are results maintained at 5 years of follow-up? J Am Coll Cardiol. 2011 Jan 11;57(2):160-6. doi: 10.1016/j.jacc.2010.05.061.
PubMed 21211687Cheema A, Vasamreddy CR, Dalal D, Marine JE, Dong J, Henrikson CA, Spragg D, Cheng A, Nazarian S, Sinha S, Halperin H, Berger R, Calkins H. Long-term single procedure efficacy of catheter ablation of atrial fibrillation. J Interv Card Electrophysiol. 2006 Apr;15(3):145-55. doi: 10.1007/s10840-006-9005-9. Epub 2006 Aug 5.
PubMed 17019636Ouyang F, Tilz R, Chun J, Schmidt B, Wissner E, Zerm T, Neven K, Kokturk B, Konstantinidou M, Metzner A, Fuernkranz A, Kuck KH. Long-term results of catheter ablation in paroxysmal atrial fibrillation: lessons from a 5-year follow-up. Circulation. 2010 Dec 7;122(23):2368-77. doi: 10.1161/CIRCULATIONAHA.110.946806. Epub 2010 Nov 22.
PubMed 21098450Calo L, Rebecchi M, Sciarra L, De Luca L, Fagagnini A, Zuccaro LM, Pitrone P, Dottori S, Porfirio M, de Ruvo E, Lioy E. Catheter ablation of right atrial ganglionated plexi in patients with vagal paroxysmal atrial fibrillation. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):22-31. doi: 10.1161/CIRCEP.111.964262. Epub 2011 Dec 6.
PubMed 22147839Katritsis DG, Pokushalov E, Romanov A, Giazitzoglou E, Siontis GC, Po SS, Camm AJ, Ioannidis JP. Autonomic denervation added to pulmonary vein isolation for paroxysmal atrial fibrillation: a randomized clinical trial. J Am Coll Cardiol. 2013 Dec 17;62(24):2318-25. doi: 10.1016/j.jacc.2013.06.053. Epub 2013 Aug 21.
PubMed 23973694Noheria A, Kumar A, Wylie JV Jr, Josephson ME. Catheter ablation vs antiarrhythmic drug therapy for atrial fibrillation: a systematic review. Arch Intern Med. 2008 Mar 24;168(6):581-6. doi: 10.1001/archinte.168.6.581.
PubMed 18362249Stabile G, Bertaglia E, Senatore G, De Simone A, Zoppo F, Donnici G, Turco P, Pascotto P, Fazzari M, Vitale DF. Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study). Eur Heart J. 2006 Jan;27(2):216-21. doi: 10.1093/eurheartj/ehi583. Epub 2005 Oct 7.
PubMed 16214831Wilber DJ, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud EG, Calkins H, Hall B, Reddy V, Augello G, Reynolds MR, Vinekar C, Liu CY, Berry SM, Berry DA; ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):333-40. doi: 10.1001/jama.2009.2029.
PubMed 20103757Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J, Shah D, Michaud G, Wharton M, Harari D, Mahapatra S, Lambert H, Mansour M. Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study. Circulation. 2015 Sep 8;132(10):907-15. doi: 10.1161/CIRCULATIONAHA.114.014092. Epub 2015 Aug 10.
PubMed 26260733
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Six Short Ablation Lines on Pulmonary Vein Isolation Circumferences Reduces Recurrence Rate of Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02637453
- Acronym / sponsor ID
- ShanghaiXinhua-Af
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Paroxysmal Atrial Fibrillation; Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Xuzhou Central Hospital, Shanghai East Hospital, Shanghai Chest Hospital
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 22 Dec 2015 (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.
We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.
Detailed description
We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI | Active comparator | Procedure: PVIPulmonary vein isolation (PVI) |
| PVI+6L | Experimental | Procedure: CPVI+6LPVI plus 6 additional lines at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients between the ages of 18 and 80 years undergoing their first ablation of atrial fibrillation.
- Diagnosed with symptomatic paroxysmal atrial fibrillation, defined as an documented episode of atrial fibrillation that lasts more than 30 seconds and terminates in less than 7 days.
- Resistant or intolerant to at least one class I, II, or III antiarrhythmic drugs.
- Patients deemed candidates for radiofrequency ablation of atrial fibrillation.
- Able and willing to comply with pre-, post-, and follow-up requirements.
Key exclusion criteria (16 listed)
- Left atrial thrombus by pre-procedural imaging.
- Uncontrolled heart failure: New York Heart Association Class III or IV, or left ventricular ejection fraction< 40%
- Myocardial infarction, unstable angina, coronary stenting within the previous 90 days.
- Stroke or any thrombo-embolic events within the previous 90 days.
- Expecting cardiac transplantation or other cardiac surgery within 180 days.
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 |
|---|---|---|
| PVIPulmonary vein isolation | Procedure or surgery | PVI |
| CPVI+6LAfter PVI, 6 ablation lines were added with an extension from pulmonary vein ostium at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV | Procedure or surgery | PVI+6L |
Primary outcome
Freedom from AF recurrence between 91 and 365 days
Time frame: 91 to 365 days
AF recurrence was defined by AF (including atrial flutter or atrial tachycardia) of 30 seconds or more captured by ECG monitoring or any clinical presentation with AF outside the 90-day blanking period (between 91 and 365 days). Cardioversion, or use of class I or III antiarrhythmic drugs outside blanking period was also considered as AF recurrence.
6 secondary outcomes
AF burden
Time frame: 12 months
Procedural time
Time frame: Within procedure
Fluoroscopy time
Time frame: Within procedure
Ablation time
Time frame: Within procedure
Early onset complications
Time frame: Within 30 days
Late onset complications
Time frame: within 12 months
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 15 Jun 2021.
- Background: PubMed 23892939Steinberg BA, Beckley PD, Deering TF, Clark CL, Amin AN, Bauer KA, Cryer B, Mansour M, Scheiman JM, Zenati MA, Newby LK, Peacock WF, Bhatt DL; Society of Cardiovascular Patient Care. Evaluation and management of the atrial fibrillation patient: a report from the Society of Cardiovascular Patient Care. Crit Pathw Cardiol. 2013 Sep;12(3):107-15. doi: 10.1097/HPC.0b013e31829834ed.
- Background: PubMed 9725923Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.
- Background: PubMed 19318342Zhang S. Atrial fibrillation in mainland China: epidemiology and current management. Heart. 2009 Jul;95(13):1052-5. doi: 10.1136/hrt.2008.146589. Epub 2009 Mar 23.
- Background: PubMed 21211687Weerasooriya R, Khairy P, Litalien J, Macle L, Hocini M, Sacher F, Lellouche N, Knecht S, Wright M, Nault I, Miyazaki S, Scavee C, Clementy J, Haissaguerre M, Jais P. Catheter ablation for atrial fibrillation: are results maintained at 5 years of follow-up? J Am Coll Cardiol. 2011 Jan 11;57(2):160-6. doi: 10.1016/j.jacc.2010.05.061.
- Background: PubMed 17019636Cheema A, Vasamreddy CR, Dalal D, Marine JE, Dong J, Henrikson CA, Spragg D, Cheng A, Nazarian S, Sinha S, Halperin H, Berger R, Calkins H. Long-term single procedure efficacy of catheter ablation of atrial fibrillation. J Interv Card Electrophysiol. 2006 Apr;15(3):145-55. doi: 10.1007/s10840-006-9005-9. Epub 2006 Aug 5.
- Background: PubMed 21098450Ouyang F, Tilz R, Chun J, Schmidt B, Wissner E, Zerm T, Neven K, Kokturk B, Konstantinidou M, Metzner A, Fuernkranz A, Kuck KH. Long-term results of catheter ablation in paroxysmal atrial fibrillation: lessons from a 5-year follow-up. Circulation. 2010 Dec 7;122(23):2368-77. doi: 10.1161/CIRCULATIONAHA.110.946806. Epub 2010 Nov 22.
- Background: PubMed 22147839Calo L, Rebecchi M, Sciarra L, De Luca L, Fagagnini A, Zuccaro LM, Pitrone P, Dottori S, Porfirio M, de Ruvo E, Lioy E. Catheter ablation of right atrial ganglionated plexi in patients with vagal paroxysmal atrial fibrillation. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):22-31. doi: 10.1161/CIRCEP.111.964262. Epub 2011 Dec 6.
- Background: PubMed 23973694Katritsis DG, Pokushalov E, Romanov A, Giazitzoglou E, Siontis GC, Po SS, Camm AJ, Ioannidis JP. Autonomic denervation added to pulmonary vein isolation for paroxysmal atrial fibrillation: a randomized clinical trial. J Am Coll Cardiol. 2013 Dec 17;62(24):2318-25. doi: 10.1016/j.jacc.2013.06.053. Epub 2013 Aug 21.
- Background: PubMed 18362249Noheria A, Kumar A, Wylie JV Jr, Josephson ME. Catheter ablation vs antiarrhythmic drug therapy for atrial fibrillation: a systematic review. Arch Intern Med. 2008 Mar 24;168(6):581-6. doi: 10.1001/archinte.168.6.581.
- Background: PubMed 16214831Stabile G, Bertaglia E, Senatore G, De Simone A, Zoppo F, Donnici G, Turco P, Pascotto P, Fazzari M, Vitale DF. Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study). Eur Heart J. 2006 Jan;27(2):216-21. doi: 10.1093/eurheartj/ehi583. Epub 2005 Oct 7.
- Background: PubMed 20103757Wilber DJ, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud EG, Calkins H, Hall B, Reddy V, Augello G, Reynolds MR, Vinekar C, Liu CY, Berry SM, Berry DA; ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):333-40. doi: 10.1001/jama.2009.2029.
- Background: PubMed 26260733Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J, Shah D, Michaud G, Wharton M, Harari D, Mahapatra S, Lambert H, Mansour M. Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study. Circulation. 2015 Sep 8;132(10):907-15. doi: 10.1161/CIRCULATIONAHA.114.014092. Epub 2015 Aug 10.
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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.
Yi-Gang Li, MD. principal investigator
Department of Cardiology, Xinhua Hospital, Shanghai Jiaotong University School of Medicne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI and CPVI+6L 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 5 inclusion and 16 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 15 Jun 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?
Freedom from AF recurrence between 91 and 365 days (time frame: 91 to 365 days). 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 NCT02637453, which also lists 12 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 15 Jun 2021.