Persistent Atrial FibrillationCLEAR-AFNCT02892162
Catheter Ablation Therapy for Persistent Atrial Fibrillation
A study testing Additional LAAW linear ablation in people with Persistent Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%). The investigators' previous study indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with the LA roof and mitral isthmus appearing… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Additional LAAW linear ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The main inclusion criterion is patients suffering from drug refractory persistent atrial fibrillation and referred to catheter ablation therapy. Persistent AF is defined as continuous AF for over 7 days, or lasting no more than 7 days but requiring pharmacological or electrical cardioversion.
Who cannot join
- Patients without spontaneous ongoing AF at the beginning of the procedure;
- Age: <18 years or >70 years;
- LA size > 55mm measured on echocardiogram;
- Previous AF ablation history including surgical ablation;
- Documented LA thrombus;
- Severe pulmonary diseases;
- Previous cardiac surgical history.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Yan Yao, MD, PhD, +86-13901121319, ianyao@263.net.cn
Lingmin Wu, MD, PhD, +86-18810488351, wlmxt2008@126.com
About this study
Official title: Catheter Ablation Therapy for Persistent Atrial Fibrillation: Value of Additional Linear Ablation on Left Atrial Anterior Wall
Use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%). The investigators' previous study indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with the LA roof and mitral isthmus appearing to serve as main substrate in progression from PAF to PerAF and maintenance of fibrillatory activities. The investigators therefore hypothesized that AF should not be initiated or sustained if the latter crucial regions for AF maintenance are abolished. This study aimed to describe the efficacy and safety of additional linear ablation on the left atrial anterior wall for PerAF.
Read the detailed description
Although studies and guidelines have helped establish catheter ablation as preferred treatment for patients suffering from paroxysmal atrial fibrillation (PAF), use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%).
The investigators' study indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with the LA roof and mitral isthmus appearing to serve as main substrate in progression from PAF to PerAF and maintenance of fibrillatory activities. The investigators therefore hypothesized that AF should not be initiated or sustained if the latter crucial regions for AF maintenance are abolished. This was confirmed using a stepwise pure linear ablation protocol, consisting of a line across the LA roof and extending along the anterior wall of pulmonary veins (PV) antrum to mitral valve annulus (MVA) without PV isolation; the approach appeared safe and effective with long-term (5.2 years) follow-up success rate of 40% for PerAF.
This study will evaluate efficacy and safety of circumferential pulmonary vein isolation (CPVI) + LA roof linear ablation + LA anterior wall (LAAW) linear ablation combined with high density mapping and contact force sensing techniques for perAF. This study is expected to provide a practical and guided catheter ablation strategy with maximized safety and efficacy through use of contact force sensing technique, which will be accepted by other qualified electrophysiology laboratories.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Additional LAAW linear ablation
- Keywords
- atrial fibrillation, catheter 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.
Additional LAAW linear ablationProcedure or surgery
Additional linear ablation on LAAW using ThermoCool SmartTouch ablation catheter.
| Study group | Role | What they receive |
|---|---|---|
| With additional LAAW linear ablation | Experimental | Patients who undergo CPVI+LA roof linear ablation+/ MI linear ablation, and additional LAAW linear ablation using ThermoCool SmartTouch catheter. Receives: Procedure: Additional LAAW linear ablation |
| Without additional LAAW linear ablation | Active comparator | Patients who undergo CPVI+LA roof +/ MI linear ablation using ThermoCool SmartTouch catheter, without LAAW linear ablation. Receives: Procedure: Additional LAAW linear ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF recurrence
Freedom from AF at 1 year without any anti-arrhythmic drugs. Recurrent AF is defined as documented AF (through 12-lead ECG or Holter) period lasting >30 seconds after a 3-month blanking period.
Measured: From August, 2016 to July 2019. The overall Time Frame for AF recurrence is being assessed up to 36 months.
Secondary outcomes (4)
Acute success rate of AF termination during ablation procedure
Measured: From August, 2016 to July 2017. The overall Time Frame for AF termination during ablation procedure is being assessed up to 12 months.
Frequency of complications
Measured: From August, 2016 to July 2017. The overall Time Frame for frequency of complications is being assessed up to 12 months.
Average radiation exposure
Measured: From August, 2016 to July 2017. The overall Time Frame for average radiation exposure is being assessed up to 12 months.
Frequency of redo procedures
Measured: From August, 2016 to July 2019. The overall Time Frame for frequency of redo procedures is being assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Beijing Hospital, First Affiliated Hospital, Sun Yat-Sen University, Tianjin Medical University General Hospital, Wuhan Asia Heart Hospital, First Affiliated Hospital of Kunming Medical University
- Responsible party
- Principal investigator, Yan Yao, MD,PhD, China National Center for Cardiovascular Diseases
- Investigators
- Yan Yao, MD,PhD, Principal investigator, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892162
- Sponsor's protocol ID
- 2015-ZX51
- Acronym
- CLEAR-AF
- Status last verified
- Sep 2016
- First submitted
- 27 Aug 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
January 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; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):2071-104. doi: 10.1161/CIR.0000000000000040. Epub 2014 Mar 28. No abstract available.
PubMed 24682348Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.
PubMed 22922413Chao TF, Tsao HM, Lin YJ, Tsai CF, Lin WS, Chang SL, Lo LW, Hu YF, Tuan TC, Suenari K, Li CH, Hartono B, Chang HY, Ambrose K, Wu TJ, Chen SA. Clinical outcome of catheter ablation in patients with nonparoxysmal atrial fibrillation: results of 3-year follow-up. Circ Arrhythm Electrophysiol. 2012 Jun 1;5(3):514-20. doi: 10.1161/CIRCEP.111.968032. Epub 2012 May 1.
PubMed 22550126Tilz RR, Rillig A, Thum AM, Arya A, Wohlmuth P, Metzner A, Mathew S, Yoshiga Y, Wissner E, Kuck KH, Ouyang F. Catheter ablation of long-standing persistent atrial fibrillation: 5-year outcomes of the Hamburg Sequential Ablation Strategy. J Am Coll Cardiol. 2012 Nov 6;60(19):1921-9. doi: 10.1016/j.jacc.2012.04.060. Epub 2012 Oct 10.
PubMed 23062545Sorgente A, Tung P, Wylie J, Josephson ME. Six year follow-up after catheter ablation of atrial fibrillation: a palliation more than a true cure. Am J Cardiol. 2012 Apr 15;109(8):1179-86. doi: 10.1016/j.amjcard.2011.11.058. Epub 2012 Jan 14.
PubMed 22245414Yao Y, Zheng L, Zhang S, He DS, Zhang K, Tang M, Chen K, Pu J, Wang F, Chen X. Stepwise linear approach to catheter ablation of atrial fibrillation. Heart Rhythm. 2007 Dec;4(12):1497-504. doi: 10.1016/j.hrthm.2007.07.028. Epub 2007 Aug 11.
PubMed 17997359Wu L, Yao Y, Zheng L, Zhang K, Zhang S. Long-term follow-up of pure linear ablation for persistent atrial fibrillation without circumferential pulmonary vein isolation. J Cardiovasc Electrophysiol. 2014 May;25(5):471-476. doi: 10.1111/jce.12360. Epub 2014 Jan 24.
PubMed 24400694
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation Therapy for Persistent Atrial Fibrillation: Value of Additional Linear Ablation on Left Atrial Anterior Wall
- ClinicalTrials.gov ID
- NCT02892162
- Acronym / sponsor ID
- CLEAR-AF / 2015-ZX51
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Beijing Hospital, First Affiliated Hospital, Sun Yat-Sen University, Tianjin Medical University General Hospital, Wuhan Asia Heart Hospital, First Affiliated Hospital of Kunming Medical University
- Study start
- Aug 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 8 Sep 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.
Use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%). The investigators' previous study indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with the LA roof and mitral isthmus appearing to serve as main substrate in progression from PAF to PerAF and maintenance of fibrillatory activities. The investigators therefore hypothesized that AF should not be initiated or sustained if the latter crucial regions for AF maintenance are abolished. This study aimed to describe the efficacy and safety of additional linear ablation on the left atrial anterior wall for PerAF.
Detailed description
Although studies and guidelines have helped establish catheter ablation as preferred treatment for patients suffering from paroxysmal atrial fibrillation (PAF), use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%).
The investigators' study indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with the LA roof and mitral isthmus appearing to serve as main substrate in progression from PAF to PerAF and maintenance of fibrillatory activities. The investigators therefore hypothesized that AF should not be initiated or sustained if the latter crucial regions for AF maintenance are abolished. This was confirmed using a stepwise pure linear ablation protocol, consisting of a line across the LA roof and extending along the anterior wall of pulmonary veins (PV) antrum to mitral valve annulus (MVA) without PV isolation; the approach appeared safe and effective with long-term (5.2 years) follow-up success rate of 40% for PerAF.
This study will evaluate efficacy and safety of circumferential pulmonary vein isolation (CPVI) + LA roof linear ablation + LA anterior wall (LAAW) linear ablation combined with high density mapping and contact force sensing techniques for perAF. This study is expected to provide a practical and guided catheter ablation strategy with maximized safety and efficacy through use of contact force sensing technique, which will be accepted by other qualified electrophysiology laboratories.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With additional LAAW linear ablation | Experimental | Procedure: Additional LAAW linear ablationPatients who undergo CPVI+LA roof linear ablation+/ MI linear ablation, and additional LAAW linear ablation using ThermoCool SmartTouch catheter. |
| Without additional LAAW linear ablation | Active comparator | Procedure: Additional LAAW linear ablationPatients who undergo CPVI+LA roof +/ MI linear ablation using ThermoCool SmartTouch catheter, without LAAW linear ablation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The main inclusion criterion is patients suffering from drug refractory persistent atrial fibrillation and referred to catheter ablation therapy. Persistent AF is defined as continuous AF for over 7 days, or lasting no more than 7 days but requiring pharmacological or electrical cardioversion.
Key exclusion criteria (7 listed)
- Patients without spontaneous ongoing AF at the beginning of the procedure;
- Age: <18 years or >70 years;
- LA size > 55mm measured on echocardiogram;
- Previous AF ablation history including surgical ablation;
- Documented LA thrombus;
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 |
|---|---|---|
| Additional LAAW linear ablationAdditional linear ablation on LAAW using ThermoCool SmartTouch ablation catheter. | Procedure or surgery | With additional LAAW linear ablation, Without additional LAAW linear ablation |
Primary outcome
AF recurrence
Time frame: From August, 2016 to July 2019. The overall Time Frame for AF recurrence is being assessed up to 36 months.
Freedom from AF at 1 year without any anti-arrhythmic drugs. Recurrent AF is defined as documented AF (through 12-lead ECG or Holter) period lasting >30 seconds after a 3-month blanking period.
4 secondary outcomes
Acute success rate of AF termination during ablation procedure
Time frame: From August, 2016 to July 2017. The overall Time Frame for AF termination during ablation procedure is being assessed up to 12 months.
Frequency of complications
Time frame: From August, 2016 to July 2017. The overall Time Frame for frequency of complications is being assessed up to 12 months.
Average radiation exposure
Time frame: From August, 2016 to July 2017. The overall Time Frame for average radiation exposure is being assessed up to 12 months.
Frequency of redo procedures
Time frame: From August, 2016 to July 2019. The overall Time Frame for frequency of redo procedures is being assessed up to 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Background: PubMed 24682348January 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; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):2071-104. doi: 10.1161/CIR.0000000000000040. Epub 2014 Mar 28. No abstract available.
- Background: PubMed 22922413Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.
- Background: PubMed 22550126Chao TF, Tsao HM, Lin YJ, Tsai CF, Lin WS, Chang SL, Lo LW, Hu YF, Tuan TC, Suenari K, Li CH, Hartono B, Chang HY, Ambrose K, Wu TJ, Chen SA. Clinical outcome of catheter ablation in patients with nonparoxysmal atrial fibrillation: results of 3-year follow-up. Circ Arrhythm Electrophysiol. 2012 Jun 1;5(3):514-20. doi: 10.1161/CIRCEP.111.968032. Epub 2012 May 1.
- Background: PubMed 23062545Tilz RR, Rillig A, Thum AM, Arya A, Wohlmuth P, Metzner A, Mathew S, Yoshiga Y, Wissner E, Kuck KH, Ouyang F. Catheter ablation of long-standing persistent atrial fibrillation: 5-year outcomes of the Hamburg Sequential Ablation Strategy. J Am Coll Cardiol. 2012 Nov 6;60(19):1921-9. doi: 10.1016/j.jacc.2012.04.060. Epub 2012 Oct 10.
- Background: PubMed 22245414Sorgente A, Tung P, Wylie J, Josephson ME. Six year follow-up after catheter ablation of atrial fibrillation: a palliation more than a true cure. Am J Cardiol. 2012 Apr 15;109(8):1179-86. doi: 10.1016/j.amjcard.2011.11.058. Epub 2012 Jan 14.
- Background: PubMed 17997359Yao Y, Zheng L, Zhang S, He DS, Zhang K, Tang M, Chen K, Pu J, Wang F, Chen X. Stepwise linear approach to catheter ablation of atrial fibrillation. Heart Rhythm. 2007 Dec;4(12):1497-504. doi: 10.1016/j.hrthm.2007.07.028. Epub 2007 Aug 11.
- Background: PubMed 24400694Wu L, Yao Y, Zheng L, Zhang K, Zhang S. Long-term follow-up of pure linear ablation for persistent atrial fibrillation without circumferential pulmonary vein isolation. J Cardiovasc Electrophysiol. 2014 May;25(5):471-476. doi: 10.1111/jce.12360. Epub 2014 Jan 24.
- Individual participant dataSharing planned: No
Related trials for Persistent Atrial Fibrillation
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Not yet recruiting
Dual-Energy Lattice-Tip Assisted Marshall-Plan Strategy in Redo Persistent Atrial Fibrillation Ablation
Atrial Fibrillation (AF)
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
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.
Yan Yao, MD,PhD principal investigator
China National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional LAAW linear ablation in people with Persistent 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 1 inclusion and 7 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 20 Sep 2016. 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 Yan Yao, MD,PhD (+86-13901121319, ianyao@263.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF recurrence (time frame: From August, 2016 to July 2019. The overall Time Frame for AF recurrence is being assessed up to 36 months.). 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 NCT02892162, which also lists 7 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 20 Sep 2016.