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Catheter Ablation Therapy for Persistent Atrial Fibrillation (CLEAR-AF)

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ClinicalTrials.gov Identifier: NCT02892162
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : September 20, 2016
Sponsor:
Collaborators:
Beijing Hospital
First Affiliated Hospital, Sun Yat-Sen University
Tianjin Medical University General Hospital
Wuhan Asia Heart Hospital
The First Affiliated Hospital of Kunming Medical College
Information provided by (Responsible Party):
Yan Yao, MD,PhD, China National Center for Cardiovascular Diseases

Brief 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 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.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Procedure: Additional LAAW linear ablation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Catheter Ablation Therapy for Persistent Atrial Fibrillation: Value of Additional Linear Ablation on Left Atrial Anterior Wall
Study Start Date : August 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: With additional LAAW linear ablation
Patients who undergo CPVI+LA roof linear ablation+/ MI linear ablation, and additional LAAW linear ablation using ThermoCool SmartTouch catheter.
Procedure: Additional LAAW linear ablation
Additional linear ablation on LAAW using ThermoCool SmartTouch ablation catheter.

Active Comparator: Without additional LAAW linear ablation
Patients who undergo CPVI+LA roof +/ MI linear ablation using ThermoCool SmartTouch catheter, without LAAW linear ablation.
Procedure: Additional LAAW linear ablation
Additional linear ablation on LAAW using ThermoCool SmartTouch ablation catheter.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]

Other Outcome Measures:
  1. Average ablation time and procedure time [ Time Frame: From August, 2016 to July 2017. The overall Time Frame for average ablation time and procedure time are being assessed up to 12 months. ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

  1. Patients without spontaneous ongoing AF at the beginning of the procedure;
  2. Age: <18 years or >70 years;
  3. LA size > 55mm measured on echocardiogram;
  4. Previous AF ablation history including surgical ablation;
  5. Documented LA thrombus;
  6. Severe pulmonary diseases;
  7. Previous cardiac surgical history.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892162


Contacts
Contact: Yan Yao, MD,PhD +86-13901121319 ianyao@263.net.cn
Contact: Lingmin Wu, MD,PhD +86-18810488351 wlmxt2008@126.com

Locations
China, Beijing
China National Center for Cardiovascular Diseases Recruiting
Beijing, Beijing, China, 100037
Contact: Yan Yao, MD, PhD    +86-13901121319    ianyao@263.net.cn   
Contact: Lingmin Wu, MD, PhD    +86-18810488351    wlmxt2008@126.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Beijing Hospital
First Affiliated Hospital, Sun Yat-Sen University
Tianjin Medical University General Hospital
Wuhan Asia Heart Hospital
The First Affiliated Hospital of Kunming Medical College
Investigators
Principal Investigator: Yan Yao, MD,PhD China National Center for Cardiovascular Diseases

Publications:

Responsible Party: Yan Yao, MD,PhD, Principal Investigator, China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT02892162     History of Changes
Other Study ID Numbers: 2015-ZX51
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yan Yao, MD,PhD, China National Center for Cardiovascular Diseases:
atrial fibrillation
catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes