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

September 18, 2016 updated by: Yan Yao, MD,PhD, China National Center for Cardiovascular Diseases

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • China National Center for Cardiovascular Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From August, 2016 to July 2019. The overall Time Frame for AF recurrence is being assessed up to 36 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
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

Outcome Measure
Time Frame
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.
From August, 2016 to July 2017. The overall Time Frame for average ablation time and procedure time are being assessed up to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Collaborators

First Affiliated Hospital, Sun Yat-Sen University
Beijing Hospital
Tianjin Medical University General Hospital
The First Affiliated Hospital of Kunming Medical College
Wuhan Asia Heart Hospital

Investigators

  • Principal Investigator: Yan Yao, MD,PhD, China National Center for Cardiovascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

August 27, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 18, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-ZX51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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