a Novel Individualized Substrate Modification Approach for the Treatment of Long-standing Persistent Atrial Fibrillation

June 17, 2015 updated by: RenJi Hospital

A Prospective Randomized Study of a Novel Individualized Substrate Modification Approach Versus Stepwise Ablation for the Treatment of Long-standing Persistent Atrial Fibrillation

The purpose of this study is to compare effectiveness of two substrate modification approaches in long-standing persistent atrial fibrillation patients, and hypothesized that a substrate-based, individualized substrate modification (ISM)approach should be superior to traditional stepwise ablation(SA). To the best of investigator's knowledge, this was the first study to evaluate the "real" substrate by means of electro-anatomic mapping and to perform "true" substrate modification in long standing persistent atrial fibrillation ablation(LPAF).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Catheter ablation (CA) is highly effective for paroxysmal atrial fibrillation(AF), it is modestly effective for long standing persistent atrial fibrillation ablation(LPAF) even with complex or combined approaches, which is mainly attributed to the substrate underlying AF remodeling. Severity of atrial fibrosis is closely associated with clinical outcomes after CA for AF . The more atrial scars and fibrosis present, the lower the success rate for AF ablation. Patients with LPAF have many more areas with scars and fibrosis than those with paroxysmal AF or non-AF controls. The MRI delayed enhancement technique provides a non-interventional tool for evaluation of atrial fibrosis, however, it must be performed in sinus rhythm.Three-dimensional electro anatomic mapping has proven as accurate as MRI and can be performed easily during AF ablation, thus providing a good tool for evaluation of atrial substrate during LPAF ablation.

Although electro-anatomic mapping provided a desirable surrogate for delayed enhancement MRI to define AF substrate, there was an important technical issue to be considered. There were no good techniques to predict a desirable tip-tissue contact before the contact force catheter was applied. A poor tip-tissue contact could render the results of voltage mapping less reliable. On the other hand, excessively high contact force could increase the risk of steam pop and cardiac perforation during ablation. Hence it was important to use the contact force catheter to perform substrate mapping and ablation.

Study Type

Interventional

Enrollment (Anticipated)

220

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

  • Name: Xinhua Wang, MD,PHD
  • Phone Number: 862168385206
  • Email: ttwwxh@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Shanghai Jiaotong University School of Medicine,Renji Hospital
        • Contact:
          • Xinhua Wang, MD,PHD
          • Phone Number: 862168385206
          • Email: ttwwxh@126.com

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 72 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 and ≤ 72years
  • History of LPAF for ≥1 and ≤ 5 years
  • Written informed consent provided
  • Acceptance of catheter ablation treatment
  • Acceptance of post-ablation follow-up

Exclusion Criteria:

  • Prior history of catheter ablation or surgical ablation
  • Abnormal coagulation; contraindication for anti-coagulation
  • left atrium diameter ≥ 55mm
  • left atrium thrombus

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Individualized substrate modification
Circumferential pulmonary vein isolation(CPVI) ablation and left atrial roof linear ablation first,then substrate mapping in sinus rhythm followed by Individualized substrate modification.
Procedure: individualized substrate modification
CPVI ablation and left atrial roof linear ablation first,then substrate mapping in sinus rhythm followed by individualized substrate modification.
ACTIVE_COMPARATOR: Stepwise ablation
CPVI ablation,left atrial roof linear ablation,mitral isthmus linear ablation,complex fractionated atrial electrograms ablation step by step.
Procedure: stepwise ablation
CPVI ablation,left atrial roof linear ablation,mitral isthmus linear ablation,complex fractionated atrial electrograms ablation step by step.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
atrial fibrillation free rate on or off antiarrhythmic drugs (AADs) after initial ablation
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse event
Time Frame: 1 year
pericardial tamponade and thromboembolism event
1 year
Prevalence of recurrent atrial flutter
Time Frame: 1 year
1 year
Proportion of pulmonary vein isolation
Time Frame: 1 year
1 year
Proportion of acute pulmonary vein re-connection
Time Frame: 1 year
1 year
Fluoroscopy exposure time
Time Frame: 1 year
1 year
Total ablation time
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Collaborators

Biosense Webster, Inc.

Investigators

  • Principal Investigator: Xinhua Wang, MD,PHD, Shanghai Jiao Tong University School of Medicine

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

January 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2016

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (ESTIMATE)

June 23, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 仁济伦审[2014]116K

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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