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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
individualized substrate modification
stepwise ablation
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring long standing persistent atrial fibrillation, novel approach, ablation

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Jiaotong University school of medicine,Renji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individualized substrate modification

Stepwise ablation

Arm Description

Circumferential pulmonary vein isolation(CPVI) ablation and left atrial roof linear ablation first,then substrate mapping in sinus rhythm followed by Individualized substrate modification.

CPVI ablation,left atrial roof linear ablation,mitral isthmus linear ablation,complex fractionated atrial electrograms ablation step by step.

Outcomes

Primary Outcome Measures

atrial fibrillation free rate on or off antiarrhythmic drugs (AADs) after initial ablation

Secondary Outcome Measures

Number of participants with adverse event
pericardial tamponade and thromboembolism event
Prevalence of recurrent atrial flutter
Proportion of pulmonary vein isolation
Proportion of acute pulmonary vein re-connection
Fluoroscopy exposure time
Total ablation time

Full Information

First Posted
June 8, 2015
Last Updated
June 17, 2015
Sponsor
RenJi Hospital
Collaborators
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02477592
Brief Title
a Novel Individualized Substrate Modification Approach for the Treatment of Long-standing Persistent Atrial Fibrillation
Official Title
A Prospective Randomized Study of a Novel Individualized Substrate Modification Approach Versus Stepwise Ablation for the Treatment of Long-standing Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
Collaborators
Biosense Webster, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
long standing persistent atrial fibrillation, novel approach, ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individualized substrate modification
Arm Type
Experimental
Arm Description
Circumferential pulmonary vein isolation(CPVI) ablation and left atrial roof linear ablation first,then substrate mapping in sinus rhythm followed by Individualized substrate modification.
Arm Title
Stepwise ablation
Arm Type
Active Comparator
Arm Description
CPVI ablation,left atrial roof linear ablation,mitral isthmus linear ablation,complex fractionated atrial electrograms ablation step by step.
Intervention Type
Procedure
Intervention Name(s)
individualized substrate modification
Intervention Description
CPVI ablation and left atrial roof linear ablation first,then substrate mapping in sinus rhythm followed by individualized substrate modification.
Intervention Type
Procedure
Intervention Name(s)
stepwise ablation
Intervention Description
CPVI ablation,left atrial roof linear ablation,mitral isthmus linear ablation,complex fractionated atrial electrograms ablation step by step.
Primary Outcome Measure Information:
Title
atrial fibrillation free rate on or off antiarrhythmic drugs (AADs) after initial ablation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of participants with adverse event
Description
pericardial tamponade and thromboembolism event
Time Frame
1 year
Title
Prevalence of recurrent atrial flutter
Time Frame
1 year
Title
Proportion of pulmonary vein isolation
Time Frame
1 year
Title
Proportion of acute pulmonary vein re-connection
Time Frame
1 year
Title
Fluoroscopy exposure time
Time Frame
1 year
Title
Total ablation time
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinhua Wang, MD,PHD
Phone
862168385206
Email
ttwwxh@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinhua Wang, MD,PHD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Jiaotong University school of medicine,Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinhua Wang, MD,PHD
Phone
862168385206
Email
ttwwxh@126.com

12. IPD Sharing Statement

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

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