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Ablation of Paroxysmal Atrial Fibrillation Using the Appropriate Contact Force in a Chinese Population

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ClinicalTrials.gov Identifier: NCT02493075
Recruitment Status : Unknown
Verified July 2015 by Chenyang Jiang, Sir Run Run Shaw Hospital.
Recruitment status was:  Recruiting
First Posted : July 9, 2015
Last Update Posted : July 9, 2015
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Chenyang Jiang, Sir Run Run Shaw Hospital

Brief Summary:
The objective of the study is:Phase I: To validate or otherwise determine the Chinese-specific appropriate contact force during PVI in PAF.Phase II: To evaluate the effectiveness and safety of ablation guided by the appropriate contact force.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Behavioral: The operator blinded to the contact force data or not. Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: Ablation of Paroxysmal Atrial Fibrillation Using the Appropriate Contact Force in a Chinese Population: A Prospective Randomized Single-center Trial
Study Start Date : March 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CF guided group
Ablation will be performed with smart-touch catheter.The operator will kown the real-time contact force (CF), ablation time, FTI, etc during the procedure.
Behavioral: The operator blinded to the contact force data or not.

CF guided group: ablation will be performed with the guidance of real-time CF, ablation time, FTI, etc. CF will be controlled in the range of "appropriate CF", which has been defined in phase I. Circumferential PV ablation will be performed orderly, "isolated segment"," acute reconnected segment ", and "unisolated segment" will be also identified as described in phase I.

Usual ablation group:

Operator will be blinded to CF data, the procedure performance is the same as described in phase I.


Active Comparator: Usual ablation group
Although we use the same catheter,operator will be blinded to CF data during the procedure.
Behavioral: The operator blinded to the contact force data or not.

CF guided group: ablation will be performed with the guidance of real-time CF, ablation time, FTI, etc. CF will be controlled in the range of "appropriate CF", which has been defined in phase I. Circumferential PV ablation will be performed orderly, "isolated segment"," acute reconnected segment ", and "unisolated segment" will be also identified as described in phase I.

Usual ablation group:

Operator will be blinded to CF data, the procedure performance is the same as described in phase I.





Primary Outcome Measures :
  1. Atrial fibrillation (AF) recurrence rate [ Time Frame: one year ]
    Patients will be followed up at 1, 3, 6, 9, 12months post ablation. Patients' experiences, 12-lead electrocardiograms (ECGs) and Holter monitoring (non-required at 1, 9 months) will be recorded to evaluate recurrence at each appointment (not including 1 and 3 month visit post procedure) and any visits when the patient experience symptoms that suggestive of arrhythmia. The first 3 months is considered as a blanking period.Recurrence is defined as AF/flutter/tachycardia, lasting longer than 30s, that documented by an ECG or Holter recording, or highly suggestive symptoms, after 3 months post-procedure.


Secondary Outcome Measures :
  1. Time Data related with procedure [ Time Frame: intraoperative ]
    Total procedure time, model reconstruction time, ablation time.

  2. Number of participants with Mortality and complications [ Time Frame: one year ]
    Safety Outcomes, contain mortality (death overall and procedure-related), vascular access complications (bleeding, hematoma, pseudoaneurysm, arteriovenous fistula), periprocedural events (stroke,cardiac tamponade, pulmonary embolism, deep vein thrombosis, other embolism, LA-esophageal fistula, Other fistula, pericardial effusion, PV stenosis, atrioventricular block, heart failure exacerbation, need for a pacemaker, phrenic nerve injury, acute coronary artery occlusion, valve injury).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 - 75 years
  • Symptomatic PAF refractory to at least one antiarrhythmic drug
  • Minimum of two episodes of recurrent self-terminating AF within prior 12 months and with latest documented episode within 6 months prior ablation procedure
  • First catheter ablation
  • Patient is able and willing to provide written informed consent.

Exclusion Criteria:

  • Persistent or long-standing persistent AF
  • >4 cardioversions in prior 12 months
  • Myocardial infarction(MI), coronary artery bypass grafting(CABG) or percutaneous coronary intervention (PCI) within preceding 3 months
  • Left atrial diameter >5.0 cm or <3.5 cm
  • Left ventricular ejection fraction by echocardiography <40%
  • New York Heart Association(NYHA)class III or IV
  • History of heart surgery or any previous ablation for AF
  • Intracardiac thrombus
  • Females who are pregnant or breast feeding.

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): NCT02493075


Contacts
Contact: Chenyang Jiang, MD +86 13857190051 jiangchenyang@gmail.com

Locations
China, Zhejiang
Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Chenyang Jiang, MD    +86 13857190051    jiangchenyang@gmail.com   
Sponsors and Collaborators
Sir Run Run Shaw Hospital
Biosense Webster, Inc.
Investigators
Principal Investigator: Chenyang Jiang, MD Sir Run Run Shaw Hospital

Responsible Party: Chenyang Jiang, chief physician, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT02493075     History of Changes
Other Study ID Numbers: IIs-304
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2015

Keywords provided by Chenyang Jiang, Sir Run Run Shaw Hospital:
atrial fibrillation
Catheter Ablation
contact force
Chinese-specific

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