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THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study (STSF)

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ClinicalTrials.gov Identifier: NCT03963349
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Brief Summary:
Prospective, single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI).

Condition or disease
Paroxysmal Atrial Fibrillation

Detailed Description:

The purpose of this study is to measure the long term effectiveness,clinical benefit, and safety outcomes of catheter ablation with STSF and AI for paroxysmal atrial fibrillation (PAF) subjects up to 12-month follow-up.

Subject: Up to 250 PAF subjects will be included in the study data, representing all consecutive subjects having catheter ablation with AI guiding STSF and for the treatment of PAF at the site.

Primary endpoint: The primary endpoint is freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure.

Secondary endpoint : Acute success at 0.5hour CPVI (i.e. entrance block achieved in all veins, verified via an isoproterenol intravenous challenge)

  • Numbers of reconnected pulmonary veins (PV), with number and location of any gaps
  • Procedural efficiency measures(e.g. mapping time, ablation time, total procedure time, and fluid volume delivered via catheter.
  • AI values
  • Inter-Tag distances
  • Adverse events (Complications related to device or procedure)
  • Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year Clinical Study Sites: Shanghai General Hospital Study Duration: 12-month enrollment period, with follow-up at 3, 6 and 12 months after ablation, with a blanking period defined as the period within 90 days after the ablation.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Clinical Benefit, Long Term Effectiveness, and Safety Outcome of Paroxysmal Atrial Fibrillation Ablation Using THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index
Estimated Study Start Date : May 28, 2019
Estimated Primary Completion Date : May 6, 2021
Estimated Study Completion Date : September 22, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rate of freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure. [ Time Frame: 91-365 days ]
    Atrial tachyarrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.


Secondary Outcome Measures :
  1. Rate of acute success at 0.5hour CPVI [ Time Frame: 91-365 days ]
    Entrance block rate achieved by all pulmonary veins after 0.5hour waiting time and isoproterenol challenge after CPVI

  2. Numbers of reconnected pulmonary veins (PV), with number and location of any gaps [ Time Frame: 91-365 days ]
    Numbers of pulmonary veins recovered after 0.5hour waiting time and isoproterenol challenge after CPVI, and the location of recovery and number are also recorded

  3. Mapping time [ Time Frame: 91-365 days ]
    Procedural efficiency measures

  4. Contact force in grams [ Time Frame: 91-365 days ]
    Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation

  5. Rate of adverse events occurred [ Time Frame: 91-365 days ]
    Complications related to device or procedure

  6. Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year [ Time Frame: 91-365 days ]
    Rate of patients who are back to hospital and got hospitalized due to AF/AT/AFL recurrence or procedure-related reasons during 91 to 365 days after procedure

  7. Ablation time [ Time Frame: 91-365 days ]
    Procedural efficiency measures

  8. Total procedure time [ Time Frame: 91-365 days ]
    Procedural efficiency measures

  9. Fluid volume delivered via catheter [ Time Frame: 91-365 days ]
    Procedural efficiency measures

  10. Ablation times in seconds [ Time Frame: 91-365 days ]
    Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation

  11. Inter Tag in micrometers [ Time Frame: 91-365 days ]
    Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation

  12. RF ablation and fluoroscopy times in seconds [ Time Frame: 91-365 days ]
    Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PAF population patients
Criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. Patient has PAF eligible for AI-guided catheter ablation with an STSF catheter per standard of care assessment
  3. Able and willing to comply with all pre-, post- and follow-up testing and requirements
  4. Able to sign EC-approved informed consent form

Exclusion Criteria:

  1. AF is secondary to electrolyte imbalance, thyroid disease, or a reversible or non-cardiac cause
  2. Patient has AF episodes lasting longer than 7 days
  3. History of heart surgery, or any previous ablation for AF
  4. Myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within preceding 3 months
  5. Documented left atrial thrombus on imaging
  6. New York Heart Association (NYHA) class III or IV heart failure
  7. Hypertrophic obstructive cardiomyopathy
  8. Presence of implantable cardioverter defibrillator (ICD)
  9. Contraindication to isoproterenol
  10. Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator
  11. Women who are pregnant and/or breast feeding
  12. Enrollment in an investigational study evaluating another device, biologic, or drug

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): NCT03963349


Contacts
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Contact: Yue Wang, bacheler +86 15102120731 ywang454@its.jnj.com

Locations
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China, Shanghai
Shanghai General Hospital Not yet recruiting
Shanghai, Shanghai, China, 200080
Principal Investigator: Shaowen Liu, PhD         
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
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Principal Investigator: Shaowen Liu, PhD Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT03963349     History of Changes
Other Study ID Numbers: BWI-2018-01
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
URL: http://yoda.yale.edu.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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