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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03963349
Recruitment Status : Active, not recruiting
First Posted : May 24, 2019
Last Update Posted : December 28, 2022
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Tracking Information
First Submitted Date May 6, 2019
First Posted Date May 24, 2019
Last Update Posted Date December 28, 2022
Actual Study Start Date June 24, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2019)
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.
Original Primary Outcome Measures
 (submitted: May 23, 2019)
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.
Change History
Current Secondary Outcome Measures
 (submitted: June 4, 2019)
  • 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
  • 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
  • Mapping time [ Time Frame: 91-365 days ]
    Procedural efficiency measures
  • 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
  • Rate of adverse events occurred [ Time Frame: 91-365 days ]
    Complications related to device or procedure
  • 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
  • Ablation time [ Time Frame: 91-365 days ]
    Procedural efficiency measures
  • Total procedure time [ Time Frame: 91-365 days ]
    Procedural efficiency measures
  • Fluid volume delivered via catheter [ Time Frame: 91-365 days ]
    Procedural efficiency measures
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: May 23, 2019)
  • Acute success at 0.5hour CPVI [ Time Frame: 91-365 days ]
  • Numbers of reconnected pulmonary veins (PV), with number and location of any gaps [ Time Frame: 91-365 days ]
  • Mapping time [ Time Frame: 91-365 days ]
    Procedural efficiency measures
  • physiological parameter of the Carto 3 which is background data generated during operation [ Time Frame: 91-365 days ]
    AI values
  • Inter-Tag distances [ Time Frame: 91-365 days ]
  • Adverse events [ Time Frame: 91-365 days ]
    Complications related to device or procedure
  • Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year [ Time Frame: 91-365 days ]
  • Ablation time [ Time Frame: 91-365 days ]
    Procedural efficiency measures
  • Total procedure time [ Time Frame: 91-365 days ]
    Procedural efficiency measures
  • Fluid volume delivered via catheter [ Time Frame: 91-365 days ]
    Procedural efficiency measures
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study
Official Title Clinical Benefit, Long Term Effectiveness, and Safety Outcome of Paroxysmal Atrial Fibrillation Ablation Using THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index
Brief Summary A 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). Prospectively or retrospectively record 150 eligible subjects since 1st Jan 2019 to evaluate effectiveness and safety of STSF with AI.
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 150 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: 18-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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population PAF population patients
Condition Paroxysmal Atrial Fibrillation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 20, 2020)
150
Original Estimated Enrollment
 (submitted: May 23, 2019)
250
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03963349
Other Study ID Numbers BWI-2018-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Current Responsible Party Biosense Webster, Inc.
Original Responsible Party Same as current
Current Study Sponsor Biosense Webster, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Shaowen Liu, PhD Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
PRS Account Biosense Webster, Inc.
Verification Date December 2022