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出境医 / 临床实验 / THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study (STSF)
THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study (STSF)
Study Description
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.
| 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 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 Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Other |
| Time Perspective: | Other |
| 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 |
| Actual Study Start Date : | June 24, 2019 |
| Estimated Primary Completion Date : | January 31, 2022 |
| Estimated Study Completion Date : | May 31, 2022 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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
Eligibility Criteria
| 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:
- Age 18 years or older
- Patient has PAF eligible for AI-guided catheter ablation with an STSF catheter per standard of care assessment
- Able and willing to comply with all pre-, post- and follow-up testing and requirements
- Able to sign EC-approved informed consent form
Exclusion Criteria:
- AF is secondary to electrolyte imbalance, thyroid disease, or a reversible or non-cardiac cause
- Patient has AF episodes lasting longer than 7 days
- History of heart surgery, or any previous ablation for AF
- Myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within preceding 3 months
- Documented left atrial thrombus on imaging
- New York Heart Association (NYHA) class III or IV heart failure
- Hypertrophic obstructive cardiomyopathy
- Presence of implantable cardioverter defibrillator (ICD)
- Contraindication to isoproterenol
- Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator
- Women who are pregnant and/or breast feeding
- Enrollment in an investigational study evaluating another device, biologic, or drug
Contacts and Locations
Contacts
| Contact: Yue Wang, bacheler | +86 15102120731 | ywang454@its.jnj.com |
Locations
| China, Shanghai | |
| Shanghai General Hospital | Recruiting |
| Shanghai, Shanghai, China, 200080 | |
| Principal Investigator: Shaowen Liu, PhD | |
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
| Principal Investigator: | Shaowen Liu, PhD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | May 6, 2019 | ||||||
| First Posted Date | May 24, 2019 | ||||||
| Last Update Posted Date | November 3, 2020 | ||||||
| Actual Study Start Date | June 24, 2019 | ||||||
| Estimated Primary Completion Date | January 31, 2022 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures |
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.
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| Change History | |||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| 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)
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| Study Type | Observational [Patient Registry] | ||||||
| Study Design | Observational Model: Other Time Perspective: Other |
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| 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 | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment |
150 | ||||||
| Original Estimated Enrollment |
250 | ||||||
| Estimated Study Completion Date | May 31, 2022 | ||||||
| Estimated Primary Completion Date | January 31, 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Biosense Webster, Inc. | ||||||
| Study Sponsor | Biosense Webster, Inc. | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | Biosense Webster, Inc. | ||||||
| Verification Date | November 2020 | ||||||
