Real-world Experience of Catheter Ablation Using Novel Ablation Technologies for the Treatment of Atrial Fibrillation
NCT ID: NCT05006456
Last Updated: 2021-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
4000 participants
OBSERVATIONAL
2022-01-01
2026-01-30
Brief Summary
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Detailed Description
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1. Primary endpoint 1.1 The primary effectiveness endpoint is the percent of subjects who are freedom from atrial arrhythmia (any documented AF, atrial tachycardia (AT), or atrial flutter (AFL) episode of ≥30 seconds by heart rhythm monitoring patch, ECG, or Holter recording) from days 91 to 365 post ablation, with or without the use of any anti-arrhythmic drugs (AADs).
1.2 The primary safety endpoint is the incidence of primary adverse events (PAEs), defined as procedure- or device-related serious adverse events occurred within 7 days of the procedure.
2. Secondary endpoint 2.1 Freedom from documented AF/AT/ AFL lasting≥30 seconds from days 91 to 365 post ablation without AADs 2.2 Acute procedural success of PVI, confirmed by entrance block in all pulmonary veins after adenosine and/or isoproterenol challenge 2.3 First pass isolation rate for STSF/QDOT and Single-Shot-Success (SSS) rate for HELIOSTAR per PV/ per patient before adenosine/isoproterenol challenge 2.4 Time to isolation (TTI) for HELIOSTAR per PV/ per patient before adenosine/isoproterenol challenge 2.5 Numbers of acute pulmonary vein (PV) reconnection after waiting/challenge, with number and location of any gaps in each patient 2.6 Procedural efficiency parameters \[total procedure time, mapping time and points, LA time, fluoroscopy time and dose, RF application time per circle (left and right wide area circumferential ablation) and in total, needle time in transseptal puncture, and fluid volume delivered via catheter\]
3. Follow up Follow-up visits will be scheduled at 3, 6, 9 and 12 months after the index ablation procedure 3.1 Subject baseline information: age, sex, height, weight, medical and heart surgery history, left ventricular ejection fraction (LVEF), left atrial dimension, left atrium volume, New York Heart Association (NYHA) Class, physical activity (IPAQ-S-CBaecke et al), depression (PHQ-9) and anxiety (PHQ-GAD-7), AF symptoms/duration, quality of life (AFEQT/EQ-5D), concomitant medications, LAA detection methods (CT/TEE/ICE), and results of laboratory tests 3.2 Peri-procedural data :
* Procedural and ablation data: total procedure time, LA time, fluoroscopy time and dose, RF application time per circle
* Ablation strategies: Ablation sites and the AI values for each ablation line
* Acute success data
* VISITAG® source database
* Postprocedural complications/adverse events: device- and/or procedure-related serious adverse events (SAEs\]
* Periprocedural medications: anticoagulants, AADs, and sedation medicine
* Duration of hospital stay. 3.3 Follow-up data
* Patient information（details）
* Concomitant medications
* Any documented AF recurrence in 12-lead ECG, Holter, or any qualified monitoring equipment.
* Re-ablation and ablation sites (if applicable)
* Emergency room visit or hospitalization due to arrhythmia recurrence or procedure-related complications
* New onset medical conditions
* Adverse events
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Cohort 1 consists of 2000 subjects undergoing catheter ablation with STSF catheter, in which AI is used to guide the ablation lesion creation.
Catheter ablation
Subjects will undergo catheter ablation using the new technologies, including THERMOCOOL SMARTTOUCH® SF catheter with Visitag SURPOINT, QDOT catheter and HELIOSTAR catheter when they are used in conjunction with Carto system for AF ablations.
Cohort 2
Cohort 2 consists of 2000 subjects who undergoing catheter ablation using QDOT or HELIOSTAR catheter.
Catheter ablation
Subjects will undergo catheter ablation using the new technologies, including THERMOCOOL SMARTTOUCH® SF catheter with Visitag SURPOINT, QDOT catheter and HELIOSTAR catheter when they are used in conjunction with Carto system for AF ablations.
Interventions
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Catheter ablation
Subjects will undergo catheter ablation using the new technologies, including THERMOCOOL SMARTTOUCH® SF catheter with Visitag SURPOINT, QDOT catheter and HELIOSTAR catheter when they are used in conjunction with Carto system for AF ablations.
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent to participate in the study
* Drug refractory symptomatic paroxysmal AF or symptomatic persistent AF for less than 12 months who, in the opinion of the investigator, are candidates for catheter ablation per standard-of-care
* Undergoing AF ablation for the first time
* THERMOCOOL SMARTTOUCH® SF catheter with Visitag SURPOINT or newer technologies (e.g. QDOT, HELIOSTAR) are used in conjunction with Carto system in the ablation procedure
Exclusion Criteria
* The subject has a life expectancy of less than 12 months
* Severe valvular heart disease
* The subject has been enrolled in another investigational study evaluating a medical device or a drug.
18 Years
ALL
No
Sponsors
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Heart Health Research Center
OTHER
Johnson & Johnson
INDUSTRY
Beijing Anzhen Hospital
OTHER
Responsible Party
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Chang sheng Ma
Prof.
Central Contacts
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Other Identifiers
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2021-novel
Identifier Type: -
Identifier Source: org_study_id