Real-world Experience of Catheter Ablation Using Novel Ablation Technologies for the Treatment of Atrial Fibrillation (NOVEL AF)

Capital Medical University

Status: Not yet enrolling

Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Treatments: Device: Catheter ablation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05006456

2021-novel

Details and patient eligibility

About

The primary purpose of this registry is to obtain real-world clinical experience for the latest and future ablation technologies when used in conjunction with the Carto system in the treatment of patients with atrial fibrillation (AF) in Asian countries. The ablation technologies include THERMOCOOL SMARTTOUCH® SF (STSF) catheter with Ablation Index (AI) /Visitag SURPOINT, QDOT catheter, and HELIOSTAR catheter. Additional new ablation and/or mapping technologies may be included in future when they become available in local markets.

Full description

Novel-AF study is a prospective, non-randomized, multi-center, longitudinal study.

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

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 years or older
• 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

• Women of childbearing potential who are, or plan to become, pregnant during the time of the study
• 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.

Trial design

4,000 participants in 2 patient groups

Cohort 1

Description:

Cohort 1 consists of 2000 subjects undergoing catheter ablation with STSF catheter, in which AI is used to guide the ablation lesion creation.

Treatment:

Device: Catheter ablation

Cohort 2

Description:

Cohort 2 consists of 2000 subjects who undergoing catheter ablation using QDOT or HELIOSTAR catheter.

Treatment:

Device: Catheter ablation