Real-world Experience of Catheter Ablation Using Novel Ablation Technologies for the Treatment of Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

— NOVEL AF  

Official title:

Real-world Experience of Catheter Ablation Using Novel Ablation Technologies Associated With the Carto System for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation (NOVEL AF)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05006456
• Other study ID #: 2021-novel
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: January 30, 2026

Study information

• Verified date: December 2021
• Source: Beijing Anzhen Hospital
• Contact: Xin Du, MD, PhD
• Phone: 086-010-84005363
• Email: duxinheart[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: January 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Heart Health Research Center, Johnson & Johnson

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent of subjects who are freedom from atrial arrhythmia (any documented AF, atrial tachycardia (AT), or atrial flutter (AFL) episode.	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).	12 months
Primary	Incidence of primary adverse events (PAEs)	PAEs defined as procedure- or device-related serious adverse events occurred within 7 days of the procedure	7 days
Secondary	AF recurrence	Freedom from documented AF/AT/ AFL lasting=30 seconds recording post ablation from days 91 to 365 without AADs, monitoring with ECG; Holter; Heart Rhythm Monitoring Patch;Dual/ CRT Pacer or ICD.	12 month
Secondary	Acute procedural success of PVI	Acute procedural success of PVI, confirmed by entrance block in all pulmonary veins after adenosine and/or isoproterenol challenge	During ablation procedure
Secondary	First pass isolation rate	First pass isolation rate for STSF/QDOT before adenosine/isoproterenol challenge	During ablation procedure
Secondary	Single-Shot-Success (SSS) rate	Single-Shot-Success (SSS) rate for HELIOSTAR per PV/ per patient before adenosine/isoproterenol challenge	During ablation procedure
Secondary	Time to isolation (TTI)	Time to isolation (TTI) for HELIOSTAR per PV/ per patient before adenosine/isoproterenol challenge	During ablation procedure
Secondary	Proportion of acute pulmonary vein (PV) reconnection	Proportion of acute pulmonary vein (PV) reconnection, with number and location of any gaps in each patient	During ablation procedure
Secondary	Procedure time	Including total procedure time,LA time,RF application time per circle ,needle time in transseptal puncture	During ablation procedure
Secondary	Mapping points	mapping points	During ablation procedure
Secondary	fluid volume	fluid volume delivered via catheter	During ablation procedure