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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Catheter ablation

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

• Study Contact: Name: Xin Du, MD, PhD; Phone Number: 086-010-84005363; Email: duxinheart@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population consists of adults age 18 years or older with symptomatic Paroxysmal and Persistent Atrial Fibrillation who are candidates for ablation

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
Cohort 2; Cohort 2 consists of 2000 subjects who undergoing catheter ablation using QDOT or HELIOSTAR catheter.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
First pass isolation rate	First pass isolation rate for STSF/QDOT before adenosine/isoproterenol challenge	During ablation procedure
Single-Shot-Success (SSS) rate	Single-Shot-Success (SSS) rate for HELIOSTAR per PV/ per patient before adenosine/isoproterenol challenge	During ablation procedure
Time to isolation (TTI)	Time to isolation (TTI) for HELIOSTAR per PV/ per patient before adenosine/isoproterenol challenge	During ablation procedure
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
Procedure time	Including total procedure time，LA time，RF application time per circle ，needle time in transseptal puncture	During ablation procedure
Mapping points	mapping points	During ablation procedure
fluid volume	fluid volume delivered via catheter	During ablation procedure

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: Johnson & Johnson; Heart Health Research Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): September 30, 2025
• Study Completion (ANTICIPATED): January 30, 2026

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: August 8, 2021
• First Posted (ACTUAL): August 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2021-novel

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No