Paroxysmal Atrial FibrillationNOVEL AFNCT05006456
Real-world Experience of Catheter Ablation Using Novel Ablation Technologies for the Treatment of Atrial Fibrillation
An observational study of Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Beijing Anzhen Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- Catheter ablation
- Type of treatment
- Medical device
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 30 Jan 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population consists of adults age 18 years or older with symptomatic Paroxysmal and Persistent Atrial Fibrillation who are candidates for ablation
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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)
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.
Read the detailed description
Novel-AF study is a prospective, non-randomized, multi-center, longitudinal study.
- 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.
- 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]
- 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
- Being tested
- Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Catheter ablation | |
| Cohort 2 | Cohort 2 consists of 2000 subjects who undergoing catheter ablation using QDOT or HELIOSTAR catheter. Receives: Device: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 7 days
Secondary outcomes (9)
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.
Measured: 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
Measured: During ablation procedure
First pass isolation rate
First pass isolation rate for STSF/QDOT before adenosine/isoproterenol challenge
Measured: During ablation procedure
Single-Shot-Success (SSS) rate
Single-Shot-Success (SSS) rate for HELIOSTAR per PV/ per patient before adenosine/isoproterenol challenge
Measured: During ablation procedure
Time to isolation (TTI)
Time to isolation (TTI) for HELIOSTAR per PV/ per patient before adenosine/isoproterenol challenge
Measured: 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
Measured: During ablation procedure
Procedure time
Including total procedure time，LA time，RF application time per circle ，needle time in transseptal puncture
Measured: During ablation procedure
Mapping points
mapping points
Measured: During ablation procedure
fluid volume
fluid volume delivered via catheter
Measured: During ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Jan 2022 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Health Research Center, Johnson & Johnson
- Responsible party
- Principal investigator, Chang sheng Ma, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006456
- Sponsor's protocol ID
- 2021-novel
- Acronym
- NOVEL AF
- Status last verified
- Dec 2021
- First submitted
- 14 Jul 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05006456
- Acronym / sponsor ID
- NOVEL AF / 2021-novel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Heart Health Research Center, Johnson & Johnson
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Novel-AF study is a prospective, non-randomized, multi-center, longitudinal study.
- 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.
- 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]
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: Catheter ablationCohort 1 consists of 2000 subjects undergoing catheter ablation with STSF catheter, in which AI is used to guide the ablation lesion creation. |
| Cohort 2 | – | Device: Catheter ablationCohort 2 consists of 2000 subjects who undergoing catheter ablation using QDOT or HELIOSTAR catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consists of adults age 18 years or older with symptomatic Paroxysmal and Persistent Atrial Fibrillation who are candidates for ablation
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablationSubjects 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. | Device | Cohort 1, Cohort 2 |
Primary outcome
The percent of subjects who are freedom from atrial arrhythmia (any documented AF, atrial tachycardia (AT), or atrial flutter (AFL) episode.
Time frame: 12 months
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).
Incidence of primary adverse events (PAEs)
Time frame: 7 days
PAEs defined as procedure- or device-related serious adverse events occurred within 7 days of the procedure
9 secondary outcomes
AF recurrence
Time frame: 12 month
Acute procedural success of PVI
Time frame: During ablation procedure
First pass isolation rate
Time frame: During ablation procedure
Single-Shot-Success (SSS) rate
Time frame: During ablation procedure
Time to isolation (TTI)
Time frame: During ablation procedure
Proportion of acute pulmonary vein (PV) reconnection
Time frame: During ablation procedure
Procedure time
Time frame: During ablation procedure
Mapping points
Time frame: During ablation procedure
fluid volume
Time frame: During ablation procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Beijing Anzhen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Du, MD, PhD (086-010-84005363, duxinheart@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent of subjects who are freedom from atrial arrhythmia (any documented AF, atrial tachycardia (AT), or atrial flutter (AFL) episode. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.