Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05006456 |
| Other study ID # |
2021-novel |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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
