NCT05006456

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

3.7 years

First QC Date

July 14, 2021

Last Update Submit

December 6, 2021

Conditions

Paroxysmal Atrial FibrillationPersistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • AF recurrence

    12 month

  • Acute procedural success of PVI

    During ablation procedure

  • First pass isolation rate

    During ablation procedure

  • Single-Shot-Success (SSS) rate

    During ablation procedure

  • Time to isolation (TTI)

    During ablation procedure

  • +4 more secondary outcomes

Study Arms (2)

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

Cohort 2

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

Device: Catheter ablation

Interventions

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.

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Central Study Contacts

Xin Du, MD, PhD

CONTACT

086-010-84005363duxinheart@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 14, 2021

First Posted

August 16, 2021

Study Start

January 1, 2022

Primary Completion

September 30, 2025

Study Completion

January 30, 2026

Last Updated

December 20, 2021

Record last verified: 2021-12