Atrial FibrillationCONTROL-AFNCT05311137
Study of the Closed-loop Treatment Concept of Atrial Fibrillation in the Atrial Fibrillation Population
An observational study of Atrial Fibrillation, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
This study aims to evaluate the concept of closed-loop treatment of atrial fibrillation for the optimization of the treatment strategy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Jan 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- Adult, Older adult
Study population: Atrial fibrillation patients in North Shanghai area.
Who may be able to join
- atrial fibrillation patients；Ability to act autonomously, understand and sign informed consent；
Who cannot join
- none（All patients with atrial fibrillation were enrolled in this study indiscriminately and followed up）
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Jun Zhang, M.D., +8615000420881, zhangjun_njmu2011@163.com
About this study
Official title: Application of the Closed-loop Treatment Concept of Atrial Fibrillation in the Atrial Fibrillation Population in the Northern Shanghai Community
This study aims to evaluate the concept of closed-loop treatment of atrial fibrillation for the optimization of the treatment strategy.
Read the detailed description
This study aims to evaluate the concept of closed-loop treatment of atrial fibrillation for the optimization of the treatment strategy, the improvement of disease outcome and the economic value of the atrial fibrillation population in the northern Shanghai community. Improve the disease cognition of patients with atrial fibrillation, and promote the development of the concept of closed-loop treatment of atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Radiofrequency ablation
- Keywords
- atrial fibrillation；closed-loop treatment；
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
Also called cryoablation;, left bundle branch pacing;, left atrial appendage occlusion;
Combined use of radiofrequency ablation, cryoablation, left bundle branch pacing, and left atrial appendage closure according to the actual situation of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop Group | Groups of Patients Adhering to Closed-Loop Therapy. Receives: Procedure: Radiofrequency ablation | |
| No Closed-loop Group | Patients who have not undergone closed-loop treatment or patients who have not undergone standard surgery and medication. | |
| Exchange Group | Groups of patients with delayed compliance with closed-loop therapy for atrial fibrillation. Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation recurrence
The recurrence of atrial fibrillation and the degree of burden of atrial fibrillation in patients.
Measured: 2 years
Heart failure
Degree of heart failure (including EF%, NYHA score, etc.)
Measured: 5 years
Stroke
stroke attack(Check for new cerebral infarction by MRI）
Measured: 5 years
Secondary outcomes (2)
bleeding
major bleeding event
Measured: 2 years
Cardiovascular MACE events
Cardiovascular MACE events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 May 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- WeiYa Xu, PhD, Study chair, No. 301 Yanchang Middle Road, Jing'an District, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311137
- Sponsor's protocol ID
- CONTROL-AF
- Acronym
- CONTROL-AF
- Status last verified
- May 2022
- First submitted
- 28 Mar 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Closed-loop Treatment Concept of Atrial Fibrillation in the Atrial Fibrillation Population in the Northern Shanghai Community
- ClinicalTrials.gov ID
- NCT05311137
- Acronym / sponsor ID
- CONTROL-AF / CONTROL-AF
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation；closed-loop treatment；
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 5 Apr 2022 (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.
This study aims to evaluate the concept of closed-loop treatment of atrial fibrillation for the optimization of the treatment strategy.
Detailed description
This study aims to evaluate the concept of closed-loop treatment of atrial fibrillation for the optimization of the treatment strategy, the improvement of disease outcome and the economic value of the atrial fibrillation population in the northern Shanghai community. Improve the disease cognition of patients with atrial fibrillation, and promote the development of the concept of closed-loop treatment of atrial fibrillation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Closed-loop Group | – | Procedure: Radiofrequency ablationGroups of Patients Adhering to Closed-Loop Therapy. |
| No Closed-loop Group | – | –Patients who have not undergone closed-loop treatment or patients who have not undergone standard surgery and medication. |
| Exchange Group | – | Procedure: Radiofrequency ablationGroups of patients with delayed compliance with closed-loop therapy for atrial fibrillation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Atrial fibrillation patients in North Shanghai area.
Key inclusion criteria (1 listed)
- atrial fibrillation patients；Ability to act autonomously, understand and sign informed consent；
Key exclusion criteria (1 listed)
- none（All patients with atrial fibrillation were enrolled in this study indiscriminately and followed up）
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 |
|---|---|---|
| Radiofrequency ablationAlso: cryoablation;, left bundle branch pacing;, left atrial appendage occlusion;Combined use of radiofrequency ablation, cryoablation, left bundle branch pacing, and left atrial appendage closure according to the actual situation of the patient. | Procedure or surgery | Closed-loop Group, Exchange Group |
Primary outcome
Atrial fibrillation recurrence
Time frame: 2 years
The recurrence of atrial fibrillation and the degree of burden of atrial fibrillation in patients.
Heart failure
Time frame: 5 years
Degree of heart failure (including EF%, NYHA score, etc.)
Stroke
Time frame: 5 years
stroke attack(Check for new cerebral infarction by MRI）
2 secondary outcomes
bleeding
Time frame: 2 years
Cardiovascular MACE events
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
WeiYa Xu, PhD study chair
No. 301 Yanchang Middle Road, Jing'an District, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Shanghai 10th People's Hospital at 1 site in China.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DongDong Zhao, PhD (+86 18917684008, zhaodd@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation recurrence (time frame: 2 years). The study lists 3 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 24 May 2022.