Health TrialsbyHealthPanel

Study of the Closed-loop Treatment Concept of Atrial Fibrillation in the Atrial Fibrillation Population

ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorShanghai 10th People's Hospital

About this trial

This study aims to evaluate the concept of closed-loop treatment of atrial fibrillation for the optimization of the treatment strategy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

atrial fibrillation patients；Ability to act autonomously, understand and sign informed consent；

Disqualifiers

none（All patients with atrial fibrillation were enrolled in this study indiscriminately and followed up）

Trial population

Atrial fibrillation patients in North Shanghai area.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radiofrequency ablation

    Procedure/Surgery

    Combined use of radiofrequency ablation, cryoablation, left bundle branch pacing, and left atrial appendage closure according to the actual situation of the patient.

Treatment groups

5,000 Participants
are divided into 3 treatment groups
Group A: Closed-loop Group1 intervention
Group B: No Closed-loop Group0 interventions
Group C: Exchange Group1 intervention

Trial outcomes

Primary outcomes

1

Atrial fibrillation recurrence

The recurrence of atrial fibrillation and the degree of burden of atrial fibrillation in patients.

Time frame
2 years
2

Heart failure

Degree of heart failure (including EF%, NYHA score, etc.)

Time frame
5 years
3

Stroke

stroke attack(Check for new cerebral infarction by MRI）

Time frame
5 years

Secondary outcomes

1

bleeding

major bleeding event

Time frame
2 years
2

Cardiovascular MACE events

Cardiovascular MACE events

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai 10th People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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