NCT07044011

Brief Summary

This study aims to integrate multi-omics data (genomics, imaging, serology, etc.) to achieve precise phenotyping classification for atrial fibrillation (AF) patients and explore personalized rhythm control strategies. By enrolling over 1,000 AF patients, we will collect genomic data including GWAS and single-cell sequencing, combined with cardiac MRI, CT, echocardiography imaging, and serum biomarkers, to uncover AF pathological mechanisms and recurrence risks at molecular and structural levels. Machine learning and AI algorithms will be employed to develop AF phenotypic classification models, which will be validated across multiple centers to assess their accuracy and reliability in predicting AF recurrence and therapeutic responses. Furthermore, clinical trials will evaluate the efficacy of oral dronedarone hydrochloride tablets and intravenous nicorandil hydrochloride in preventing post-catheter ablation recurrence and their safety/effectiveness in early cardioversion. Finally, based on advanced phenotyping results, we will establish personalized rhythm control strategies integrating pharmacotherapy, catheter ablation, and lifestyle interventions to optimize AF management.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
50mo left

Started Aug 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress16%
Aug 2025May 2030

First Submitted

Initial submission to the registry

June 9, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2030

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

4.8 years

First QC Date

June 9, 2025

Last Update Submit

June 23, 2025

Conditions

Keywords

atrial fibrillation, classification

Outcome Measures

Primary Outcomes (1)

  • Recurrence of atrial arrhythmia

    Atrial arrhythmia events lasting more than 30 seconds within 3 months to 1 year after catheter ablation of atrial fibrillation.

    1 year after catheter ablation of atrial fibrillation.

Study Arms (1)

Atrial fibrillation group

Patients with atrial fibrillation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with atrial fibrillation.

You may qualify if:

  • Patients diagnosed with atrial fibrillation.
  • Voluntarily participated in the study and signed the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (2)

  • Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.

    PMID: 39210723BACKGROUND
  • Tzeis S, Gerstenfeld EP, Kalman J, Saad EB, Shamloo AS, Andrade JG, Barbhaiya CR, Baykaner T, Boveda S, Calkins H, Chan NY, Chen M, Chen SA, Dagres N, Damiano RJ, De Potter T, Deisenhofer I, Derval N, Di Biase L, Duytschaever M, Dyrda K, Hindricks G, Hocini M, Kim YH, la Meir M, Merino JL, Michaud GF, Natale A, Nault I, Nava S, Nitta T, O'Neill M, Pak HN, Piccini JP, Purerfellner H, Reichlin T, Saenz LC, Sanders P, Schilling R, Schmidt B, Supple GE, Thomas KL, Tondo C, Verma A, Wan EY. 2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2024 Sep;21(9):e31-e149. doi: 10.1016/j.hrthm.2024.03.017. Epub 2024 Apr 8.

    PMID: 38597857BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ligang Ding Professor, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 29, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

May 31, 2030

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations