Atrial FibrillationPPC-AFNCT07044011
Precise Phenotyping Classification in Atrial Fibrillation
An observational study of Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 May 2030
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with atrial fibrillation.
Who may be able to join
- Patients diagnosed with atrial fibrillation.
- Voluntarily participated in the study and signed the informed consent form.
Who cannot join
None listed.
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
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
About this study
Official title: Study on Precise Phenotyping Classification in Atrial Fibrillation
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.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, classification
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation group | Patients with atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial arrhythmia
Atrial arrhythmia events lasting more than 30 seconds within 3 months to 1 year after catheter ablation of atrial fibrillation.
Measured: 1 year after catheter ablation of atrial fibrillation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ligang Ding, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044011
- Sponsor's protocol ID
- T2022-ZX016
- Acronym
- PPC-AF
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39210723Tzeis 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.
PubMed 38597857
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Precise Phenotyping Classification in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07044011
- Acronym / sponsor ID
- PPC-AF / T2022-ZX016
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, classification
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 29 Jun 2025 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation group | – | –Patients with atrial fibrillation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with atrial fibrillation.
Key inclusion criteria (2 listed)
- Patients diagnosed with atrial fibrillation.
- Voluntarily participated in the study and signed the informed consent form.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence of atrial arrhythmia
Time frame: 1 year after catheter ablation of atrial fibrillation.
Atrial arrhythmia events lasting more than 30 seconds within 3 months to 1 year after catheter ablation of atrial fibrillation.
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 29 Jun 2025.
- Background: PubMed 39210723Van 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.
- Results publication: PubMed 38597857Tzeis 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.
- Individual participant dataSharing planned: Undecided
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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.
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 China National Center for Cardiovascular Diseases 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 2 inclusion and 0 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: opening soon, as of the sponsor's last update on 29 Jun 2025. 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 Ligang Ding Professor, Doctor (+86 010-88322402, dlgang101@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial arrhythmia (time frame: 1 year after catheter ablation of atrial fibrillation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07044011, which also lists 2 linked publications.
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 29 Jun 2025.