Atrial FibrillationNCT06552845
Consistency of LGE-MRI Fibrosis and EAM Low-voltage Area
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: 1. Assess the consistency of LGE-MRI bi-atrial fibrosis and electroanatomical mapping of bi-atrial low voltage region 2. To evaluate the electroanatomical characteristics of different types of fibrosis (dense fibrosis, patchy fibrosis, etc.) in different locations of the left and right atrium; 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- LGE-MRI Scan
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult AF patients who are planned to receive catheter ablation and have no contraindications of LGE-MRI
Who may be able to join
- Adult patients (≥18 years old) who are willing to participate in this study and can sign informed consent;
- Atrial fibrillation was diagnosed and catheter ablation was proposed
Who cannot join
- Left atrial thrombus or left atrial appendage thrombus;
- Severe chronic obstructive pulmonary disease (FEV1/ FVC<70%, FEV1<50% predicted value);
- Absolute contraindications of anticoagulation therapy;
- Currently pregnant;
- Contraindications for LGE-MRI (claustrophobia, pacemaker implantation, eGFR<30ml/min for renal insufficiency, severe obesity, pregnancy, gadolinium chelating agent allergy, etc.);
- refuse to participate in the study;
- other physical or mental incapacity to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037
Zhe Zheng, MD, PhD, +86 88396051, zhengzhe@fuwai.com
About this study
Official title: Exploratory Study of Consistency of Bi-Atrial Fibrosis Detected by Late Gadolinium Enhancement Magnetic Resonance Imaging and Low Voltage Area of Electroanatomic Mapping
This study aims to:
- Assess the consistency of LGE-MRI bi-atrial fibrosis and electroanatomical mapping of bi-atrial low voltage region
- To evaluate the electroanatomical characteristics of different types of fibrosis (dense fibrosis, patchy fibrosis, etc.) in different locations of the left and right atrium;
- To explore the correlation between preoperative and postoperative bi-atrial fibrosis and long-term recurrence in patients with atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- LGE-MRI Scan
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGE-MRI ScanDiagnostic test
Participants will receive LGE-MRI scan before catheter ablation and 3 months after catheter ablation
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | Inclusion Criteria
1. Adult patients (≥18 years old) who are willing to participate in this study and can sign informed consent;
2. Atrial fibrillation was diagnosed and catheter ablation was proposed Exclusion criteria
a) Left atrial thrombus or left atrial appendage thrombus; b) Severe chronic obstructive pulmonary disease (FEV1/ FVC<70%, FEV1<50% predicted value); c) Absolute contraindications of anticoagulation therapy; d) Currently pregnant; e) Contraindications for LGE-MRI (claustrophobia, pacemaker implantation, eGFR<30ml/min for renal insufficiency, severe obesity, pregnancy, gadolinium chelating agent allergy, etc.); f) refuse to participate in the study; g) other physical or mental incapacity to participate in the study. Receives: Diagnostic Test: LGE-MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency of LGE-MRI fibrosis and EAM low-voltage area
Use Registration to match the corresponding spatial points of LGE-MRI and EAM。Each spatial points will contain two types of status(Fibrosis: Yes/No, Low-voltage area: Yes/No). Chi-square test will be used to assess the consistency of fibrosis and low-voltage area.
Measured: Baseline (at recruit time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552845
- Sponsor's protocol ID
- 2023-2223
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared under the permission of primary investigator
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Consistency of Bi-Atrial Fibrosis Detected by Late Gadolinium Enhancement Magnetic Resonance Imaging and Low Voltage Area of Electroanatomic Mapping
- ClinicalTrials.gov ID
- NCT06552845
- Acronym / sponsor ID
- 2023-2223
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Aug 2024 (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:
- Assess the consistency of LGE-MRI bi-atrial fibrosis and electroanatomical mapping of bi-atrial low voltage region
- To evaluate the electroanatomical characteristics of different types of fibrosis (dense fibrosis, patchy fibrosis, etc.) in different locations of the left and right atrium;
- To explore the correlation between preoperative and postoperative bi-atrial fibrosis and long-term recurrence in patients with atrial fibrillation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | Diagnostic Test: LGE-MRI ScanInclusion Criteria 1. Adult patients (≥18 years old) who are willing to participate in this study and can sign informed consent; 2. Atrial fibrillation was diagnosed and catheter ablation was proposed Exclusion criteria a) Left atrial thrombus or left atrial appendage thrombus; b) Severe chronic obstructive pulmonary disease (FEV1/ FVC<70%, FEV1<50% predicted value); c) Absolute contraindications of anticoagulation therapy; d) Currently pregnant; e) Contraindications for LGE-MRI (claustrophobia, pacemaker implantation, eGFR<30ml/min for renal insufficiency, severe obesity, pregnancy, gadolinium chelating agent allergy, etc.); f) refuse to participate in the study; g) other physical or mental incapacity to participate in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult AF patients who are planned to receive catheter ablation and have no contraindications of LGE-MRI
Key inclusion criteria (2 listed)
- Adult patients (≥18 years old) who are willing to participate in this study and can sign informed consent;
- Atrial fibrillation was diagnosed and catheter ablation was proposed
Key exclusion criteria (7 listed)
- Left atrial thrombus or left atrial appendage thrombus;
- Severe chronic obstructive pulmonary disease (FEV1/ FVC<70%, FEV1<50% predicted value);
- Absolute contraindications of anticoagulation therapy;
- Currently pregnant;
- Contraindications for LGE-MRI (claustrophobia, pacemaker implantation, eGFR<30ml/min for renal insufficiency, severe obesity, pregnancy, gadolinium chelating agent allergy, etc.);
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 |
|---|---|---|
| LGE-MRI ScanParticipants will receive LGE-MRI scan before catheter ablation and 3 months after catheter ablation | Diagnostic test | Observational Group |
Primary outcome
Consistency of LGE-MRI fibrosis and EAM low-voltage area
Time frame: Baseline (at recruit time point)
Use Registration to match the corresponding spatial points of LGE-MRI and EAM。Each spatial points will contain two types of status(Fibrosis: Yes/No, Low-voltage area: Yes/No). Chi-square test will be used to assess the consistency of fibrosis and low-voltage area.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: Undecided. IPD will be shared under the permission of primary investigator
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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. This study is not recruiting at the moment.
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 7 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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency of LGE-MRI fibrosis and EAM low-voltage area (time frame: Baseline (at recruit time point)). 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 14 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.