Persistent Atrial FibrillationNCT05227586
Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation With Right Atrial Enlargement
An observational study of Persistent Atrial Fibrillation and Right Atrial Enlargement, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This is retrospective cohort study testing whether patients with persistent atrial fibrillation and right atrial enlargement may benefit from adjunctive right atrial ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Right Atrial Enlargement
- What is being tested?
- Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation and Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation + right atrial driver ablation
- Type of treatment
- Surgery or procedure
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 20 Jan 2022
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: The study population enrolled were patients with persistent atrial fibrillation and right atrial enlargement received catheter ablation for the first time in our institution. Patients with a history of catheter ablation, valvular heart disease, hypertrophic or dilated cardiomyopathy and unavailable of follow-up data were excluded
Who may be able to join
- Aged 18 to 80 years old;
- Persistent AF with right atrial enlargement;
- Nonresponse or intolerance to ≥1 antiarrhythmic drug.
Who cannot join
- History of catheter ablation;
- valvular heart disease;
- hypertrophic cardiomyopathy or dilated cardiomyopathy;
- Without follow-up data
Trial locations and contacts
1 site in 1 country.
About this study
This is retrospective cohort study testing whether patients with persistent atrial fibrillation and right atrial enlargement may benefit from adjunctive right atrial ablation.
Read the detailed description
This is retrospective cohort study testing whether patients with persistent atrial fibrillation and right atrial enlargement may benefit from adjunctive RA ablation.
We enrolled 65 patients with persistent atrial fibrillation and right atrial enlargement received adjunctive right atrial ablation. These patients were 1:2 match with 130 patients received left atrial ablation only. Atrial fibrillation recurrence rate and other paremeters were analyzed to evaluate the efficacy of adjunctive right atrial ablation in this subset of patients.
- Being tested
- Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation, Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation + right atrial driver ablation
- Keywords
- Atrial fibrillation, Right atrium
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablationProcedure or surgery
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and left atrial driver ablation.
Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation + right atrial driver ablationProcedure or surgery
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping , left atrial driver ablation and right atrial driver ablation.
| Study group | Role | What they receive |
|---|---|---|
| LA + RA ablation | Patients with persistent atrial fibrillation and right atrial enlargement received adjunctive right atrial ablation when left atrial ablation did not terminate atrial fibrillation. Receives: Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation + right atrial driver ablation | |
| LA ablation only | Patients with persistent atrial fibrillation and right atrial enlargement received left atrial ablation only Receives: Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial fibrillation (AF) recurrence rate
AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
Measured: at 12 months post procedure
Secondary outcomes (1)
atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
Measured: at 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Nov 2021
- Primary completion1 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Retrospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227586
- Sponsor's protocol ID
- RAAFDA
- Status last verified
- Jan 2022
- First submitted
- 26 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation With Right Atrial Enlargement
- ClinicalTrials.gov ID
- NCT05227586
- Acronym / sponsor ID
- RAAFDA
- Keywords
- Atrial fibrillation, Right atrium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 7 Feb 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 is retrospective cohort study testing whether patients with persistent atrial fibrillation and right atrial enlargement may benefit from adjunctive right atrial ablation.
Detailed description
This is retrospective cohort study testing whether patients with persistent atrial fibrillation and right atrial enlargement may benefit from adjunctive RA ablation.
We enrolled 65 patients with persistent atrial fibrillation and right atrial enlargement received adjunctive right atrial ablation. These patients were 1:2 match with 130 patients received left atrial ablation only. Atrial fibrillation recurrence rate and other paremeters were analyzed to evaluate the efficacy of adjunctive right atrial ablation in this subset of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LA + RA ablation | – | Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation + right atrial driver ablationPatients with persistent atrial fibrillation and right atrial enlargement received adjunctive right atrial ablation when left atrial ablation did not terminate atrial fibrillation. |
| LA ablation only | – | Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablationPatients with persistent atrial fibrillation and right atrial enlargement received left atrial ablation only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population enrolled were patients with persistent atrial fibrillation and right atrial enlargement received catheter ablation for the first time in our institution. Patients with a history of catheter ablation, valvular heart disease, hypertrophic or dilated cardiomyopathy and unavailable of follow-up data were excluded
Key inclusion criteria (3 listed)
- Aged 18 to 80 years old;
- Persistent AF with right atrial enlargement;
- Nonresponse or intolerance to ≥1 antiarrhythmic drug.
Key exclusion criteria (4 listed)
- History of catheter ablation;
- valvular heart disease;
- hypertrophic cardiomyopathy or dilated cardiomyopathy;
- Without follow-up data
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 |
|---|---|---|
| Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablationPatients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and left atrial driver ablation. | Procedure or surgery | LA ablation only |
| Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + left atrial driver ablation + right atrial driver ablationPatients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping , left atrial driver ablation and right atrial driver ablation. | Procedure or surgery | LA + RA ablation |
Primary outcome
atrial fibrillation (AF) recurrence rate
Time frame: at 12 months post procedure
AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
1 secondary outcome
atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
Time frame: at 12 months post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Persistent Atrial Fibrillation and Right Atrial Enlargement, run by Shanghai Chest 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 7 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atrial fibrillation (AF) recurrence rate (time frame: at 12 months post procedure). 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 7 Feb 2022.