Persistent Atrial FibrillationNCT06837441
PerAF: AF Termination vs Prespecified Ablation
A study testing Atrial Fibrillation Termination and Prespecified Ablation in people with Persistent Atrial Fibrillation, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The design of this study is an intervention, randomized, controlled study and contains two randomized groups：（1）AF-termination group；（2）Prespecified-ablation group. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Atrial Fibrillation Termination and Prespecified Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Jun 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 18 and 80 years old;
- Patients undergoing a first-time ablation procedure for PersAF, and in spontaneous AF at the beginning of the procedure;
- Diagnosed as persistent AF according to the latest clinical guidelines，with atrial fibrillation lasting for at least one month;
- Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment;
- Patients must be able and willing to provide written informed consent to participate in this study;
- Patients must be willing and able to comply with all study follow- up requirements.
Who cannot join
- .Uncontrolled congestive heart failure, EF <35%;
- . History of severe valve disease and/or prosthetic valve replacement;
- . Myocardial infarction or stroke within 6 months;
- . Severe congenital heart disease;
- . Left atrial diameter ≥60mm;
- . Contrast agent allergy;
Show all 14Show fewer
- . The use of anticoagulant drugs is contraindicated;
- . Severe lung disease;
- . Left atrial thrombus confirmed by preoperative esophageal ultrasound;
- .Contraindications for cardiac catheterization;
- .Prior left atrial ablation (surgical or catheter);
- .Have performed any cardiac surgery within 2 months;
- .Poor general health;
- .Life expectancy < 12 months, including factors such as physical inability to tolerate ablation or unstable disease conditions.-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atrial Fibrillation Termination Versus Prespecified Ablation for Persistent Atrial Fibrillation:A Pilot Study
The design of this study is an intervention, randomized, controlled study and contains two randomized groups：（1）AF-termination group；（2）Prespecified-ablation group.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Atrial Fibrillation Termination, Prespecified Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial Fibrillation TerminationProcedure or surgery
Pursuing Atrial Fibrillation Termination as a Procedural Endpoint
Prespecified AblationProcedure or surgery
Prespecified Ablation Strategy Followed by Cardioversion
| Study group | Role | What they receive |
|---|---|---|
| AF-termination group | Experimental | Not described Receives: Procedure: Atrial Fibrillation Termination |
| Prespecified-ablation group | Sham comparator | Not described Receives: Procedure: Prespecified Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months follow up after a single ablat
Measured: 12 months
Secondary outcomes (5)
Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months；
Measured: 12 months
Freedom from AF/AT/AFL after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months
Measured: 12 months
Freedom from AF after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months
Measured: 12 months
Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure
Measured: 12 months
Incidence of periprocedural adverse events.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2024
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Shanghai Yangpu Central Hospital, Jinshan Hospital Affiliated to Fudan University
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837441
- Sponsor's protocol ID
- TPAF
- Status last verified
- Jan 2023
- First submitted
- 16 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Termination Versus Prespecified Ablation for Persistent Atrial Fibrillation:A Pilot Study
- ClinicalTrials.gov ID
- NCT06837441
- Acronym / sponsor ID
- TPAF
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- The Shanghai Yangpu Central Hospital, Jinshan Hospital Affiliated to Fudan University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 20 Feb 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.
The design of this study is an intervention, randomized, controlled study and contains two randomized groups：（1）AF-termination group；（2）Prespecified-ablation group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF-termination group | Experimental | Procedure: Atrial Fibrillation Termination |
| Prespecified-ablation group | Sham comparator | Procedure: Prespecified Ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged between 18 and 80 years old;
- Patients undergoing a first-time ablation procedure for PersAF, and in spontaneous AF at the beginning of the procedure;
- Diagnosed as persistent AF according to the latest clinical guidelines，with atrial fibrillation lasting for at least one month;
- Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment;
- Patients must be able and willing to provide written informed consent to participate in this study;
Key exclusion criteria (14 listed)
- .Uncontrolled congestive heart failure, EF <35%;
- . History of severe valve disease and/or prosthetic valve replacement;
- . Myocardial infarction or stroke within 6 months;
- . Severe congenital heart disease;
- . Left atrial diameter ≥60mm;
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 |
|---|---|---|
| Atrial Fibrillation TerminationPursuing Atrial Fibrillation Termination as a Procedural Endpoint | Procedure or surgery | AF-termination group |
| Prespecified AblationPrespecified Ablation Strategy Followed by Cardioversion | Procedure or surgery | Prespecified-ablation group |
Primary outcome
Freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months follow up after a single ablat
Time frame: 12 months
5 secondary outcomes
Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months；
Time frame: 12 months
Freedom from AF/AT/AFL after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months
Time frame: 12 months
Freedom from AF after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months
Time frame: 12 months
Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure
Time frame: 12 months
Incidence of periprocedural adverse events.
Time frame: 12 months
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 20 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Persistent Atrial Fibrillation
Recruiting
Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
RecruitingObservational study
Association Between Circulating BDNF Levels and Atrial Cardiomyopathy in Patients Undergoing Ablation for Persistent Atrial Fibrillation
Atrial Fibrillation (AF), Cardiac Arrhythmia
Recruiting
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
Persistent Atrial Fibrillation
Recruiting
Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Not yet recruiting
A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation
Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF)
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?
A study testing Atrial Fibrillation Termination and Prespecified Ablation in people with Persistent Atrial Fibrillation, 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 6 inclusion and 14 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 20 Feb 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. Some participants in this study may receive a placebo. 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?
Freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months follow up after a single ablat (time frame: 12 months). 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 20 Feb 2025.