Persistent Atrial FibrillationPROMPT-AFNCT04497376
Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
A study testing upgraded '2C3L' and pulmonary vein antral isolation in people with Persistent Atrial Fibrillation and Catheter Ablation, run by Beijing Anzhen Hospital at 12 sites in China.
Trial summary
Catheter ablation has emerged as an important treatment option for patients with symptomatic atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered the cornerstone technique of AF ablation and has shown promise in treating paroxysmal atrial fibrillation (PAF). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Catheter Ablation
- What is being tested?
- upgraded '2C3L' and pulmonary vein antral isolation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 12 sitesChina
- Study dates
- 27 Aug 2021to 18 Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all the following criteria to be included in the study:
- age between 18 and 80,
- patients undergoing a first-time ablation procedure for non-valvular AF,
- patients with defined as a sustained episode more than 3 months
- PeAF documented by ECG, Holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within 90 days6 months of the ablation procedure,
- patients experienced symptoms caused by AF and these symptoms include but are not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath,
Show all 19Show fewer
- AF refractory to at least one AAD,
- willingness, ability and commitment to provide informed consent and participate in follow-up evaluations.
- Exclusion criteria Patients are to be excluded if any of the following criteria is met：
- patients with paroxysmal AF,
- patients with AF secondary to an obvious reversible cause,
- patients with left atrial diameter ≥ 60 mm in the parasternal long axis view,
- left ventricular ejection fraction (LVEF) < 30%,
- patients with triple (aspirin, clopidogrel and OAC) or dual (clopidogrel and OAC) antithrombotic therapy which predispose patients to higher risk of periprocedural bleeding. (e.g., Coronary percutaneous transluminal coronary angioplasty (PTCA)/stenting within the previous 90 days),
- patients with contraindication to anticoagulation,
- patients with contraindication to right or left sided heart catheterization,
- pregnancy,
- life expectancy less than 1 year (advanced malignant tumor, end stage renal disease, etc.),
- patients cannot be removed from antiarrhythmic drugs for reasons other than AF.
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Shengli Oilfield Central Hospital
Dongying, Shandong, 257034
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510235
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250013
Shandong Provincial Hospital
Jinan, Shandong, 250021
Jiangsu Provincial Hospital
Nanjing, Jiangsu
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, 200127
Taizhou Hospital of Zhejiang Province
Taizhou, Hangzhou, 318050
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 451464
About this study
Official title: Prospective Randomized Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
Catheter ablation has emerged as an important treatment option for patients with symptomatic atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered the cornerstone technique of AF ablation and has shown promise in treating paroxysmal atrial fibrillation (PAF). However, there is no unique strategy for ablation of persistent AF (PeAF), whether PVI alone is sufficient to prevent patients from recurrence remains controversial. The PROMPT-AF study is a prospective, multicenter, randomized trial involving a blinded assessment of outcomes, which is designed to compare arrhythmia-free survival between PVI and an ablation strategy termed upgraded '2C3L' for ablation of PeAF.
Read the detailed description
The PROMPT-AF study will include 498 patients undergoing their first catheter ablation of PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1 fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM, bilateral circumferential PVI, and three linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavotricuspid isthmus. The follow-up duration is 12 months. The primary endpoint is the rate of documented atrial tachycardia arrhythmias of >30 seconds, without any antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding a blanking period of 3 months).
- Conditions
- Persistent Atrial Fibrillation, Catheter Ablation
- Being tested
- upgraded '2C3L', pulmonary vein antral isolation
- Keywords
- Pulmonary vein antral isolation, Upgraded '2C3L', Arrhythmia-free survival
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upgraded '2C3L'Procedure or surgery
Also called EI-VOM+2C3L
Patients randomized to the upgraded '2C3L' arm will first undergo EI-VOM, followed by the '2C3L' ablation step. The details include: (1). EI-VOM procedure: An 8.5-French-long sheath or a steerable long sheath is sent to the coronary sinus (CS) via the femoral vein. A JR4.0 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a BMW wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated with 6 to 8 atm in the VOM. A selective venogram of the VOM is obtained by slowly injecting 1 mL of contrast medium. Then, ethanol is slowly injected into the VOM and selective venography of the VOM is repeated. (2) . After EI-VOM, radiofrequency ablation was performed to achieve bilateral pulmonary vein isolation and bidirectional block of mitral isthmus line, roof line, and cavotricuspid isthmus line. (3). Any organized AT observed during the procedure will be targeted as well.
pulmonary vein antral isolationProcedure or surgery
Also called PVI
After reconstructing the left atrial geometry, PVI will be performed (the right PV antrum (PVA) will be ablated first, followed by the left PVA. ) in a wide area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. The endpoint of the circumferential PVA ablation procedure is to achieve electrical bilateral PV isolation, that is, the PV potentials associated with atrial electrical activity cannot be recorded during sinus rhythm or CS pacing (entrance block). A waiting period of at least 20 min (after the last PV is isolated) will be used during which spontaneous PV reconnection will be related. , and tDemonstration of exit block (he by pacing in the PV cannot be and proving the absence of transmitted conduction to capture the atrium) may be performed but is not mandatory. Any organized AT observed during the procedure will be targeted as well.
| Study group | Role | What they receive |
|---|---|---|
| Upgraded '2C3L' | Experimental | Patients randomized to the upgraded '2C3L' arm will first undergo ethanol infusion in the vein of Marshall (EI-VOM) followed by the '2C3L' ablation step which includes bilateral circumferential PV antral ablation and linear ablations across the left atrial roof, mitral isthmus (MI), and cavotricuspid isthmus (CTI). Receives: Procedure: upgraded '2C3L' |
| Pulmonary vein antral isolation (PVI) | Active comparator | Patients randomized to the PVI arm will undergo right PV antrum ablation, followed by the left PVA ablation. Radiofrequency should be applied 1 cm proximal to the PV ostia in a wide-area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. Receives: Procedure: pulmonary vein antral isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate of atrial tachycardia arrhythmias
freedom from any documented atrial arrhythmia after a 3-months post-ablation blanking period, including AF, AT, and AFL, for more than 30 seconds in the absence of antiarrhythmic drug (AAD) therapy.
Measured: 1 year
Secondary outcomes (8)
Freedom from AF/AT with or without AADs
Time to the first occurrence of AF, AT in the presence of AAD therapy after one ablation procedure.
Measured: 1 year
Freedom from AF/AT off AADs
Recurrent AT/AFL over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD
Measured: 1 year
Freedom from AF off AADs
Recurrent AF over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD
Measured: 1 year
AF burden
AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period,
Measured: 1 year
Freedom from AF/AT after multiple procedures
freedom from any documented atrial arrhythmia (AF, AT, and AFL) of more than 30 seconds, after repeated ablation1 or 2 ablation procedures, including AF, AT, and AFL, for more than 30 seconds on/off AADs.
Measured: 1 year
Incidence of procedural complications
cardiac tamponade or perforation, phrenic nerve injury, acute coronary occlusion, leading to death, intervention required, or prolonged hospitalization, strokes /thromboembolism related to AF ablation, pulmonary vein stenosis, left atrial oesophageal fistula, and vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula).
Measured: Within 1 month after the procedure
AFEQT score change between baseline and 12 month
Quality of life assessed by AF effect on quality-of-life (AFEQT) questionaire
Measured: 1 year
EQ5D score change between baseline and 12 month
Quality of life assessed by EuroQol 5-dimension (EQ5D) scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start27 Aug 2021
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Outcomes assessor
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Health Research Centre, The George Institute for Global Health, China, The George Institute for Global Health, Australia, Fukuoka University
- Responsible party
- Principal investigator, Chang sheng Ma, Beijing Anzhen Hospital
- Investigators
- Caihua Sang, MD, Principal investigator, Beijing Anzhen HospitalChangsheng Ma, MD, Principal investigator, Beijing Anzhen HospitalJianzeng Dong, MD, Principal investigator, Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou UniversityChenyang Jiang, MD, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497376
- Sponsor's protocol ID
- 2017YFC0908803
- Acronym
- PROMPT-AF
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2020
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sang C, Liu Q, Lai Y, Xia S, Jiang R, Li S, Guo Q, Li Q, Gao M, Guo X, Huang L, Liu N, Jiang C, Zuo S, Liu X, Li M, Ge W, Song S, Chen L, Xie S, Zou J, Chen K, Liu X, Hu H, Wang X, Zhang J, Wang Z, Wang C, He L, Jiang C, Tang R, Zhou N, Wang Y, Long D, Du X, Jiang C, Macle L, Dong J, Ma C; PROMPT-AF investigators. Pulmonary Vein Isolation With Optimized Linear Ablation vs Pulmonary Vein Isolation Alone for Persistent AF: The PROMPT-AF Randomized Clinical Trial. JAMA. 2025 Feb 4;333(5):381-389. doi: 10.1001/jama.2024.24438.
PubMed 39556379
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04497376
- Acronym / sponsor ID
- PROMPT-AF / 2017YFC0908803
- Conditions
- Persistent Atrial Fibrillation, Catheter Ablation
- Keywords
- Pulmonary vein antral isolation, Upgraded '2C3L', Arrhythmia-free survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Heart Health Research Centre, The George Institute for Global Health, China, The George Institute for Global Health, Australia, Fukuoka University
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 4 Aug 2020 (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.
Catheter ablation has emerged as an important treatment option for patients with symptomatic atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered the cornerstone technique of AF ablation and has shown promise in treating paroxysmal atrial fibrillation (PAF). However, there is no unique strategy for ablation of persistent AF (PeAF), whether PVI alone is sufficient to prevent patients from recurrence remains controversial. The PROMPT-AF study is a prospective, multicenter, randomized trial involving a blinded assessment of outcomes, which is designed to compare arrhythmia-free survival between PVI and an ablation strategy termed upgraded '2C3L' for ablation of PeAF.
Detailed description
The PROMPT-AF study will include 498 patients undergoing their first catheter ablation of PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1 fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM, bilateral circumferential PVI, and three linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavotricuspid isthmus. The follow-up duration is 12 months. The primary endpoint is the rate of documented atrial tachycardia arrhythmias of >30 seconds, without any antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding a blanking period of 3 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upgraded '2C3L' | Experimental | Procedure: upgraded '2C3L'Patients randomized to the upgraded '2C3L' arm will first undergo ethanol infusion in the vein of Marshall (EI-VOM) followed by the '2C3L' ablation step which includes bilateral circumferential PV antral ablation and linear ablations across the left atrial roof, mitral isthmus (MI), and cavotricuspid isthmus (CTI). |
| Pulmonary vein antral isolation (PVI) | Active comparator | Procedure: pulmonary vein antral isolationPatients randomized to the PVI arm will undergo right PV antrum ablation, followed by the left PVA ablation. Radiofrequency should be applied 1 cm proximal to the PV ostia in a wide-area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- age between 18 and 80,
- patients undergoing a first-time ablation procedure for non-valvular AF,
- patients with defined as a sustained episode more than 3 months
- PeAF documented by ECG, Holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within 90 days6 months of the ablation procedure,
- patients experienced symptoms caused by AF and these symptoms include but are not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath,
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upgraded '2C3L'Also: EI-VOM+2C3LPatients randomized to the upgraded '2C3L' arm will first undergo EI-VOM, followed by the '2C3L' ablation step. The details include: (1). EI-VOM procedure: An 8.5-French-long sheath or a steerable long sheath is sent to the coronary sinus (CS) via the femoral vein. A JR4.0 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a BMW wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated with 6 to 8 atm in the VOM. A selective venogram of the VOM is obtained by slowly injecting 1 mL of contrast medium. Then, ethanol is slowly injected into the VOM and selective venography of the VOM is repeated. (2) . After EI-VOM, radiofrequency ablation was performed to achieve bilateral pulmonary vein isolation and bidirectional block of mitral isthmus line, roof line, and cavotricuspid isthmus line. (3). Any organized AT observed during the procedure will be targeted as well. | Procedure or surgery | Upgraded '2C3L' |
| pulmonary vein antral isolationAlso: PVIAfter reconstructing the left atrial geometry, PVI will be performed (the right PV antrum (PVA) will be ablated first, followed by the left PVA. ) in a wide area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. The endpoint of the circumferential PVA ablation procedure is to achieve electrical bilateral PV isolation, that is, the PV potentials associated with atrial electrical activity cannot be recorded during sinus rhythm or CS pacing (entrance block). A waiting period of at least 20 min (after the last PV is isolated) will be used during which spontaneous PV reconnection will be related. , and tDemonstration of exit block (he by pacing in the PV cannot be and proving the absence of transmitted conduction to capture the atrium) may be performed but is not mandatory. Any organized AT observed during the procedure will be targeted as well. | Procedure or surgery | Pulmonary vein antral isolation (PVI) |
Primary outcome
The recurrence rate of atrial tachycardia arrhythmias
Time frame: 1 year
freedom from any documented atrial arrhythmia after a 3-months post-ablation blanking period, including AF, AT, and AFL, for more than 30 seconds in the absence of antiarrhythmic drug (AAD) therapy.
8 secondary outcomes
Freedom from AF/AT with or without AADs
Time frame: 1 year
Freedom from AF/AT off AADs
Time frame: 1 year
Freedom from AF off AADs
Time frame: 1 year
AF burden
Time frame: 1 year
Freedom from AF/AT after multiple procedures
Time frame: 1 year
Incidence of procedural complications
Time frame: Within 1 month after the procedure
AFEQT score change between baseline and 12 month
Time frame: 1 year
EQ5D score change between baseline and 12 month
Time frame: 1 year
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 19 Jul 2024.
- Derived from this study: PubMed 39556379Sang C, Liu Q, Lai Y, Xia S, Jiang R, Li S, Guo Q, Li Q, Gao M, Guo X, Huang L, Liu N, Jiang C, Zuo S, Liu X, Li M, Ge W, Song S, Chen L, Xie S, Zou J, Chen K, Liu X, Hu H, Wang X, Zhang J, Wang Z, Wang C, He L, Jiang C, Tang R, Zhou N, Wang Y, Long D, Du X, Jiang C, Macle L, Dong J, Ma C; PROMPT-AF investigators. Pulmonary Vein Isolation With Optimized Linear Ablation vs Pulmonary Vein Isolation Alone for Persistent AF: The PROMPT-AF Randomized Clinical Trial. JAMA. 2025 Feb 4;333(5):381-389. doi: 10.1001/jama.2024.24438.
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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.
Caihua Sang, MD principal investigator
Beijing Anzhen Hospital
Changsheng Ma, MD principal investigator
Beijing Anzhen Hospital
Jianzeng Dong, MD principal investigator
Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upgraded '2C3L' and pulmonary vein antral isolation in people with Persistent Atrial Fibrillation and Catheter Ablation, run by Beijing Anzhen Hospital at 12 sites 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 19 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: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
The recurrence rate of atrial tachycardia arrhythmias (time frame: 1 year). 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 NCT04497376, which also lists 1 linked publication.
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 19 Jul 2024; AzTrials last refreshed its copy on 31 Oct 2026.