Paroxysmal Atrial FibrillationPASPANCT07191626
Pulsed Field Ablation of SVC and PV in Paroxysmal Atrial Fibrillation (PASPA Study)
A study testing PFA - PV + SVCI and PFA - PVI only in people with Paroxysmal Atrial Fibrillation and Paroxysmal Atrial Fibrillation (PAF), run by Changhai Hospital at 1 site in China.
Trial summary
The PASPA study is a multicenter, randomized trial comparing Pulmonary Vein Isolation (PVI) alone versus PVI plus Superior Vena Cava Isolation (SVCI) using Pulsed Field Ablation (PFA) in patients with paroxysmal atrial fibrillation (PAF). 650 participants will be followed for 12 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Paroxysmal Atrial Fibrillation (PAF)
- What is being tested?
- PFA - PV + SVCI and PFA - PVI only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 1 Nov 2027
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented paroxysmal AF (episodes self-terminating within 7 days), evidenced by ECG, Holter, or event monitor
- Age between 18 and 80 years
- Willing and able to provide written informed consent
Who cannot join
- Intracardiac thrombus (left atrium or left atrial appendage)
- Left atrial anterior-posterior diameter > 60 mm
- Absolute contraindication to anticoagulation therapy
- Stroke or myocardial infarction within 1 month prior to enrollment
- Uncontrolled hyperthyroidism
- Pregnancy or planning pregnancy
Show all 10Show fewer
- Life expectancy less than 1 year
- Previous atrial fibrillation ablation procedure
- Known or suspected AF triggers primarily originating from the SVC (based on pre-procedure mapping, if available)
- Inability or unwillingness to participate in the study or comply with follow-up requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
zhifu guo, MD contact
China1 site
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital). No. 168, Changhai Road, Yangpu District, Shanghai, China.
Shanghai, Shanghai Municipality, 200040
songqun huang, MD, 13585588854
About this study
Official title: Pulsed Field Ablation of Superior Vena Cava in Addition to Pulmonary Vein in Paroxysmal Atrial Fibrillation: A Multicenter Randomized Controlled Trial (PASPA Study)
The PASPA study is a multicenter, randomized trial comparing Pulmonary Vein Isolation (PVI) alone versus PVI plus Superior Vena Cava Isolation (SVCI) using Pulsed Field Ablation (PFA) in patients with paroxysmal atrial fibrillation (PAF).
650 participants will be followed for 12 months. The main goal is to see if adding SVCI reduces arrhythmia recurrence without increasing complications such as phrenic nerve injury or sinus node dysfunction.
Read the detailed description
The PASPA study addresses the limitations of traditional pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF), where recurrence rates remain significant due to non-pulmonary vein triggers such as the superior vena cava (SVC). Traditional ablation near the SVC carries risks of phrenic nerve and sinus node injury, and acute isolation success rates are only 75%-85%. Pulsed Field Ablation (PFA) selectively ablates cardiomyocytes through irreversible electroporation while sparing adjacent nerves and vessels, allowing safer SVC isolation. This prospective, multicenter, randomized controlled trial will enroll 650 patients with documented PAF, randomly assigned to PVI alone or PVI plus SVC isolation (SVCI) using PFA. Participants will be followed for 12 months with 7-day Holter monitoring at 3, 6, and 12 months. The primary endpoint is freedom from atrial fibrillation, atrial flutter, or atrial tachycardia episodes ≥30 seconds at 12 months. Secondary endpoints include atrial fibrillation burden and procedure-related complications such as phrenic nerve injury, cardiac tamponade, and sinus node dysfunction. Preliminary animal and pilot human studies indicate that PFA achieves 100% acute SVC isolation with minimal complications. The study aims to determine whether adding SVCI to PVI improves efficacy in PAF without increasing procedural risks, providing evidence to guide standardized ablation strategies.
- Being tested
- PFA - PV + SVCI, PFA - PVI only
- Keywords
- Paroxysmal, Catheter Ablation, Catheter Ablation, Pulsed Field Ablation, Pulmonary Vein Isolation, Superior Vena Cava Isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFA - PV + SVCIProcedure or surgery
Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins AND the superior vena cava.
PFA - PVI onlyProcedure or surgery
Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins only. No ablation is performed in the superior vena cava.
| Study group | Role | What they receive |
|---|---|---|
| PVI + SVCI | Experimental | Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all pulmonary veins AND the superior vena cava. Receives: Procedure: PFA - PV + SVCI |
| PVI only | Active comparator | Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins ONLY. Receives: Procedure: PFA - PVI only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial arrhythmia recurrence at 12 Months
Proportion of participants without recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds, as assessed by 7-day continuous ambulatory ECG monitoring, during the 12-month follow-up period after ablation.
Measured: 12 month
Secondary outcomes (1)
Atrial Fibrillation Burden
The percentage of time spent in atrial fibrillation during the 7-day Holter monitoring periods, calculated as (total AF duration / total recording duration) * 100%.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment design. Eligible participants are randomly assigned in a 1:1 ratio to one of two study arms: (1) pulsed field ablation guided pulmonary vein isolation (PVI alone), or (2) pulsed field ablation guided pulmonary vein isolation plus superior vena cava isolation (PVI + SVC). Each participant receives only the intervention of the assigned arm. Randomization is stratified by study center to ensure balanced allocation across all 20 participating centers.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zhifu guo, MD, Principal investigator, The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191626
- Sponsor's protocol ID
- PASPA-2025-001
- Acronym
- PASPA
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results will be shared after publication of the primary results, upon reasonable request and subject to approval by the study steering committee and applicable ethical/regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Field Ablation of Superior Vena Cava in Addition to Pulmonary Vein in Paroxysmal Atrial Fibrillation: A Multicenter Randomized Controlled Trial (PASPA Study)
- ClinicalTrials.gov ID
- NCT07191626
- Acronym / sponsor ID
- PASPA / PASPA-2025-001
- Keywords
- Paroxysmal, Catheter Ablation, Catheter Ablation, Pulsed Field Ablation, Pulmonary Vein Isolation, Superior Vena Cava Isolation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 25 Sep 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 PASPA study is a multicenter, randomized trial comparing Pulmonary Vein Isolation (PVI) alone versus PVI plus Superior Vena Cava Isolation (SVCI) using Pulsed Field Ablation (PFA) in patients with paroxysmal atrial fibrillation (PAF).
650 participants will be followed for 12 months. The main goal is to see if adding SVCI reduces arrhythmia recurrence without increasing complications such as phrenic nerve injury or sinus node dysfunction.
Detailed description
The PASPA study addresses the limitations of traditional pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF), where recurrence rates remain significant due to non-pulmonary vein triggers such as the superior vena cava (SVC). Traditional ablation near the SVC carries risks of phrenic nerve and sinus node injury, and acute isolation success rates are only 75%-85%. Pulsed Field Ablation (PFA) selectively ablates cardiomyocytes through irreversible electroporation while sparing adjacent nerves and vessels, allowing safer SVC isolation. This prospective, multicenter, randomized controlled trial will enroll 650 patients with documented PAF, randomly assigned to PVI alone or PVI plus SVC isolation (SVCI) using PFA. Participants will be followed for 12 months with 7-day Holter monitoring at 3, 6, and 12 months. The primary endpoint is freedom from atrial fibrillation, atrial flutter, or atrial tachycardia episodes ≥30 seconds at 12 months. Secondary endpoints include atrial fibrillation burden and procedure-related complications such as phrenic nerve injury, cardiac tamponade, and sinus node dysfunction. Preliminary animal and pilot human studies indicate that PFA achieves 100% acute SVC isolation with minimal complications. The study aims to determine whether adding SVCI to PVI improves efficacy in PAF without increasing procedural risks, providing evidence to guide standardized ablation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment design. Eligible participants are randomly assigned in a 1:1 ratio to one of two study arms: (1) pulsed field ablation guided pulmonary vein isolation (PVI alone), or (2) pulsed field ablation guided pulmonary vein isolation plus superior vena cava isolation (PVI + SVC). Each participant receives only the intervention of the assigned arm. Randomization is stratified by study center to ensure balanced allocation across all 20 participating centers.
| Arm | Type | Receives |
|---|---|---|
| PVI + SVCI | Experimental | Procedure: PFA - PV + SVCICatheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all pulmonary veins AND the superior vena cava. |
| PVI only | Active comparator | Procedure: PFA - PVI onlyCatheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins ONLY. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented paroxysmal AF (episodes self-terminating within 7 days), evidenced by ECG, Holter, or event monitor
- Age between 18 and 80 years
- Willing and able to provide written informed consent
Key exclusion criteria (10 listed)
- Intracardiac thrombus (left atrium or left atrial appendage)
- Left atrial anterior-posterior diameter > 60 mm
- Absolute contraindication to anticoagulation therapy
- Stroke or myocardial infarction within 1 month prior to enrollment
- Uncontrolled hyperthyroidism
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 |
|---|---|---|
| PFA - PV + SVCICatheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins AND the superior vena cava. | Procedure or surgery | PVI + SVCI |
| PFA - PVI onlyCatheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins only. No ablation is performed in the superior vena cava. | Procedure or surgery | PVI only |
Primary outcome
Freedom from atrial arrhythmia recurrence at 12 Months
Time frame: 12 month
Proportion of participants without recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds, as assessed by 7-day continuous ambulatory ECG monitoring, during the 12-month follow-up period after ablation.
1 secondary outcome
Atrial Fibrillation Burden
Time frame: 12 month
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 25 Sep 2025.
- Individual participant dataSharing planned: Yes. Individual participant data underlying the results will be shared after publication of the primary results, upon reasonable request and subject to approval by the study steering committee and applicable ethical/regulatory requirements.
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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.
zhifu guo, MD contact
zhifu guo, MD principal investigator
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFA - PV + SVCI and PFA - PVI only in people with Paroxysmal Atrial Fibrillation and Paroxysmal Atrial Fibrillation (PAF), run by Changhai 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 10 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 25 Sep 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 songqun huang, MD (+86-13585588854, hsq8593@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial arrhythmia recurrence at 12 Months (time frame: 12 month). 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 25 Sep 2025.