Paroxysmal Atrial Fibrillation (PAF)NCT07789925
Sphere-9 PAF China Study
A study testing Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System in people with Paroxysmal Atrial Fibrillation (PAF), run by Medtronic Cardiac Ablation Solutions at 10 sites in China.
Trial summary
The goal of this clinical trial is to find out if the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System is safe and works to treat recurrent symptomatic paroxysmal atrial fibrillation (PAF) in adults who have not been helped by, cannot tolerate, or cannot take certain medicines for PAF. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation (PAF)
- What is being tested?
- Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 10 sitesChina
- Study dates
- 2 Sep 2026to Apr 2028
- 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
- Failure of, intolerance to, or contraindication to at least one Class I-IV AAD for the treatment of PAF, as evidenced by recurrent symptomatic AF. A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following:
- a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and
- at least 1 electrocardiographically documented episode within 12 months prior to enrollment
- Adults who are ≥18 and ≤80 years of age on the day of enrollment.
- Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Who cannot join
- Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration > 7 days
- AF that required three (3) or more distinct cardioversions in the preceding 12 months.
- LA anteroposterior > 5.0 cm (by MRI, CT, or TTE)
- Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
- Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
- Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
Show all 41Show fewer
- Presence of a permanent pacemaker, biventricular pacemaker, , or any type of implantable cardiac defibrillator (with or without biventricular pacing function), , or presence of a loop recorder or insertable cardiac monitor (ICM) that has not reached manufacturer-defined end of service (or equivalent end-of-life state)
- Presence of any pulmonary vein stents
- Known pre-existing pulmonary vein stenosis
- Pre-existing hemidiaphragmatic paralysis
- Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy
- Moderate to severe aortic or mitral valve stenosis
- Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR)
- Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
- Unstable angina
- NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD)
- Severe lung disease, primary pulmonary hypertension, or any lung disease with abnormal blood gases or requiring supplemental oxygen
- Rheumatic heart disease
- Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
- Contraindication to or unwillingness to use systemic anticoagulation
- Documented left atrial thrombus on imaging
- Active systemic infection or sepsis
- Hypertrophic cardiomyopathy
- Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
- Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
- Carotid stenting or endarterectomy
- History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
- Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
- Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
- Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
- Known allergies or hypersensitivities to adhesives
- Body mass index > 40 kg/m2
- Atrial myxoma
- Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
- Renal insufficiency with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, or any history of renal failure requiring dialysis or renal transplant
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
- Known drug or alcohol dependency
- Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results.
- Treatment with Amiodarone within the 3 months prior to enrollment
- Amyloid heart disease (cardiac amyloidosis)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Xin Wang, MD, PHD contact
10 sites in 1 country
China10 sites
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Kuo Zhang, +86 10-68314466, kzhang23@126.com
West China Hospital Sichuan University
Chengdu
Xianjin Hu, +86 28-85422114, huaxijin_zj@163.com
Guangdong Province People's Hospital
Guangzhou
Sijin Zhang, +86 20-83827812, sijinzhang0@163.com
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Jian Ye, +86 571-87783777, ye_jian@zju.edu.cn
Jiangsu Province Hospital
Nanjing
Youmei Shen, +86 25-83714511, symnjmu@163.com
Nanjing Drum Tower Hospital
Nanjing
Fu Chen, +86 25-83106666, chenfukai.xin@163.com
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Shanghai
Yu Yu, +86 21-64370045, yy13125@rjh.com.cn
Chinese People's Liberation Army Northern Theater Command General Hospital
Shenyang
Ping Zhang, +86 24-28856114, haoran20151020@163.com
Tianjin Chest Hospital
Tianjin
Henan Zhang, +86 22-88182099, comic1988@126.com
The Fisrt Affliated Hopital of Xinjiang Medical Universtiy
Ürümqi
Jiasuoer Xiaokereti, +86 991-4362930, shuk111@163.com
About this study
Official title: Treatment of Paroxysmal Atrial Fibrillation With the Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System in China
The goal of this clinical trial is to find out if the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System is safe and works to treat recurrent symptomatic paroxysmal atrial fibrillation (PAF) in adults who have not been helped by, cannot tolerate, or cannot take certain medicines for PAF.
The main questions it aims to answer are:
Read more
Is the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System safe for treating PAF? Does the treatment help keep patients free from atrial fibrillation and other abnormal heart rhythms during the 12 months after the procedure?
Participants will:
Have their heart rhythm assessed before and after the ablation procedure. Have PAF treated using the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System.
Have follow-up visits at 3, 6, and 12 months after the procedure.
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Being tested
- Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation SystemDevice
Pulsed field catheter ablation for pulmonary vain isolation.
| Study group | Role | What they receive |
|---|---|---|
| Participants receive treatment with the investigational devices | Experimental | Participants with recurrent symptomatic PAF who are refractory, intolerant or contraindicated to drugs and planned for catheter ablation will be treated with Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System. Receives: Device: Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety endpoint: Freedom from Device- and/or Procedure-Related Serious Adverse Events Through 6 Months Post-Ablation
The proportion of participants who are free from device- and/or procedure-related serious adverse events through 6 months after the ablation procedure.
Measured: Through 6 months post-ablation
Primary effectiveness endpoint: Treatment Success at 12 Months Post-Ablation
The proportion of participants achieving treatment success (freedom from documented recurrence of AF, AT, or AFL based on electrocardiographic data) at 12 months after the ablation procedure and excluding a 90-day blanking period.
Measured: 12 months post-ablation
Secondary outcomes (2)
Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaires score from baseline through 12 months after the index ablation procedure
Change in AFEQT score from baseline to 12 months after the index ablation procedure. The AFEQT questionnaire assesses the impact of atrial fibrillation on a participant's quality of life. The overall score ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline through 12 months after the index ablation
Change in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) composite score from baseline through 12 months after the index ablation procedure
Change in EQ-5D-5L composite score from baseline to 12 months after the index ablation procedure. The EQ-5D-5L Questionnaire is a standardized instrument for measuring health status. The Chinese EQ-5D-5L value set will be used to calculate the composite score. The composite score ranges from -0.391 to 1, with higher scores indicating better health status.
Measured: Baseline through 12 months after the index ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start2 Sep 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial Fibrillation (PAF)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liqun Wu, PHD, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789925
- Sponsor's protocol ID
- MDT25046
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Paroxysmal Atrial Fibrillation With the Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System in China
- ClinicalTrials.gov ID
- NCT07789925
- Acronym / sponsor ID
- MDT25046
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 27 Aug 2026 (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 goal of this clinical trial is to find out if the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System is safe and works to treat recurrent symptomatic paroxysmal atrial fibrillation (PAF) in adults who have not been helped by, cannot tolerate, or cannot take certain medicines for PAF.
The main questions it aims to answer are:
Is the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System safe for treating PAF? Does the treatment help keep patients free from atrial fibrillation and other abnormal heart rhythms during the 12 months after the procedure?
Participants will:
Have their heart rhythm assessed before and after the ablation procedure. Have PAF treated using the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System.
Have follow-up visits at 3, 6, and 12 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receive treatment with the investigational devices | Experimental | Device: Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation SystemParticipants with recurrent symptomatic PAF who are refractory, intolerant or contraindicated to drugs and planned for catheter ablation will be treated with Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Failure of, intolerance to, or contraindication to at least one Class I-IV AAD for the treatment of PAF, as evidenced by recurrent symptomatic AF. A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following:
- Adults who are ≥18 and ≤80 years of age on the day of enrollment.
- Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Key exclusion criteria (41 listed)
- Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration > 7 days
- AF that required three (3) or more distinct cardioversions in the preceding 12 months.
- LA anteroposterior > 5.0 cm (by MRI, CT, or TTE)
- Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
- Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
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 |
|---|---|---|
| Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation SystemPulsed field catheter ablation for pulmonary vain isolation. | Device | Participants receive treatment with the investigational devices |
Primary outcome
Primary safety endpoint: Freedom from Device- and/or Procedure-Related Serious Adverse Events Through 6 Months Post-Ablation
Time frame: Through 6 months post-ablation
The proportion of participants who are free from device- and/or procedure-related serious adverse events through 6 months after the ablation procedure.
Primary effectiveness endpoint: Treatment Success at 12 Months Post-Ablation
Time frame: 12 months post-ablation
The proportion of participants achieving treatment success (freedom from documented recurrence of AF, AT, or AFL based on electrocardiographic data) at 12 months after the ablation procedure and excluding a 90-day blanking period.
2 secondary outcomes
Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaires score from baseline through 12 months after the index ablation procedure
Time frame: Baseline through 12 months after the index ablation
Change in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) composite score from baseline through 12 months after the index ablation procedure
Time frame: Baseline through 12 months after the index ablation procedure
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 27 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Paroxysmal Atrial Fibrillation (PAF)
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Paroxysmal 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)
Recruiting
Feasibility Study of the FARAFLEX Mapping and PFA System
Atrial Fibrillation, Persistent Atrial Fibrillation
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.
Xin Wang, MD, PHD contact
Liqun Wu, PHD, MD principal investigator
Ruijin Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System in people with Paroxysmal Atrial Fibrillation (PAF), run by Medtronic Cardiac Ablation Solutions at 10 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 5 inclusion and 41 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
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 Rachel Zhang (+86 21 38986062, rachel.zhang2@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint: Freedom from Device- and/or Procedure-Related Serious Adverse Events Through 6 Months Post-Ablation (time frame: Through 6 months post-ablation). The study lists 2 primary outcomes in all. 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 27 Aug 2026.