Sphere-9 PAF China Study

NCT07789925 | Not Yet Recruiting FDA Device

• 1 other identifier: MDT25046
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 10

Brief 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. 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.

Conditions

Paroxysmal Atrial Fibrillation (PAF)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  Baseline through 12 months after the index ablation procedure

Study Arms (1)

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.

Device: Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System

Interventions

Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System DEVICE

Pulsed field catheter ablation for pulmonary vain isolation.

Participants receive treatment with the investigational devices

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (10)

Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Location

West China Hospital Sichuan University

Chengdu, China

Location

Guangdong Province People's Hospital

Guangzhou, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Location

Jiangsu Province Hospital

Nanjing, China

Location

Nanjing Drum Tower Hospital

Nanjing, China

Location

Shanghai Jiao Tong University School of Medicine Ruijin Hospital

Shanghai, China

Location

Chinese People's Liberation Army Northern Theater Command General Hospital

Shenyang, China

Location

Tianjin Chest Hospital

Tianjin, China

Location

The Fisrt Affliated Hopital of Xinjiang Medical Universtiy

Ürümqi, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liqun Wu, PHD, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Zhang

CONTACT

+86 21 38986062; rachel.zhang2@medtronic.com

Xin Wang, MD, PHD

CONTACT

xin.wangmd@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 2, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

CN (10)