Atrial Fibrillation Clinical Trials

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Grid eXplore Mapping Study

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of the trial is to find out if the Grid X Mapping Catheter and EnSite X EP System with EnSite X Software v3.1.1, the devices that are being studied, are safe and effective in treating Chinese patients who have atrial fibrillation. Participants will receive a procedure called catheter mapping and ablation to treat their abnormal heart rhythms and are required to complete 4 follow-up visits at 7 days, 3 months, 6 months and 12 months after the procedure for checkups and tests.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subject must provide written informed consent prior to any clinical investigation-related procedure.

• Subject is at least 18 years of age.

• Documented symptomatic paroxysmal AF, defined as:

‣ Physician's note indicating self-terminating AF AND

⁃ Electrocardiographically documented AF NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.

• Subject plans to undergo a cardiac electroanatomic mapping and ablation procedure to treat their paroxysmal AF.

• Able and willing to comply with all trial requirements including pre-procedure, post-procedure, and follow-up testing and requirements

Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Ningbo University
NOT_YET_RECRUITING
Ningbo
Contact Information
Primary
Rio Zhan
wanlei.zhan@abbott.com
+86-21-2320 4181
Time Frame
Start Date: 2026-04-02
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 200
Treatments
Experimental: Grid X and EnSite X v3.1.1 Software
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov