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Clinical Study on the Efficiency of Rapid Arrhythmia Mapping Using EasyStars™ High Density Mapping Catheter Applications | Clinical Trials | Clareo Health

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Clinical Study on the Efficiency of Rapid Arrhythmia Mapping Using EasyStars™ High Density Mapping Catheter Applications

NCT07079813•Shanghai MicroPort EP MedTech Co., Ltd.

View on ClinicalTrials.gov

Summary

Detailed Description

The primary objective of this study was to evaluate the clinical feasibility, safety, and surgical characteristics of the EasyStars™ High Density Mapping Catheterin in patients with complex arrhythmias. In addition, the study assessed the catheter's usability and mapping performance through postoperative physician feedback.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Clinical diagnosis: Ventricular tachycardia (VT)
•1. Patients aged between 18 and 80 years;
•2. Confirmed diagnosis of ventricular tachycardia (VT) via electrocardiogram (ECG) or 24-hour Holter monitoring;
•3. The patient has experienced at least one episode of VT in the past 6 months and exhibits symptoms of sustained or paroxysmal ventricular tachycardia;
•4. The patient meets the criteria for ablation surgery and has clear indications for ablation;
•5. The patient is in good general health and able to tolerate surgery (no severe underlying heart disease, such as severe heart failure or severe coronary artery disease);
•6. Voluntarily participates and signs an informed consent form.
•1. Patients aged 18 to 80 years;
•2. Diagnosed with atrial tachycardia (AT) by electrocardiogram (ECG) or Holter monitoring;
•3. Patients presenting with clinical symptoms such as palpitations, chest tightness, or fatigue;
+17 more criteria

Exclusion Criteria

•1. Uncontrolled heart failure (New York Heart Association functional class III-IV);
•2. History of acute or progressive myocardial infarction;
•3. Severe pulmonary, hepatic, or renal disease;
•4. Valvular heart disease or congenital heart disease;
•5. Excessive use of medications or medication intolerance (e.g., beta-blockers, antiarrhythmic drugs);
•2. Clinical diagnosis: Atrial tachycardia (AT)
•1. Patients with severe valvular heart disease or congenital heart disease;
•2. Patients with severe left ventricular or right ventricular heart failure;
•3. Patients with severe systemic diseases, such as liver failure, kidney failure, or tumours;
•4. Patients with cardiomyopathy or aortic dissection;
+12 more criteria

Key Dates

Start Date

August 30, 2025

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2027

Last Updated

July 31, 2025

Enrollment

300

ESTIMATED participants

Conditions

Ventricular Tachycardia (VT)Atrial TachycardiaTypical Atrial FlutterParoxysmal Atrial Fibrillation (PAF)

Interventions

EasyStars™ High Density Mapping Catheter

DEVICE

Pulsed-Field Ablation for Recurrent Atypical Atrial Flutter

NCT07362134

Atypical Atrial FlutterAtrial Flutter

View study

COMPLETEDNA

A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

NCT05373862

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study on the Efficiency of Rapid Arrhythmia Mapping Using EasyStars™ High Density Mapping Catheter Applications

Inclusion Criteria

Exclusion Criteria

Pulsed-Field Ablation for Recurrent Atypical Atrial Flutter

A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

Non-Invasive Programmed Stimulation (NIPS) to Guide the Subsequent VT Therapeutic Strategies

MCG for Localization of Tachyarrhythmia's Origin

Study of Interference Between Oral Anticoagulants and Heparin During Ablation of Atrial Fibrillation (AF) or Left Atrial Tachycardia (GAD) by Catheter.

A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation