Ventricular Tachycardia (VT)Rapid ArrhythmNCT07079813
Clinical Study on the Efficiency of Rapid Arrhythmia Mapping Using EasyStars™ High Density Mapping Catheter Applications
A study testing EasyStars™ High Density Mapping Catheter in people with Ventricular Tachycardia (VT) and Atrial Tachycardia, run by Shanghai MicroPort EP MedTech Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia (VT), Atrial Tachycardia, Typical Atrial Flutter
- What is being tested?
- EasyStars™ High Density Mapping Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2025to 31 Dec 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
- Patients aged between 18 and 80 years;
- Confirmed diagnosis of ventricular tachycardia (VT) via electrocardiogram (ECG) or 24-hour Holter monitoring;
- The patient has experienced at least one episode of VT in the past 6 months and exhibits symptoms of sustained or paroxysmal ventricular tachycardia;
- The patient meets the criteria for ablation surgery and has clear indications for ablation;
- 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);
- Voluntarily participates and signs an informed consent form.
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- Patients aged 18 to 80 years;
- Diagnosed with atrial tachycardia (AT) by electrocardiogram (ECG) or Holter monitoring;
- Patients presenting with clinical symptoms such as palpitations, chest tightness, or fatigue;
- Patients diagnosed with persistent or paroxysmal atrial tachycardia and meeting the criteria for ablation therapy;
- Patients who voluntarily participate and sign an informed consent form.
- Patients aged 18 to 80 years;
- Patients diagnosed with atypical atrial flutter (AFL) via electrocardiogram (ECG) or Holter monitoring;
- Patients with clinical symptoms (e.g., palpitations, chest tightness, fatigue, etc.) that significantly impair their quality of life;
- Patients who meet the criteria for atrial tachycardia ablation and have no other severe comorbidities;
- Voluntarily participate and sign an informed consent form.
- Patients aged 18 to 80 years;
- Diagnosed with paroxysmal atrial fibrillation (PAF) via electrocardiogram (ECG) or Holter monitoring;
- Frequent episodes of paroxysmal atrial fibrillation with symptoms such as palpitations, fatigue, and dyspnoea, and meeting the criteria for ablation;
- No other severe cardiac or systemic diseases, and meeting the criteria for ablation;
- Voluntarily participating and signing the informed consent form.
- Patients aged 18 to 80 years;
- Diagnosed with persistent atrial fibrillation (PsAF) via electrocardiogram (ECG) or Holter monitoring;
- Atrial fibrillation persisting for more than 7 days and symptoms affecting the patient's quality of life;
- Clear indications for ablation and no other severe comorbidities;
- Voluntarily participating and signing an informed consent form.
Who cannot join
- Uncontrolled heart failure (New York Heart Association functional class III-IV);
- History of acute or progressive myocardial infarction;
- Severe pulmonary, hepatic, or renal disease;
- Valvular heart disease or congenital heart disease;
- Excessive use of medications or medication intolerance (e.g., beta-blockers, antiarrhythmic drugs);
- Clinical diagnosis: Atrial tachycardia (AT)
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- Patients with severe valvular heart disease or congenital heart disease;
- Patients with severe left ventricular or right ventricular heart failure;
- Patients with severe systemic diseases, such as liver failure, kidney failure, or tumours;
- Patients with cardiomyopathy or aortic dissection;
- Clinical diagnosis: atypical atrial flutter (AFL)
- Patients with severe heart disease, such as cardiomyopathy or severe valvular disease;
- Patients with severe pulmonary disease, such as pulmonary arterial hypertension;
- Patients with a history of major cardiac surgery (e.g., heart transplantation);
- Clinically diagnosed with paroxysmal atrial fibrillation (PAF)
- Patients with severe valvular heart disease, aortic dissection, or cardiomyopathy;
- High-risk patients with a history of anticoagulant therapy or currently receiving anticoagulant therapy (e.g., history of thrombosis or stroke);
- Patients with severe underlying conditions such as cancer or severe diabetes;
- Clinical diagnosis: Persistent atrial fibrillation (PsAF)
- Presence of severe valvular heart disease or cardiomyopathy;
- History of stroke or clinical evidence of thrombus formation;
- Severe heart failure (NYHA III-IV class);
- High-risk cardiac conditions (e.g., acute myocardial infarction, coronary artery disease); In the above different types of rapid arrhythmias, the inclusion criteria primarily focus on the diagnosis and control of clinical symptoms for different types of arrhythmias, while the exclusion criteria focus on avoiding patients with severe comorbidities or those unable to tolerate surgery. Through this patient screening method, the safety of the study and the accuracy of the data are ensured, thereby enabling a better assessment of the clinical efficacy of the new EasyStars catheter.
About this study
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.
Read the 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.
- Conditions
- Ventricular Tachycardia (VT), Atrial Tachycardia, Typical Atrial Flutter, Paroxysmal Atrial Fibrillation (PAF)
- Being tested
- EasyStars™ High Density Mapping Catheter
- Medical subject headings
- Tachycardia, Ventricular, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EasyStars™ High Density Mapping CatheterDevice
All patients underwent treatment for complex arrhythmias using EasyStars™ High Density Mapping Catheter.
| Study group | Role | What they receive |
|---|---|---|
| Patients of complex arrhythmias treated with EasyStars™ High Density Mapping Catheter | Experimental | Not described Receives: Device: EasyStars™ High Density Mapping Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary efficacy endpoint
The proportion of immediate success (all participating subjects) in treating rapid arrhythmias using EasyStars™ High Density Mapping Catheter in combination with cardiac ablation catheters and three-dimensional cardiac electrophysiology mapping systems
Measured: On the day of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start30 Aug 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia (VT)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
- Model description
- Multicentre, prospective, single-arm, non-randomised
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai General Hospital, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079813
- Sponsor's protocol ID
- XNZGQ01
- Acronym
- Rapid Arrhythm
- Status last verified
- Jan 2025
- First submitted
- 12 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficiency of Rapid Arrhythmia Mapping Using EasyStars™ High Density Mapping Catheter Applications
- ClinicalTrials.gov ID
- NCT07079813
- Acronym / sponsor ID
- Rapid Arrhythm / XNZGQ01
- Conditions
- Ventricular Tachycardia (VT), Atrial Tachycardia, Typical Atrial Flutter, Paroxysmal Atrial Fibrillation (PAF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai General Hospital, China
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jul 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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicentre, prospective, single-arm, non-randomised
| Arm | Type | Receives |
|---|---|---|
| Patients of complex arrhythmias treated with EasyStars™ High Density Mapping Catheter | Experimental | Device: EasyStars™ High Density Mapping Catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
Key exclusion criteria (23 listed)
- Clinical diagnosis: Atrial tachycardia (AT)
- Clinical diagnosis: atypical atrial flutter (AFL)
- Clinically diagnosed with paroxysmal atrial fibrillation (PAF)
- Clinical diagnosis: Persistent atrial fibrillation (PsAF)
- Presence of severe valvular heart disease or cardiomyopathy;
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 |
|---|---|---|
| EasyStars™ High Density Mapping CatheterAll patients underwent treatment for complex arrhythmias using EasyStars™ High Density Mapping Catheter. | Device | Patients of complex arrhythmias treated with EasyStars™ High Density Mapping Catheter |
Primary outcome
primary efficacy endpoint
Time frame: On the day of the surgery
The proportion of immediate success (all participating subjects) in treating rapid arrhythmias using EasyStars™ High Density Mapping Catheter in combination with cardiac ablation catheters and three-dimensional cardiac electrophysiology mapping systems
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 31 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EasyStars™ High Density Mapping Catheter in people with Ventricular Tachycardia (VT) and Atrial Tachycardia, run by Shanghai MicroPort EP MedTech Co., Ltd..
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 26 inclusion and 23 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 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary efficacy endpoint (time frame: On the day of the surgery). 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 31 Jul 2025.