Premature Ventricular ContractionsCHU-VANCT07503769
CHU Dual-Energy Ablation in Ventricular Arrhythmia
A study testing ablation in people with Premature Ventricular Contractions and Ventricular Tachycardia, run by Shanghai MicroPort EP MedTech Co., Ltd. at 1 site in China.
Trial summary
The objective of this study is to evaluate the safety of the dual-energy ablation catheter manufactured by Shanghai MicroPort EP Medical Technology Co., Ltd. in the treatment of tachyarrhythmias. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Premature Ventricular Contractions, Ventricular Tachycardia
- What is being tested?
- ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2026to 31 Oct 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age ≥ 18 years and ≤ 75 years；
- Clinically diagnosed with tachyarrhythmia, specifically idiopathic ventricular arrhythmia；
- Recurrent disease with obvious symptoms prior to enrollment;
- Failure to respond to or intolerance of at least one antiarrhythmic drug;
- Fully understand the treatment plan, voluntarily sign the informed consent form, and agree to undergo the examinations, procedures and follow-up as required by the protocol.
Who cannot join
- Left ventricular ejection fraction (LVEF) ≤ 40%
- History of ventricular flutter or ventricular fibrillation
- Diagnosis of long QT syndrome or arrhythmogenic cardiomyopathy
- Presence of structural heart disease or organic heart disease, including hypertrophic cardiomyopathy, dilated cardiomyopathy, ischemic cardiomyopathy, rheumatic heart disease, and congenital heart disease
- Previous atrial septal repair or atrial myxoma
- Carrying an active implantable device in the body (e.g., cardiac pacemaker, ICD, etc.)
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- NYHA functional class Ⅲ-Ⅳ
- Patients with documented cerebrovascular disease within the past 6 months (including cerebral hemorrhage, stroke, transient ischemic attack)
- Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting, prosthetic valve replacement or repair, atrial or ventricular incision)
- Patients with acute or severe systemic infection
- Patients with severe hepatic or renal disease, malignant tumor, or end-stage disease, who, in the investigator's judgment, may interfere with the treatment, evaluation, or compliance of this trial
- Patients with significant bleeding tendency, hypercoagulable state, or severe hematological disorders
- Patients who have participated in or are currently participating in other clinical trials within 3 months prior to enrollment
- Patients with other conditions deemed inappropriate for participation in this trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Contact-Force Guided Hybrid-Dual-Energy Ultra-Saline-Irrigated Ablation First-in-Man for Ventricular Arrhythmia: CHU VA
The objective of this study is to evaluate the safety of the dual-energy ablation catheter manufactured by Shanghai MicroPort EP Medical Technology Co., Ltd. in the treatment of tachyarrhythmias.
- Being tested
- ablation
- Keywords
- PVCs, VT
- Medical subject headings
- Ventricular Premature Complexes, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablationDevice
Also called Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter
All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter.
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation | Experimental | All enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter. Receives: Device: ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of catheter ablation
The primary efficacy endpoints were to evaluate the acute and 3-month follow-up success rate after ablation
Measured: at end of the procedure, 1-month follow-up, 3-month follow-up
Secondary outcomes (1)
Immediate success rate of ablation
It is defined as the disappearance of the identical outflow tract ventricular arrhythmia that was present pre-ablation, with no inducible sustained identical outflow tract ventricular arrhythmia during 20 minutes of observation following pharmacological and/or electrophysiological stimulation.
Measured: immediate ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start3 Feb 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular ContractionsStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503769
- Sponsor's protocol ID
- 775102
- Acronym
- CHU-VA
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This trial protocol is available in Chinese only and has not yet been translated into English.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact-Force Guided Hybrid-Dual-Energy Ultra-Saline-Irrigated Ablation First-in-Man for Ventricular Arrhythmia: CHU VA
- ClinicalTrials.gov ID
- NCT07503769
- Acronym / sponsor ID
- CHU-VA / 775102
- Keywords
- PVCs, VT
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 31 Mar 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 objective of this study is to evaluate the safety of the dual-energy ablation catheter manufactured by Shanghai MicroPort EP Medical Technology Co., Ltd. in the treatment of tachyarrhythmias.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation | Experimental | Device: ablationAll enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient age ≥ 18 years and ≤ 75 years；
- Clinically diagnosed with tachyarrhythmia, specifically idiopathic ventricular arrhythmia；
- Recurrent disease with obvious symptoms prior to enrollment;
- Failure to respond to or intolerance of at least one antiarrhythmic drug;
- Fully understand the treatment plan, voluntarily sign the informed consent form, and agree to undergo the examinations, procedures and follow-up as required by the protocol.
Key exclusion criteria (14 listed)
- Left ventricular ejection fraction (LVEF) ≤ 40%
- History of ventricular flutter or ventricular fibrillation
- Diagnosis of long QT syndrome or arrhythmogenic cardiomyopathy
- Presence of structural heart disease or organic heart disease, including hypertrophic cardiomyopathy, dilated cardiomyopathy, ischemic cardiomyopathy, rheumatic heart disease, and congenital heart disease
- Previous atrial septal repair or atrial myxoma
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 |
|---|---|---|
| ablationAlso: Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation CatheterAll enrolled subjects will undergo radiofrequency or pulsed ablation for idiopathic ventricular arrhythmias using the investigational catheter. | Device | Catheter ablation |
Primary outcome
Success rate of catheter ablation
Time frame: at end of the procedure, 1-month follow-up, 3-month follow-up
The primary efficacy endpoints were to evaluate the acute and 3-month follow-up success rate after ablation
1 secondary outcome
Immediate success rate of ablation
Time frame: immediate ablation
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 Mar 2026.
- Individual participant dataSharing planned: Undecided. This trial protocol is available in Chinese only and has not yet been translated into English.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ablation in people with Premature Ventricular Contractions and Ventricular Tachycardia, run by Shanghai MicroPort EP MedTech Co., Ltd. at 1 site 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 14 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: enrolling by invitation, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Success rate of catheter ablation (time frame: at end of the procedure, 1-month follow-up, 3-month follow-up). 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 Mar 2026.