Cardio Vascular DiseasezeroPSVTNCT07361055
The Best Workflow for Paroxysmal Supraventricular Tachycardia Ablation With Zero-fluoroscopy
A study testing Protocol A and Protocol B in people with Cardio Vascular Disease and Cryoablation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Primary Objective: To observe, record, and analyze the workflow and guidance system efficiency of these two surgical procedures, including placement time, location, and the number of successful placements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardio Vascular Disease, Cryoablation
- What is being tested?
- Protocol A and Protocol B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with documented PSVT on ECG. Twelve-lead is preferred. Single-lead is acceptable if recording quality is good enough for interpretation.
- Patients who are willing to sign the informed consent.
Who cannot join
- The patients had received PSVT ablation procedure before.
- Informed consent could not be obtained
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
Primary Objective: To observe, record, and analyze the workflow and guidance system efficiency of these two surgical procedures, including placement time, location, and the number of successful placements.
Secondary Objective: To compare the differences between the two procedures and observe and record the process of transitioning to intracardiac ultrasound guidance by experienced physicians performing both workflows. The primary focus is on the time spent on target steps and related complications, with the aim of reducing radiation exposure during the procedure with the new technology.
Read the detailed description
The aim of this study is to compare the safety and efficiency of two workflows (with or without FAM Dx) using CARTO® 3 System for PSVT ablation. The results will later be compared with another 3-dimentional mapping system (Ensite™) historically
- Conditions
- Cardio Vascular Disease, Cryoablation
- Being tested
- Protocol A, Protocol B
- Keywords
- zero-fluoroscopy, paroxysmal supraventricular tachycardia ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol ADevice
Also called FAM DX+, DECANAV®
Mapping with DECANAV
Protocol BDevice
Also called FAM DX-, NAVISTAR®
Mapping with NAVISTAR
| Study group | Role | What they receive |
|---|---|---|
| Protocol A (Fam DX+) | Experimental | Create geometry FAM Mapping with DECANAV(Fam DX+) Receives: Device: Protocol A |
| Protocol B (FAM DX-) | Active comparator | Create geometry FAM MAPPING WITH NAVISTAR (FAM DX-) Receives: Device: Protocol B |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of ablation
defined by elimination of accessory pathway and slow nodal pathway or modification of the slow nodal pathway with which a PSVT upto 3 reentrants would not be induced
Measured: 1Year
Secondary outcomes (1)
The complication rates
including the occurrence of AV block needing pacemaker, or pericardial effusion needing drainage, or use of fluoroscopy
Measured: 1Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start26 Mar 2025
- 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 Cardio Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361055
- Sponsor's protocol ID
- 202401199RIPB
- Acronym
- zeroPSVT
- Status last verified
- Mar 2025
- First submitted
- 6 Jan 2026
- Last updated
- 22 Jan 2026
- 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Best Workflow for Paroxysmal Supraventricular Tachycardia Ablation With Zero-fluoroscopy
- ClinicalTrials.gov ID
- NCT07361055
- Acronym / sponsor ID
- zeroPSVT / 202401199RIPB
- Conditions
- Cardio Vascular Disease, Cryoablation
- Keywords
- zero-fluoroscopy, paroxysmal supraventricular tachycardia ablation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jan 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.
Primary Objective: To observe, record, and analyze the workflow and guidance system efficiency of these two surgical procedures, including placement time, location, and the number of successful placements.
Secondary Objective: To compare the differences between the two procedures and observe and record the process of transitioning to intracardiac ultrasound guidance by experienced physicians performing both workflows. The primary focus is on the time spent on target steps and related complications, with the aim of reducing radiation exposure during the procedure with the new technology.
Detailed description
The aim of this study is to compare the safety and efficiency of two workflows (with or without FAM Dx) using CARTO® 3 System for PSVT ablation. The results will later be compared with another 3-dimentional mapping system (Ensite™) historically
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocol A (Fam DX+) | Experimental | Device: Protocol ACreate geometry FAM Mapping with DECANAV(Fam DX+) |
| Protocol B (FAM DX-) | Active comparator | Device: Protocol BCreate geometry FAM MAPPING WITH NAVISTAR (FAM DX-) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with documented PSVT on ECG. Twelve-lead is preferred. Single-lead is acceptable if recording quality is good enough for interpretation.
- Patients who are willing to sign the informed consent.
Key exclusion criteria (2 listed)
- The patients had received PSVT ablation procedure before.
- Informed consent could not be obtained
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 |
|---|---|---|
| Protocol AAlso: FAM DX+, DECANAV®Mapping with DECANAV | Device | Protocol A (Fam DX+) |
| Protocol BAlso: FAM DX-, NAVISTAR®Mapping with NAVISTAR | Device | Protocol B (FAM DX-) |
Primary outcome
The success of ablation
Time frame: 1Year
defined by elimination of accessory pathway and slow nodal pathway or modification of the slow nodal pathway with which a PSVT upto 3 reentrants would not be induced
1 secondary outcome
The complication rates
Time frame: 1Year
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 22 Jan 2026.
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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 Protocol A and Protocol B in people with Cardio Vascular Disease and Cryoablation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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 22 Jan 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 Taiwan. 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?
The success of ablation (time frame: 1Year). 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 22 Jan 2026.