Atrial Fibrillation (AF)PVI-TZM-AFNCT06930599
Circumferential Pulmonary Vein Isolation Plus Transition Zone Modification in Atrial Fibrillation Patients Without Low-Voltage Areas
A study testing Pulmonary vein isolation plus transition zone modification and Pulmonary vein isolation alone in people with Atrial Fibrillation (AF), run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
This study investigates two treatments for atrial fibrillation (AF) patients without low-voltage-areas (LVAs). It aims to determine whether adding transition zone modification (TZM) to the pulmonary vein isolation (PVI) improves long-term outcomes compared to PVI alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Pulmonary vein isolation plus transition zone modification and Pulmonary vein isolation alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 9 Apr 2025to 9 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years AF referring for ablation No prior history of AF Absence of low-voltage areas during substrate mapping Presence of transition zone during substrate mapping Sign informed consent
Who cannot join
- Presence of left atrial thrombus Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease Untreated hypothyroidism or hyperthyroidism Dialysis-dependent terminal renal failure Life expectancy <12 months due to non-cardiovascular causes. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study Female under pregnancy or breast-feeding Involved in other studies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Pulmonary Vein Isolation With and Without Transitional Zone Modification in Atrial Fibrillation Patients Without Low-Voltage Areas
This study investigates two treatments for atrial fibrillation (AF) patients without low-voltage-areas (LVAs). It aims to determine whether adding transition zone modification (TZM) to the pulmonary vein isolation (PVI) improves long-term outcomes compared to PVI alone.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Pulmonary vein isolation plus transition zone modification, Pulmonary vein isolation alone
- Keywords
- Pulmonary vein isolation, Transition Zone Modification, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolation plus transition zone modificationProcedure or surgery
For those who are randomized to PVI+TZM arm, additional TZM should be performed after finishing PVI ablation. PVI could be performed using open-irrigated contact-force catheter.
Pulmonary vein isolation aloneProcedure or surgery
In periprocedural period, all antiarrhythmic drugs were discontinued for at least 5 half-lives and amiodarone for 2 months before the procedure. An electrophysiological study was performed after overnight fasting and mild sedated state with administration of intravenous midazolam and fentanyl. PVI should be performed under the CARTO or Ensite electroanatomic mapping system using an open-irrigated contact-force ablation catheter.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: PVI-alone arm | Active comparator | Not described Receives: Procedure: Pulmonary vein isolation alone |
| Experimental: PVI+TZM arm | Experimental | Not described Receives: Procedure: Pulmonary vein isolation plus transition zone modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From AF and/or ATs With or Without Antiarrhythmic Drugs (AADs)
Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts > 30 seconds.
Measured: at least 12 months follow up
Secondary outcomes (4)
Incidence of Peri-procedural Complications
Incidence of Peri-procedural Complications：stroke, cardiac perforation, PV stenosis, esophageal injury and death
Measured: 1 week after patient enrollment
Total procedure time
time that the patient spend in the procedure room
Measured: 1 week after patient enrollment
Total fluoroscopic time
the total fluoroscopy time, during PVI alone or PVI plus low-voltage substrate modification
Measured: 1 week after patient enrollment
Total RF delivery time
The cumulative duration (in minutes) of active radiofrequency (RF) energy application to the atrial tissue during the ablation procedure.
Measured: 1 week after patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start9 Apr 2025 (estimated)
- Primary completion9 Oct 2026 (estimated)
- Study completion9 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minglong Chen, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930599
- Sponsor's protocol ID
- 2024-SR-1134
- Acronym
- PVI-TZM-AF
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pulmonary Vein Isolation With and Without Transitional Zone Modification in Atrial Fibrillation Patients Without Low-Voltage Areas
- ClinicalTrials.gov ID
- NCT06930599
- Acronym / sponsor ID
- PVI-TZM-AF / 2024-SR-1134
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Pulmonary vein isolation, Transition Zone Modification, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 9 Apr 2025 (estimated)
- Primary completion
- 9 Oct 2026 (estimated)
- Study completion
- 9 Oct 2026 (estimated)
- First posted
- 16 Apr 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.
This study investigates two treatments for atrial fibrillation (AF) patients without low-voltage-areas (LVAs). It aims to determine whether adding transition zone modification (TZM) to the pulmonary vein isolation (PVI) improves long-term outcomes compared to PVI alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: PVI-alone arm | Active comparator | Procedure: Pulmonary vein isolation alone |
| Experimental: PVI+TZM arm | Experimental | Procedure: Pulmonary vein isolation plus transition zone modification |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 to 80 years AF referring for ablation No prior history of AF Absence of low-voltage areas during substrate mapping Presence of transition zone during substrate mapping Sign informed consent
Key exclusion criteria (1 listed)
- Presence of left atrial thrombus Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease Untreated hypothyroidism or hyperthyroidism Dialysis-dependent terminal renal failure Life expectancy <12 months due to non-cardiovascular causes. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study Female under pregnancy or breast-feeding Involved in other studies
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 |
|---|---|---|
| Pulmonary vein isolation plus transition zone modificationFor those who are randomized to PVI+TZM arm, additional TZM should be performed after finishing PVI ablation. PVI could be performed using open-irrigated contact-force catheter. | Procedure or surgery | Experimental: PVI+TZM arm |
| Pulmonary vein isolation aloneIn periprocedural period, all antiarrhythmic drugs were discontinued for at least 5 half-lives and amiodarone for 2 months before the procedure. An electrophysiological study was performed after overnight fasting and mild sedated state with administration of intravenous midazolam and fentanyl. PVI should be performed under the CARTO or Ensite electroanatomic mapping system using an open-irrigated contact-force ablation catheter. | Procedure or surgery | Active Comparator: PVI-alone arm |
Primary outcome
Freedom From AF and/or ATs With or Without Antiarrhythmic Drugs (AADs)
Time frame: at least 12 months follow up
Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts > 30 seconds.
4 secondary outcomes
Incidence of Peri-procedural Complications
Time frame: 1 week after patient enrollment
Total procedure time
Time frame: 1 week after patient enrollment
Total fluoroscopic time
Time frame: 1 week after patient enrollment
Total RF delivery time
Time frame: 1 week after patient enrollment
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 16 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation plus transition zone modification and Pulmonary vein isolation alone in people with Atrial Fibrillation (AF), run by The First Affiliated Hospital with Nanjing Medical University.
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 1 inclusion and 1 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 16 Apr 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?
Contact Yue Qiu, M.D. (+86-13057657758, qiuyue@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From AF and/or ATs With or Without Antiarrhythmic Drugs (AADs) (time frame: at least 12 months 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 16 Apr 2025.