Atrial FibrillationPVS-PVINCT06701292
Precision Ablation For Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) With Omnipolar Mapping Technology
A study testing PVS-PVI targeted ablation and Wide area circumferential ablation (WACA) in people with Atrial Fibrillation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare procedural times and Radiofrequency (RF)applications required for Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-PVI) , to compare the efficacy of PVS-PVI , to compare the safety of PVS-PVI and to assess other clinical outcomes of PVS-PVI in individuals… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PVS-PVI targeted ablation and Wide area circumferential ablation (WACA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Symptomatic paroxysmal AF refractory to at least one Class I or Class III antiarrhythmic medication, intolerance to antiarrhythmic medications, or a preference to not trial antiarrhythmic medications
- A minimum of one documented AF episode via 12-lead ECG, Holter monitor, or loop recorder
- Capability to provide informed consent
Who cannot join
- Persistent or permanent AF
- Prior history of catheter or surgical ablation for AF or left atrial ablation for atypical flutter
- Reversible causes of AF
- Congenital heart disease
- Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation)
- Pregnancy
Show all 9Show fewer
- Known presence of intracardiac thrombus
- Systemic oral anticoagulation therapy contraindicated, including a history of heparin-induced thrombocytopenia
- Broad vortex-like connections and no clear PVMS to be targeted
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Precision Ablation For Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves With Omnipolar Mapping Technology - A Randomized Pilot Trial
The purpose of this study is to compare procedural times and Radiofrequency (RF)applications required for Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-PVI) , to compare the efficacy of PVS-PVI , to compare the safety of PVS-PVI and to assess other clinical outcomes of PVS-PVI in individuals with symptomatic paroxysmal Atrial fibrillation (AF) using Omnipolar Technology with conventional Wide area circumferential ablation (WACA).
- Conditions
- Atrial Fibrillation
- Being tested
- PVS-PVI targeted ablation, Wide area circumferential ablation (WACA)
- Keywords
- Ablation, symptomatic paroxysmal 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.
PVS-PVI targeted ablationDevice
Omnipolar technology will be used to analyze all PVs and delineate the PVMS. Once identified, PVMS will be marked and described in a clockface fashion using a lateral view of the vein.Ablation will target the PVMS using the same power and force parameters as described for the WACA procedure. Effective ablation lesions and distance between ablation spots will be represented in the same manner too. Lesions should cover at least 5 mm outside the PVMS delineation on both PVMS borders of each myocardial sleeve. PVI will be demonstrated with the same technique described in the WACA procedure.
The PVI will be verified for each vein 10 minutes after the initial achievement of PVI.
Wide area circumferential ablation (WACA)Device
After generating the 3D electroanatomical map of the heart to understand where treatment needs to be applied,using a tool called radiofrequency (RF) ablation, small burns will be made around the veins to block abnormal electrical signals. Each burn is applied with up to 50 watts of power and lasts up to 10 seconds.The ablation tool will press down with a force of around 10-20 grams.The mapping system (NAVX software) shows the burns on the 3D map
| Study group | Role | What they receive |
|---|---|---|
| PVS-PVI | Experimental | Not described Receives: Device: PVS-PVI targeted ablation |
| WACA | Active comparator | Not described Receives: Device: Wide area circumferential ablation (WACA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of minutes taken from Initial puncture to transseptal access
Measured: From time of Initial puncture to time of transseptal access (an average of 10 minutes)
Number of minutes taken from transseptal access to left atrium 3D map completion
Measured: From time of transseptal access to time of left atrium 3D map completion (an average of 15 minutes)
Number of minutes taken from left atrium 3D map completion to when all pulmonary veins are isolated
Measured: From time of left atrium 3D map completion to time when all pulmonary veins are isolated (an average of 30-60 minutes)
Number of minutes with catheters in the left atrium
Measured: from time catheters are inserted to time catheters are removed (an average of 45-80 minutes)
Time from initial puncture till all sheaths removed
Measured: From time of initial puncture to time when all sheaths removed (an average of 90 minutes)
Total time of radiofrequency applications in seconds
Measured: from start of radiofrequency application to end of radiofrequency applications(an average of 300-900 seconds)
Number of radiofrequency applications used
Measured: end of procedure (an average of 1.5 hours after baseline)
Secondary outcomes (13)
Day and time to first recurrence of any documented atrial arrhythmias
This will be remotely monitored with the Internal loop recorder (ILR) monthly and in clinic every 3 months until the end of the follow up
Measured: an average of 91 days after catheter ablation
Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring
This will be remotely monitored with the ILR monthly and in clinic every 3 months until the end of the follow up
Measured: 3 months follow up
Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring
This will be remotely monitored with the ILR monthly and in clinic every 3 months until the end of the follow up
Measured: 6 months follow up
Number of Procedure-related complications
Complications include Atrio-esophageal fistula, Stroke or transient ischemic attack (TIA), Pericardial effusion/cardiac tamponade, PV stenosis , Vascular access-related complications , Diaphragmatic paralysis , other severe complications or other non-severe complications 0.37%
Measured: end of study (6 months after procedure)
Number of deaths
Measured: end of study (6 months after procedure)
Total radiation exposure dose
Measured: end of procedure (about 1.5 hours after start of procedure)
Number of participants that need a repeat catheter ablation procedure due to documented recurrence of symptomatic atrial arrhythmia
Measured: end of procedure till 6 months after procedure
Number of occurrences of any AF (symptomatic or asymptomatic) documented on ECG or ILR
Measured: during the first 90 days following catheter ablation.
Number of participants that visit the emergency room
Measured: end of procedure till 6 months after procedure
Number of participants that are hospitalized
Measured: end of procedure till 6 months after procedure
Number of incidences of stroke
Measured: end of procedure till 6 months after procedure
Change in quality of life as assessed by the Quality of Life (EQ-5D-5L) assessment
This is a 6 item questionnaire and the first 5 questions are each is scored from 1(no problem)-5(unable to) for a maximum score of 25, higher number indicating worse outcome. The 6th question is score on likert scale from 0(worst health you can imagine)-100(best health you can imagine), higher score indicating worse outcome
Measured: Baseline, 6 months after procedure
Number of participants that show a need for electrical cardioversion
Measured: end of procedure till 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start15 Jan 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Why it stopped: lack of recruitment after technological advances replaced the study procedure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramesh Hariharan, The University of Texas Health Science Center, Houston
- Investigators
- Ramesh Hariharan, D, MRCP,FACC, FHRS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701292
- Sponsor's protocol ID
- HSC-MS-24-0150
- Acronym
- PVS-PVI
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Ablation For Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves With Omnipolar Mapping Technology - A Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT06701292
- Acronym / sponsor ID
- PVS-PVI / HSC-MS-24-0150
- Conditions
- Atrial Fibrillation
- Keywords
- Ablation, symptomatic paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of recruitment after technological advances replaced the study procedure.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 22 Nov 2024 (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 purpose of this study is to compare procedural times and Radiofrequency (RF)applications required for Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-PVI) , to compare the efficacy of PVS-PVI , to compare the safety of PVS-PVI and to assess other clinical outcomes of PVS-PVI in individuals with symptomatic paroxysmal Atrial fibrillation (AF) using Omnipolar Technology with conventional Wide area circumferential ablation (WACA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVS-PVI | Experimental | Device: PVS-PVI targeted ablation |
| WACA | Active comparator | Device: Wide area circumferential ablation (WACA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic paroxysmal AF refractory to at least one Class I or Class III antiarrhythmic medication, intolerance to antiarrhythmic medications, or a preference to not trial antiarrhythmic medications
- A minimum of one documented AF episode via 12-lead ECG, Holter monitor, or loop recorder
- Capability to provide informed consent
Key exclusion criteria (9 listed)
- Persistent or permanent AF
- Prior history of catheter or surgical ablation for AF or left atrial ablation for atypical flutter
- Reversible causes of AF
- Congenital heart disease
- Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation)
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 |
|---|---|---|
| PVS-PVI targeted ablationOmnipolar technology will be used to analyze all PVs and delineate the PVMS. Once identified, PVMS will be marked and described in a clockface fashion using a lateral view of the vein.Ablation will target the PVMS using the same power and force parameters as described for the WACA procedure. Effective ablation lesions and distance between ablation spots will be represented in the same manner too. Lesions should cover at least 5 mm outside the PVMS delineation on both PVMS borders of each myocardial sleeve. PVI will be demonstrated with the same technique described in the WACA procedure. The PVI will be verified for each vein 10 minutes after the initial achievement of PVI. | Device | PVS-PVI |
| Wide area circumferential ablation (WACA)After generating the 3D electroanatomical map of the heart to understand where treatment needs to be applied,using a tool called radiofrequency (RF) ablation, small burns will be made around the veins to block abnormal electrical signals. Each burn is applied with up to 50 watts of power and lasts up to 10 seconds.The ablation tool will press down with a force of around 10-20 grams.The mapping system (NAVX software) shows the burns on the 3D map | Device | WACA |
Primary outcome
Number of minutes taken from Initial puncture to transseptal access
Time frame: From time of Initial puncture to time of transseptal access (an average of 10 minutes)
Number of minutes taken from transseptal access to left atrium 3D map completion
Time frame: From time of transseptal access to time of left atrium 3D map completion (an average of 15 minutes)
Number of minutes taken from left atrium 3D map completion to when all pulmonary veins are isolated
Time frame: From time of left atrium 3D map completion to time when all pulmonary veins are isolated (an average of 30-60 minutes)
Number of minutes with catheters in the left atrium
Time frame: from time catheters are inserted to time catheters are removed (an average of 45-80 minutes)
Time from initial puncture till all sheaths removed
Time frame: From time of initial puncture to time when all sheaths removed (an average of 90 minutes)
Total time of radiofrequency applications in seconds
Time frame: from start of radiofrequency application to end of radiofrequency applications(an average of 300-900 seconds)
Number of radiofrequency applications used
Time frame: end of procedure (an average of 1.5 hours after baseline)
13 secondary outcomes
Day and time to first recurrence of any documented atrial arrhythmias
Time frame: an average of 91 days after catheter ablation
Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring
Time frame: 3 months follow up
Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring
Time frame: 6 months follow up
Number of Procedure-related complications
Time frame: end of study (6 months after procedure)
Number of deaths
Time frame: end of study (6 months after procedure)
Total radiation exposure dose
Time frame: end of procedure (about 1.5 hours after start of procedure)
Number of participants that need a repeat catheter ablation procedure due to documented recurrence of symptomatic atrial arrhythmia
Time frame: end of procedure till 6 months after procedure
Number of occurrences of any AF (symptomatic or asymptomatic) documented on ECG or ILR
Time frame: during the first 90 days following catheter ablation.
Number of participants that visit the emergency room
Time frame: end of procedure till 6 months after procedure
Number of participants that are hospitalized
Time frame: end of procedure till 6 months after procedure
Number of incidences of stroke
Time frame: end of procedure till 6 months after procedure
Change in quality of life as assessed by the Quality of Life (EQ-5D-5L) assessment
Time frame: Baseline, 6 months after procedure
Number of participants that show a need for electrical cardioversion
Time frame: end of procedure till 6 months after procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
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. This study is not recruiting at the moment.
Ramesh Hariharan, D, MRCP,FACC, FHRS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVS-PVI targeted ablation and Wide area circumferential ablation (WACA) in people with Atrial Fibrillation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 28 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of minutes taken from Initial puncture to transseptal access (time frame: From time of Initial puncture to time of transseptal access (an average of 10 minutes)). The study lists 7 primary outcomes in all. 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 28 Jan 2026.