Persistent Atrial FibrillationARIADNE RCTNCT06747091
ARIADNE Clinical Trial
A study testing Catheter Ablation in people with Persistent Atrial Fibrillation, run by Stavros E Mountantonakis at 3 sites in United States.
Trial summary
A prospective multi-arm parallel group randomized clinical trial to compare the efficacy of three ablation strategies in patients with persistent atrial fibrillation using using a lattice-tip catheter that can switch between RFA and PFA energy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Catheter Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Mar 2025to 1 Mar 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
- 1. Symptomatic PerAF documented by
- (1a) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND electrocardiographic evidence
- 2. . Suitable candidate for catheter ablation.
- 3. . Adults aged 18 - 80 years.
- 4. . Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Who cannot join
- AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
- Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).
- Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
- Any carotid stenting or endarterectomy.
- Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.
- Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.
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- Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.
- Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.
- Documented left atrial thrombus on imaging.
- History of blood clotting or bleeding abnormalities.
- Any condition contraindicating chronic anticoagulation.
- Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
- Body mass index >40 kg/m2.
- Left atrial diameter >55 mm (anterioposterior).
- Diagnosed atrial myxoma.
- Uncontrolled heart failure or NYHA Class III or IV heart failure.
- Rheumatic heart disease.
- Hypertrophic cardiomyopathy.
- Unstable angina.
- Moderate to severe mitral valve stenosis.
- Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
- Primary pulmonary hypertension.
- Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
- Renal failure requiring dialysis.
- History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention.
- Acute illness, active systemic infection, or sepsis.
- Contraindication to both computed tomography and magnetic resonance angiography.
- Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical study results.
- Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.
- Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
- Known drug or alcohol dependency.
- Life expectancy less than 12 months.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
North Shore University Hospital
Manhasset, New York, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Kristie Coleman
New York, New York, 10075
About this study
Official title: Adjuvant Ablation for PeRsistent AtrIal FibrillAtion Using Dual ENergy LatticE Tip Catheter: ARIADNE-Randomized Clinical Trial
A prospective multi-arm parallel group randomized clinical trial to compare the efficacy of three ablation strategies in patients with persistent atrial fibrillation using using a lattice-tip catheter that can switch between RFA and PFA energy. The incremental benefit of posterior wall isolation (PWI) and mitral isthmus ablation may contribute to greater freedom from atrial fibrillation at twelve months.
Read the detailed description
This is a prospective randomized clinical trial. Patients will undergo catheter ablation for persistent AF using a lattice-tip catheter that can switch between RFA and PFA energy. Enrolled patients will be randomized to one of three ablation strategies:
- Pulmonary vein isolation using PFA energy
- Pulmonary vein isolation and posterior wall isolation using PFA energy
- Pulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy.
Patients will receive an implantable loop recorder prior to, during or post index ablation procedure for continuous monitoring for clinical recurrence of AF/AT/AFL
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Catheter Ablation
- Keywords
- Pulsed Field Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationProcedure or surgery
This is a prospective randomized clinical trial. Patients will undergo catheter ablation for persistent AF using a lattice-tip catheter that can switch between RFA and PFA energy. Enrolled patients will be randomized to one of three ablation strategies:
| Study group | Role | What they receive |
|---|---|---|
| PVI using PFA energy | Active comparator | Pulmonary vein isolation using PFA energy Receives: Procedure: Catheter Ablation |
| PVI and posterior wall isolation using PFA energy | Active comparator | Pulmonary vein isolation and posterior wall isolation using PFA energy Receives: Procedure: Catheter Ablation |
| PVI and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy. | Active comparator | Pulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy. Receives: Procedure: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects free from primary effectiveness failure
The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) lasting >2 minutes based on electrocardiographic data through 12-month follow-up and excluding a 60-day blanking period.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start18 Mar 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stavros E Mountantonakis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stavros E Mountantonakis, Northwell Health
- Investigators
- Stavros Mountantonakis, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747091
- Sponsor's protocol ID
- 24-0935-LHH
- Acronym
- ARIADNE RCT
- Status last verified
- Oct 2026
- First submitted
- 4 Nov 2024
- Last updated
- 29 Oct 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Ablation for PeRsistent AtrIal FibrillAtion Using Dual ENergy LatticE Tip Catheter: ARIADNE-Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06747091
- Acronym / sponsor ID
- ARIADNE RCT / 24-0935-LHH
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Pulsed Field Ablation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stavros E MountantonakisUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 24 Dec 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.
A prospective multi-arm parallel group randomized clinical trial to compare the efficacy of three ablation strategies in patients with persistent atrial fibrillation using using a lattice-tip catheter that can switch between RFA and PFA energy. The incremental benefit of posterior wall isolation (PWI) and mitral isthmus ablation may contribute to greater freedom from atrial fibrillation at twelve months.
Detailed description
This is a prospective randomized clinical trial. Patients will undergo catheter ablation for persistent AF using a lattice-tip catheter that can switch between RFA and PFA energy. Enrolled patients will be randomized to one of three ablation strategies:
- Pulmonary vein isolation using PFA energy
- Pulmonary vein isolation and posterior wall isolation using PFA energy
- Pulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy.
Patients will receive an implantable loop recorder prior to, during or post index ablation procedure for continuous monitoring for clinical recurrence of AF/AT/AFL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PVI using PFA energy | Active comparator | Procedure: Catheter AblationPulmonary vein isolation using PFA energy |
| PVI and posterior wall isolation using PFA energy | Active comparator | Procedure: Catheter AblationPulmonary vein isolation and posterior wall isolation using PFA energy |
| PVI and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy. | Active comparator | Procedure: Catheter AblationPulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Symptomatic PerAF documented by
- (1a) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND electrocardiographic evidence
- 2. . Suitable candidate for catheter ablation.
- 3. . Adults aged 18 - 80 years.
- 4. . Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Key exclusion criteria (32 listed)
- AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
- Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).
- Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
- Any carotid stenting or endarterectomy.
- Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.
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 |
|---|---|---|
| Catheter AblationThis is a prospective randomized clinical trial. Patients will undergo catheter ablation for persistent AF using a lattice-tip catheter that can switch between RFA and PFA energy. Enrolled patients will be randomized to one of three ablation strategies: | Procedure or surgery | PVI and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy., PVI and posterior wall isolation using PFA energy, PVI using PFA energy |
Primary outcome
Percent of subjects free from primary effectiveness failure
Time frame: 12 Months
The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) lasting >2 minutes based on electrocardiographic data through 12-month follow-up and excluding a 60-day blanking period.
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 29 Oct 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. This study is not recruiting at the moment.
Stavros Mountantonakis, MD principal investigator
Northwell Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter Ablation in people with Persistent Atrial Fibrillation, run by Stavros E Mountantonakis at 3 sites 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 5 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Percent of subjects free from primary effectiveness failure (time frame: 12 Months). 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 29 Oct 2026.