Chronic Atrial FibrillationNCT05393180
CONVERGE Post-Approval Study (PAS)
A study testing Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF in people with Chronic Atrial Fibrillation, run by AtriCure, Inc. at 13 sites in 2 countries.
Trial summary
The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Atrial Fibrillation
- What is being tested?
- Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 13 Apr 2022to 21 Nov 2028
- 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
- Age ≥ 18 years and < 80 years at time of enrollment consent;
- Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography [TTE] with parasternal 4 chamber view or equivalent imaging modality;
- Refractory or intolerant to at least one AAD (class I and/or III);
- Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue) longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines (> 12 months of continuous AF);
- Life expectancy > 12 months; and
- Provides written informed consent.
Who cannot join
- Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure;
- Left ventricular ejection fraction < 35%;
- Pregnant or planning to become pregnant during study;
- Co-morbid medical conditions that limit one-year life expectancy;
- Previous cardiac surgery;
- History of pericarditis;
Show all 20Show fewer
- Previous cerebrovascular accident (CVA), excluding fully resolved TIA;
- Patients who have active infection or sepsis
- Patients with esophageal ulcers strictures and varices;
- Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40);
- Patients who are contraindicated for anticoagulants such as heparin and coumadin;
- Patients who are being treated for ventricular arrhythmias;
- Patients who have had more than 2 prior left atrial catheter ablations for AF. NOTE: Note: Prior ablations should be limited to failed Pulmonary Vein Isolation (PVI) and no other left atrial lesions;
- Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment;
- Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative);
- Patient has presence of thrombus in the left atrium determined by intraoperative TEE;
- Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins >50 % stenosis;
- Planned Left Atrial Appendage Management (LAAM) with an endocardial implantable device during the course of the study;
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
- Presence of Barretts esophagitis
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Emory Saint Joseph Hopsital
Atlanta, Georgia, 30322
AtlantiCare Medical Center
Atlantic City, New Jersey, 08401
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
Baycare Health Systems
Clearwater, Florida, 33759
Hartford Hospital
Hartford, Connecticut, 06102
Norton Heart & Vascular Institute
Louisville, Kentucky, 40205
Wellstar Health System
Marietta, Georgia, 30062
Southcoast Hospitals Group
New Bedford, Massachusetts, 02740
Orlando Health
Orlando, Florida, 32806
University of Utah
Salt Lake City, Utah, 84112
Sutter Bay Hospitals
San Francisco, California, 94107
Avera Heart Hospital of SD
Sioux Falls, South Dakota, 57108
About this study
Official title: Hybrid Convergent of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Longstanding Persistent AF
The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.
Read the detailed description
In accordance with FDA's Guidance on Balancing Premarket and Post Market Data Collection for Devices Subject to Premarket Approval AtriCure proposes to conduct a post-approval study following the Agency's PMA approval of the CONVERGE pivotal trial.
Currently there are no FDA-approved treatment options available for patients diagnosed with drug refractory, long-standing persistent AF, which is known to increase the risk of stroke by five-fold.
The CONVERGE trial was conducted to address the treatment need in patients with advanced forms of AF, using a hybrid epicardial plus endocardial ablation approach. The Hybrid Convergent procedure and the EPi-Sense device have evolved over the past decade and now has a robust history of clinical use in approximately 10,000 patients.
The totality of evidence generated from the CONVERGE trial and published literature provides reasonable assurance of the safety and effectiveness of the Hybrid Convergent procedure for the treatment of longstanding-persistent AF, which AtriCure believes will facilitate evidence-based decision-making between physicians and patients in addressing this disease for which there are no treatment options.
A post-approval study synopsis is proposed herein to bolster the results of the CONVERGE pre-market pivotal study. Specifically, the aim of this study is to:
- Further confirm the effectiveness of the EPi-sense device in a larger sample size by narrowing confidence intervals.
- Demonstrate the proposed standard of care patient guidelines and mitigations for inflammatory pericardial effusions further reduce the observed safety event rates.
- Demonstrate that the CONVERGE pre-market pivotal study results are generalizable across operators with varying levels of experience.
Collect and report on long term outcomes of the Hybrid Convergent procedure.
- Conditions
- Chronic Atrial Fibrillation
- Being tested
- Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AFDevice
Epicardial linear lesions will be created endoscopically using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. Posterior and other linear lesions such as a roof lesion and mitral valve isthmus lesion will not be created during the endocardial component of the convergent procedure. This will be done endocardially using an irrigated endocardial ablation catheter.
Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation. .
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Convergent | Other | Once the procedure intra-op exclusion conditions have been evaluated, the Epicardial linear lesions will be created endoscopically using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. An endocardial ablation catheter will be used to complete the isolation of the pulmonary veins and create a cavotricuspid lesion to prevent typical atrial flutter.
Posterior and other linear lesions such as a roof lesion and mitral valve isthmus lesion will not be created during the endocardial component of the convergent procedure.
Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi-Sense®- Guided Coagulation System or EPi-Sense ST™ Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation. Receives: Device: Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from AF/AFL/AT >30 seconds through 12 months absent new or increased dose of class I/III AAD.
Primary Effectiveness Endpoint:
The primary effectiveness endpoint is defined as the number of participants that exhibit freedom from AF/AT/AFL absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 90-day blanking period through the 12-months post procedure follow-up visit.
The primary effectiveness endpoint will be evaluated based on the first 24 hours of the 7-days Holter monitoring.
Participants will be considered failures if any of the following conditions are observed: AF/AFL/AT greater than 30 seconds, new or increased dose of previously failed AAD through 12 month post procedure visit, Cardioversion through 12 months post procedure, left sided catheter ablation through 12 months post procedure and catheter ablation for right sided typical atrial flutter. Failures will be compared to total cohort to establish a success rate.
Measured: 1 year
Primary Safety Endpoint, Incidence of defined Major Adverse Events
The primary safety endpoint for the study is defined as the number of participants that exhibit device or procedure-related major adverse events (MAEs) for subjects undergoing the Hybrid Convergent procedure from the index procedure through 30-days post procedure. Participants will be considered failures if the following is exhibted:
- Pericardial effusions with cardiac tamponade defined as effusions resulting in hemodynamic compromise.
- Severe pulmonary vein (PV) stenosis
- Excessive bleeding requiring reoperation
- Myocardial infarction (MI);
- Stroke, transient ischemic attacks (TIA);
- Atrioesophageal fistula (AEF) through 3-months post-procedure;
- Phrenic nerve injury
- Death Failures will be compared to total cohort of participants to establish success rate.
Measured: 30-days post procedure
Secondary outcomes (9)
Incidence of significant pericardial effusion
- Number of participants that exhibit clinically significant pericardial effusions that require percutaneous or surgical treatment post-procedure. A significant pericardial effusion in one which results in hemodynamic compromise, requires elective or urgent pericardiocentesis, or results in 1 cm or more pericardial effusion as documented by echocardiography. Failures will be compared to total cohort of participants to establish success rate.
Measured: 12 months
Incidence of Serious Adverse Events (SAE) through 12 months
- Device and procedure-related serious adverse events reported through 12 months post-procedure
Measured: 12 months
Increase or decrease in AF symptoms from baseline
- Change in AF symptoms from baseline to 12-, 18-, 24- and 36- months post-procedure based on Quality of Life (QoL) assessment using The Atrial Fibrillation Effect on Quality-of-life Questionnaire ( AFEQT)
Measured: 3 years
Freedom from AF/AT/AFL >30 seconds with previously or intolerant failed class I/III AAD
- Freedom from AF/AT/AFL >30 seconds duration absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 90-day blanking period through the 12-months post procedure follow-up visit. Evaluated based on the first 24 hours of the 7-days Holter monitoring and symptom-driven event monitoring
Measured: 12 months
Freedom from any AF/AFL/AT >30 seconds without a Class I/III
- Freedom from any AF/AFL/AT >30 seconds duration without a Class I/III AAD prescribed for AF following the 90-day blanking period through 12- 18-, 24- and 36- months post-procedure
Measured: 3 years
Freedom from any AF/AFL/AT >30 seconds with or without a Class I/III AAD
- Freedom from any AF/AFL/AT >30 seconds duration with or without an AAD prescribed for AF following the 90-day blanking period through 12-, 18-, 24- and 36- months post -procedure
Measured: 3 years
Number of participants with a reduction of AF burden
- Residual AF burden / reduction in overall AF burden at 12-, 18-, 24- and 36-months post procedure when compared to baseline. No change or increase in burden will be considered a failure. Failures will be compared to total cohort of participants to establish success rate compared to baseline.
Measured: 3 years
Number of Participants with an decrease in AFEQT Questionnaire Quality of Life (Qol) Score
- Change in AF-specific Quality of Life (QoL) score(s) at 12-, 18-, 24- and 36- months post-index procedure when compared to baseline score. The increase in scores will be compared to baseline to determine comparative success or failure.
Measured: 3 years
Number of participants with less than 30 seconds of AF/AFL/AT
Freedom from AF/AFL/AT effectiveness secondary endpoints at 12-months will be evaluated from the 7-day rhythm recording and, also from the first 24 hours of a 7-days Holter. Freedom from AF/AFL/AT effectiveness secondary endpoints at 18-, 24- and 36- months will be evaluated from the 7-day rhythm recording. All burden effectiveness endpoints will be assessed from 7-days Holter for all subjects and separately for subjects with ILR/PPM data. Success or failure will be defined as AF/AFL/AT greater than 30 seconds duration. Failures will be compared to total cohort of participants to establish success rate.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start13 Apr 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion21 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center, open-label, single arm (Hybrid Convergent only) post-approval study
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393180
- Sponsor's protocol ID
- CP2021-1
- Status last verified
- Oct 2025
- First submitted
- 24 Jun 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Convergent of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Longstanding Persistent AF
- ClinicalTrials.gov ID
- NCT05393180
- Acronym / sponsor ID
- CP2021-1
- Conditions
- Chronic Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 21 Nov 2028 (estimated)
- First posted
- 26 May 2022 (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 primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.
Detailed description
In accordance with FDA's Guidance on Balancing Premarket and Post Market Data Collection for Devices Subject to Premarket Approval AtriCure proposes to conduct a post-approval study following the Agency's PMA approval of the CONVERGE pivotal trial.
Currently there are no FDA-approved treatment options available for patients diagnosed with drug refractory, long-standing persistent AF, which is known to increase the risk of stroke by five-fold.
The CONVERGE trial was conducted to address the treatment need in patients with advanced forms of AF, using a hybrid epicardial plus endocardial ablation approach. The Hybrid Convergent procedure and the EPi-Sense device have evolved over the past decade and now has a robust history of clinical use in approximately 10,000 patients.
The totality of evidence generated from the CONVERGE trial and published literature provides reasonable assurance of the safety and effectiveness of the Hybrid Convergent procedure for the treatment of longstanding-persistent AF, which AtriCure believes will facilitate evidence-based decision-making between physicians and patients in addressing this disease for which there are no treatment options.
A post-approval study synopsis is proposed herein to bolster the results of the CONVERGE pre-market pivotal study. Specifically, the aim of this study is to:
- Further confirm the effectiveness of the EPi-sense device in a larger sample size by narrowing confidence intervals.
- Demonstrate the proposed standard of care patient guidelines and mitigations for inflammatory pericardial effusions further reduce the observed safety event rates.
- Demonstrate that the CONVERGE pre-market pivotal study results are generalizable across operators with varying levels of experience.
Collect and report on long term outcomes of the Hybrid Convergent procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center, open-label, single arm (Hybrid Convergent only) post-approval study
| Arm | Type | Receives |
|---|---|---|
| Hybrid Convergent | Other | Device: Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AFOnce the procedure intra-op exclusion conditions have been evaluated, the Epicardial linear lesions will be created endoscopically using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. An endocardial ablation catheter will be used to complete the isolation of the pulmonary veins and create a cavotricuspid lesion to prevent typical atrial flutter. Posterior and other linear lesions such as a roof lesion and mitral valve isthmus lesion will not be created during the endocardial component of the convergent procedure. Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi-Sense®- Guided Coagulation System or EPi-Sense ST™ Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years and < 80 years at time of enrollment consent;
- Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography [TTE] with parasternal 4 chamber view or equivalent imaging modality;
- Refractory or intolerant to at least one AAD (class I and/or III);
- Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue) longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines (> 12 months of continuous AF);
- Life expectancy > 12 months; and
Key exclusion criteria (20 listed)
- Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure;
- Left ventricular ejection fraction < 35%;
- Pregnant or planning to become pregnant during study;
- Co-morbid medical conditions that limit one-year life expectancy;
- Previous cardiac surgery;
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 |
|---|---|---|
| Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AFEpicardial linear lesions will be created endoscopically using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. Posterior and other linear lesions such as a roof lesion and mitral valve isthmus lesion will not be created during the endocardial component of the convergent procedure. This will be done endocardially using an irrigated endocardial ablation catheter. Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation. . | Device | Hybrid Convergent |
Primary outcome
Freedom from AF/AFL/AT >30 seconds through 12 months absent new or increased dose of class I/III AAD.
Time frame: 1 year
Primary Effectiveness Endpoint: The primary effectiveness endpoint is defined as the number of participants that exhibit freedom from AF/AT/AFL absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 90-day blanking period through the 12-months post procedure follow-up visit. The primary effectiveness endpoint will be evaluated based on the first 24 hours of the 7-days Holter monitoring. Participants will be considered failures if any of the following conditions are observed: AF/AFL/AT greater than 30 seconds, new or increased dose of previously failed AAD through 12 month post procedure visit, Cardioversion through 12 months post procedure, left sided catheter ablation through 12 months post procedure and catheter ablation for right sided typical atrial flutter. Failures will be compared to total cohort to establish a success rate.
Primary Safety Endpoint, Incidence of defined Major Adverse Events
Time frame: 30-days post procedure
The primary safety endpoint for the study is defined as the number of participants that exhibit device or procedure-related major adverse events (MAEs) for subjects undergoing the Hybrid Convergent procedure from the index procedure through 30-days post procedure. Participants will be considered failures if the following is exhibted: * Pericardial effusions with cardiac tamponade defined as effusions resulting in hemodynamic compromise. * Severe pulmonary vein (PV) stenosis * Excessive bleeding requiring reoperation * Myocardial infarction (MI); * Stroke, transient ischemic attacks (TIA); * Atrioesophageal fistula (AEF) through 3-months post-procedure; * Phrenic nerve injury * Death Failures will be compared to total cohort of participants to establish success rate.
9 secondary outcomes
Incidence of significant pericardial effusion
Time frame: 12 months
Incidence of Serious Adverse Events (SAE) through 12 months
Time frame: 12 months
Increase or decrease in AF symptoms from baseline
Time frame: 3 years
Freedom from AF/AT/AFL >30 seconds with previously or intolerant failed class I/III AAD
Time frame: 12 months
Freedom from any AF/AFL/AT >30 seconds without a Class I/III
Time frame: 3 years
Freedom from any AF/AFL/AT >30 seconds with or without a Class I/III AAD
Time frame: 3 years
Number of participants with a reduction of AF burden
Time frame: 3 years
Number of Participants with an decrease in AFEQT Questionnaire Quality of Life (Qol) Score
Time frame: 3 years
Number of participants with less than 30 seconds of AF/AFL/AT
Time frame: 3 years
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 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF in people with Chronic Atrial Fibrillation, run by AtriCure, Inc. at 13 sites in 2 countries.
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 6 inclusion and 20 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, United Kingdom. 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?
Freedom from AF/AFL/AT >30 seconds through 12 months absent new or increased dose of class I/III AAD. (time frame: 1 year). The study lists 2 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 22 Apr 2026.