AF - Atrial FibrillationCOBRANCT07883629
Comparison of Two Pulse Field Ablation Systems for AF Ablation
A study testing Pulse Field Ablation in people with AF - Atrial Fibrillation, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
This study randomizes patients undergoing PFA for A Fib to one of two standard care PFA systems. The patient will have an ICM placed to continuously monitor their heart rhythm. Follow up visits will occur until Month 36, and will include 12-lead ECG, ICM interrogation, AE updates, and QOL surveys. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- AF - Atrial Fibrillation
- What is being tested?
- Pulse Field Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2026to 30 May 2031
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic AF
- Persistent AF
- De novo AF ablation
- Males and Females Age 18 to 89 years of age, inclusive
- Willing and capable to provide informed consent
- Able and willing to participate in all examinations and follow-up visits and tests associated with this clinical study
Who cannot join
- AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
- Contraindication to, or unwillingness to use, systematic anticoagulation
- Left ventricular ejection fraction LVEF 30% as documented by TTE (within 3 months prior)
- Left atrial volume index >60 ml/m2
- LA anteroposterior dimension 5.5 cm
- Presence of intramural thrombus, tumor or other abnormality that precludes safe catheter introduction or manipulation
Show all 21Show fewer
- BMI >35 kg/m2
- Chronic renal insufficiency of <15 mL/min/1.73 m2 or any history of renal dialysis, or history of renal transplant
- Clinically significant systemic infection or sepsis
- Any of the following within the 3-months prior to enrollment:
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention
- Heart failure hospitalization
- Stroke or TIA
- Significant bleeding
- Pericarditis/effusions
- Left atrial thrombus
- Coronary artery bypass grafting/atriotomy within 6 months prior
- Contraindication for oral anticoagulation
- Organ or hematologic transplant, or currently being evaluated for an organ transplant Women who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Heather McDonald, MHA, CCRC, 412-359-3660, heather.mcdonald@ahn.org
Amit Thosani, MD
About this study
Official title: Comparative Efficacy, Safety, and Efficiency of SYSTEM 1 Versus SYSTEM 2 Pulse Field Ablation Systems for Atrial Fibrillation Ablation Randomized Controlled Trial
This study randomizes patients undergoing PFA for A Fib to one of two standard care PFA systems. The patient will have an ICM placed to continuously monitor their heart rhythm. Follow up visits will occur until Month 36, and will include 12-lead ECG, ICM interrogation, AE updates, and QOL surveys.
Read the detailed description
The purpose of this study is to compare the efficacy of de novo catheter ablation for persistent AF with System A versus System B pulse field ablation systems to reduce the incidence of AF/AFl/AT recurrence.
Single center, pilot, parallel group, two-arm, single-blind, randomized clinical trial 120 patients (60 per arm)
Subjects will be randomly assigned to one of two pulse field ablation (PFA) treatment procedures (A and B) that are commonly performed in patients with persistent, symptomatic atrial fibrillation The two procedures are performed the same way but using different cardiac catheters. Both of these procedures are performed routinely in the clinical setting.
- Ablation of your heart using a System A PFA system through a cardiac catheter B. Ablation of your heart using an System B PFA system inserted through a cardiac catheter To monitor the heart after the ablation, an implantable cardiac monitor (ICM) will be implanted under the skin of the subject's chest during the ablation procedure. The risks associated with the ICM device are movement under the skin, erosion of the skin over the device or tissue trauma, infection at the implantation site, and an allergic reaction to or rejection of the device.
- Conditions
- AF - Atrial Fibrillation
- Being tested
- Pulse Field Ablation
- Keywords
- Symptomatic AF, Persistent AF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Field AblationProcedure or surgery
Pulse Field Ablation
| Study group | Role | What they receive |
|---|---|---|
| PFA System A | Active comparator | Pulse Field System A through a standard ablation catheter Receives: Procedure: Pulse Field Ablation |
| PFA System B | Active comparator | Pulse Field System A through a standard ablation catheter Receives: Procedure: Pulse Field Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants free of AF, AFl, or AT recurrence
AF/AFl/AT Recurrence
Measured: 12 months
Secondary outcomes (2)
Number of participants free of AF, AFl, or AT recurrence
AF/AFl/AT Recurrence
Measured: 36 months
Number of participants free of repeat ablation
Repeat AF ablation within 12 months of randomization
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 posted20 Oct 2026
- Study start10 Jul 2026
- Primary completion30 Aug 2028 (estimated)
- Study completion30 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AF - 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
- Model description
- Comparison of two standard care treatments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Thosani, MD, Principal investigator, Allegheny Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883629
- Sponsor's protocol ID
- COBRA
- Acronym
- COBRA
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy, Safety, and Efficiency of SYSTEM 1 Versus SYSTEM 2 Pulse Field Ablation Systems for Atrial Fibrillation Ablation Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07883629
- Acronym / sponsor ID
- COBRA / COBRA
- Conditions
- AF - Atrial Fibrillation
- Keywords
- Symptomatic AF, Persistent AF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 May 2031 (estimated)
- First posted
- 20 Oct 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.
This study randomizes patients undergoing PFA for A Fib to one of two standard care PFA systems. The patient will have an ICM placed to continuously monitor their heart rhythm. Follow up visits will occur until Month 36, and will include 12-lead ECG, ICM interrogation, AE updates, and QOL surveys.
Detailed description
The purpose of this study is to compare the efficacy of de novo catheter ablation for persistent AF with System A versus System B pulse field ablation systems to reduce the incidence of AF/AFl/AT recurrence.
Single center, pilot, parallel group, two-arm, single-blind, randomized clinical trial 120 patients (60 per arm)
Subjects will be randomly assigned to one of two pulse field ablation (PFA) treatment procedures (A and B) that are commonly performed in patients with persistent, symptomatic atrial fibrillation The two procedures are performed the same way but using different cardiac catheters. Both of these procedures are performed routinely in the clinical setting.
- Ablation of your heart using a System A PFA system through a cardiac catheter B. Ablation of your heart using an System B PFA system inserted through a cardiac catheter To monitor the heart after the ablation, an implantable cardiac monitor (ICM) will be implanted under the skin of the subject's chest during the ablation procedure. The risks associated with the ICM device are movement under the skin, erosion of the skin over the device or tissue trauma, infection at the implantation site, and an allergic reaction to or rejection of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison of two standard care treatments.
| Arm | Type | Receives |
|---|---|---|
| PFA System A | Active comparator | Procedure: Pulse Field AblationPulse Field System A through a standard ablation catheter |
| PFA System B | Active comparator | Procedure: Pulse Field AblationPulse Field System A through a standard ablation catheter |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic AF
- Persistent AF
- De novo AF ablation
- Males and Females Age 18 to 89 years of age, inclusive
- Willing and capable to provide informed consent
Key exclusion criteria (21 listed)
- AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
- Contraindication to, or unwillingness to use, systematic anticoagulation
- Left ventricular ejection fraction LVEF 30% as documented by TTE (within 3 months prior)
- Left atrial volume index >60 ml/m2
- LA anteroposterior dimension 5.5 cm
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 |
|---|---|---|
| Pulse Field AblationPulse Field Ablation | Procedure or surgery | PFA System A, PFA System B |
Primary outcome
Number of participants free of AF, AFl, or AT recurrence
Time frame: 12 months
AF/AFl/AT Recurrence
2 secondary outcomes
Number of participants free of AF, AFl, or AT recurrence
Time frame: 36 months
Number of participants free of repeat ablation
Time frame: 12 months
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 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for AF - Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Amit Thosani, MD principal investigator
Allegheny Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse Field Ablation in people with AF - Atrial Fibrillation, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) 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 6 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 20 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 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?
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 Amit Thosani, MD (412-359-3457, amit.thosani@ahn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants free of AF, AFl, or AT recurrence (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 20 Oct 2026.