Persistant Atrial FibrillationQuick AFNCT07281521
Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation
A study testing pulsed field ablation in people with Persistant Atrial Fibrillation, run by CardioFocus at 3 sites in 2 countries.
Trial summary
The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Persistant Atrial Fibrillation
- What is being tested?
- pulsed field ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 27 Feb 2023to Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of recurrent symptomatic paroxysmal AF (PAF) or persistent AF (PerAF) with the following documentation:
- Paroxysmal AF (Phase A participants)
- Physician's note indicating symptoms consistent with recurrent symptomatic PAF AND
- At least one documented episode of AF captured continuously on 12-lead ECG, or for at least 30 seconds on transtelephonic monitor (TTM), Holter monitor, telemetry strip, or similar within 12 months prior to enrollment
- Persistent AF (Phase A, B, and C participants)
- Physician's note indicating symptoms consistent with recurrent symptomatic PerAF AND
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- Any 24-hour ECG recording of continuous AF within 12 months prior to enrollment OR
- Two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart within 12 months prior to enrollment OR
- History of ≥2 direct current cardioversion (DCCV) performed within 12 months prior to enrollment
- Failure or intolerance of at least one antiarrhythmic drug (AAD) (Class I - IV) for AF, as evidenced by recurrent symptomatic PerAF or intolerable side effects due to the AAD
- Age 18 through 75 years-old on the day of enrollment
- Patient is indicated for an ablation procedure according to society guidelines or study site practice
- Patient is willing and able to give informed consent and is willing, able, and committed to participate in baseline and follow-up evaluations for the full duration of the study
Who cannot join
- Long-standing persistent AF (continuous AF sustained > 1 year)
- AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
- Prior cardiac ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion, or valvular cardiac procedure)
- Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during study participation
- Presence of any permanent pacemaker, biventricular pacemaker, or implantable cardiac defibrillator (with or without biventricular pacing function) that cannot be programmed, per the manufacturer's recommendations, during the ablation procedure
- Patient cannot be removed from AADs for reasons other than AF, which includes participants with Wolff-Parkinson-White (WPW) Syndrome and participants with a history of ventricular tachycardia (VT)
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- Presence of any IVC filters
- Presence of an interatrial baffle or patch
- Presence of any pulmonary vein stents
- Pre-existing pulmonary vein stenosis
- Pre-existing hemidiaphragmatic paralysis
- Atrial or ventricular septal defect closure
- Atrial myxoma
- Presence of any mechanical or biologic prosthetic heart valve
- Hemodynamically significant valvular disease as determined by the Investigator
- History of pericarditis
- History of Rheumatic heart disease
- History of thromboembolic event within 6 months prior to Index Ablation Procedure or evidence of intracardiac thrombus at time of the Index Ablation Procedure
- Any of the following events within 3 months prior to the Index Ablation Procedure:
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention
- Heart surgery including coronary artery bypass grafting
- Heart failure hospitalization
- Cerebral ischemic event (stroke or transient ischemic attack (TIA))
- Clinically significant bleeding requiring surgical intervention
- Pericardial effusion
- Ventriculotomy or atriotomy
- New York Heart Association (NYHA) Class IV congestive heart failure
- Documented left ventricular ejection fraction (LVEF) ≤35% measured by acceptable cardiac testing (e.g., TTE, cardiac CT, etc.) within 6 months prior to enrollment
- Hypertrophic cardiomyopathy
- Primary pulmonary hypertension
- Significant or symptomatic hypotension
- Thrombocytosis, thrombocytopenia
- Contraindication to, or unwillingness to use, systemic anticoagulation
- Patient contraindicated for CT or MRI
- Sensitivity to contrast media not controlled by premedication
- Women known to be pregnant or breastfeeding, or any women of childbearing potential who are not on a reliable form of birth regulation method or abstinence
- Patient is participating in any other potentially confounding research
- Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or therapy, or confound data or is interpretation, including but not limited to:
- Solid organ or hematologic transplant, or currently being evaluated for organ transplant
- Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
- Chronic renal insufficiency with eGFR <50 mL/min/1.73 m2, any history of renal dialysis, or history of renal transplant
- Active malignancy or history of treated cancer within 24 months prior to enrollment
- History of severe esophageal ulcers, strictures, esophagitis, esophageal structural abnormality, and uncontrolled/untreated gastroesophageal reflux disease (GERD)
- Active systemic infection
- Clinically significant psychological condition that, in the Investigator's opinion, would prohibit the participant's ability to meet the protocol requirements
- Predicted life expectancy <1 year
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Safety & Effectiveness of the CardioWave Pulsed Field Ablation System With the QuickShot Nav Large-Area Focal Catheter for Ablation of Persistent Atrial Fibrillation
The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF).
Read the detailed description
This is a prospective, single-arm, multi-center, clinical study. The study will be conducted at up to 4 centers in Europe. Up to 200 participants will be enrolled and treated.
Participants enrolled in Phase A and Phase B will be exited from the study upon completion of the remapping procedure hospital discharge. Participants enrolled in Phase C will be followed through 12 months. All eligible patients who provide written informed consent will be treated with the study device.
- Conditions
- Persistant Atrial Fibrillation
- Being tested
- pulsed field ablation
- Keywords
- ablation, pulsed field ablation, 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.
pulsed field ablationDevice
pulsed field ablation with a large-area focal catheter
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Field Ablation Treatment | Experimental | The treatment arm will undergo catheter ablation for persistent atrial fibrillation with the PFA system with a Large-Area Focal Catheter Receives: Device: pulsed field ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint - Rate of Primary Serious Adverse Events
The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified:
- Atrio-esophageal fistula (assessed at ≥60 days)
- Cardiac perforation, tamponade, or pericardial effusion
- Cerebrovascular accident (CVA)/stroke
- Complete heart block
- Death
- Major vascular access complications/bleeding requiring surgical intervention or blood transfusion
- Myocardial infarction
- Pericarditis
- Phrenic nerve injury resulting in persistent diaphragmatic paralysis (assessed at ≥60 days)
- Pulmonary vein stenosis (assessed at ≥60 days)
- Thromboembolism
- Transient ischemic attack (TIA)
- Vagal nerve injury/gastroparesis
Measured: 7 days (unless otherwise specified)
Primary Effectiveness Endpoint - Acute Procedure Success
Percentage of treated pulmonary veins with documented PVI at the end of the index procedure using the study device only. Acute PVI will be assessed by the confirmation of entrance and/or exit block.
- Inability to isolate a targeted pulmonary vein with the study device and requiring use of a non-study ablation device to complete PVI will count as an acute procedure failure.
Measured: During procedure
Secondary outcomes (3)
Chronic PVI Durability
Percentage of treated pulmonary veins with documented PVI at the remapping procedure. Chronic PVI will be assessed by the confirmation of entrance and/or exit block for all pulmonary veins treated at the index procedure.
Measured: 60 days post-procedure
Acute Success of Additional Atrial Lesion Sets
Percentage of additional atrial lesion sets (PWI, CTI, mitral isthmus) with documented acute procedural success using the study device only.
Measured: During procedure
12-Month Freedom from Atrial Arrhythmia
Freedom from documented atrial arrhythmia (AF/AFL/AT) episodes ≥30 seconds duration, after the 60-day Blanking Period following the index ablation procedure, documented by trans-telephonic monitoring (TTM) or Holter monitor through 12 months follow-up.
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start27 Feb 2023
- Primary completionAug 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistant 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioFocus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281521
- Sponsor's protocol ID
- 25-6647
- Acronym
- Quick AF
- Status last verified
- Jul 2026
- First submitted
- 4 Dec 2025
- Last updated
- 3 Aug 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Effectiveness of the CardioWave Pulsed Field Ablation System With the QuickShot Nav Large-Area Focal Catheter for Ablation of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07281521
- Acronym / sponsor ID
- Quick AF / 25-6647
- Conditions
- Persistant Atrial Fibrillation
- Keywords
- ablation, pulsed field ablation, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CardioFocusIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Dec 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.
The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF).
Detailed description
This is a prospective, single-arm, multi-center, clinical study. The study will be conducted at up to 4 centers in Europe. Up to 200 participants will be enrolled and treated.
Participants enrolled in Phase A and Phase B will be exited from the study upon completion of the remapping procedure hospital discharge. Participants enrolled in Phase C will be followed through 12 months. All eligible patients who provide written informed consent will be treated with the study device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed Field Ablation Treatment | Experimental | Device: pulsed field ablationThe treatment arm will undergo catheter ablation for persistent atrial fibrillation with the PFA system with a Large-Area Focal Catheter |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of recurrent symptomatic paroxysmal AF (PAF) or persistent AF (PerAF) with the following documentation:
- Paroxysmal AF (Phase A participants)
- Persistent AF (Phase A, B, and C participants)
- Failure or intolerance of at least one antiarrhythmic drug (AAD) (Class I - IV) for AF, as evidenced by recurrent symptomatic PerAF or intolerable side effects due to the AAD
- Age 18 through 75 years-old on the day of enrollment
Key exclusion criteria (48 listed)
- Long-standing persistent AF (continuous AF sustained > 1 year)
- AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
- Prior cardiac ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion, or valvular cardiac procedure)
- Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during study participation
- Presence of any permanent pacemaker, biventricular pacemaker, or implantable cardiac defibrillator (with or without biventricular pacing function) that cannot be programmed, per the manufacturer's recommendations, during the ablation 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 |
|---|---|---|
| pulsed field ablationpulsed field ablation with a large-area focal catheter | Device | Pulsed Field Ablation Treatment |
Primary outcome
Primary Safety Endpoint - Rate of Primary Serious Adverse Events
Time frame: 7 days (unless otherwise specified)
The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified: * Atrio-esophageal fistula (assessed at ≥60 days) * Cardiac perforation, tamponade, or pericardial effusion * Cerebrovascular accident (CVA)/stroke * Complete heart block * Death * Major vascular access complications/bleeding requiring surgical intervention or blood transfusion * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in persistent diaphragmatic paralysis (assessed at ≥60 days) * Pulmonary vein stenosis (assessed at ≥60 days) * Thromboembolism * Transient ischemic attack (TIA) * Vagal nerve injury/gastroparesis
Primary Effectiveness Endpoint - Acute Procedure Success
Time frame: During procedure
Percentage of treated pulmonary veins with documented PVI at the end of the index procedure using the study device only. Acute PVI will be assessed by the confirmation of entrance and/or exit block. • Inability to isolate a targeted pulmonary vein with the study device and requiring use of a non-study ablation device to complete PVI will count as an acute procedure failure.
3 secondary outcomes
Chronic PVI Durability
Time frame: 60 days post-procedure
Acute Success of Additional Atrial Lesion Sets
Time frame: During procedure
12-Month Freedom from Atrial Arrhythmia
Time frame: 12 months post-procedure
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 3 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Persistant Atrial Fibrillation
Active, not recruiting
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
Atrial Fibrillation (AF), Persistant Atrial Fibrillation
Not yet recruitingPhase 2/3
Restoring Sinus Rhythm Using Dual-Shock Technique in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Atrial Fibrillation
Recruiting
Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Persistant Atrial Fibrillation
Not yet recruiting
The Effect of Pulse Field Ablation of Atrial Fibrillation Involving Posterior Wall Ablation on Atrial Mechancis Assessed by Cardiac Magnetic Resonance Imaging
Persistant Atrial Fibrillation, Paroxysmal 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed field ablation in people with Persistant Atrial Fibrillation, run by CardioFocus at 3 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 13 inclusion and 48 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 3 Aug 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 Czechia, Croatia. 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?
Primary Safety Endpoint - Rate of Primary Serious Adverse Events (time frame: 7 days (unless otherwise specified)). 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 3 Aug 2026.