Paroxysmal Atrial Fibrillation (PAF)NEXT PULSENCT07575828
Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation
A study testing PulseSelect Pulse Field Ablation (PFA) System in people with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions.
Trial summary
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with the PulseSelect PFA System. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
- What is being tested?
- PulseSelect Pulse Field Ablation (PFA) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2029
- 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
- Adults who are ≥18 and ≤80 years of age on the day of enrollment (or older than 18 if required by local law)
- A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
- Symptomatic paroxysmal AF: AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:
- Physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 12 months prior to enrollment; AND
- at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment.
- Symptomatic persistent AF: Continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
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- Physician's note indicating at least 1 symptomatic persistent AF episode occurring within 12 months prior to enrollment; AND
- any 24-hour continuous ECG recording documenting continuous AF within 12 months prior to enrollment; OR 2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 12 months prior to enrollment
- Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Who cannot join
- Long-standing persistent AF (continuous AF that is sustained >12 months)
- Paroxysmal AF patients: AF that required three (3) or more distinct cardioversions in the preceding 12 months.
- Paroxysmal AF: LA anteroposterior diameter > 5.0 cm (by MRI, CT, or TTE) Persistent AF: LA anteroposterior diameter > 5.5 cm (by MRI, CT, or TTE)
- Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
- Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
- Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
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- Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
- Contraindication to or unwillingness to use systemic anticoagulation
- Presence of any pulmonary vein stents
- Known pre-existing pulmonary vein stenosis
- Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy
- Moderate to severe mitral valve or aortic stenosis
- Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR)
- Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
- Unstable angina
- NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD)
- Severe lung disease, primary pulmonary hypertension, or any lung disease abnormal blood gases or requiring supplemental oxygen
- Rheumatic heart disease
- Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
- Documented left atrial thrombus on imaging
- Active systemic infection or sepsis
- Hypertrophic cardiomyopathy
- Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
- Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
- Carotid stenting or endarterectomy
- History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
- Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
- Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
- Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
- Known allergies or hypersensitivities to adhesives
- Body mass index > 40 kg/m2
- Atrial myxoma
- Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
- Renal insufficiency with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, or any history of renal failure requiring dialysis or renal transplant
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
- Known drug or alcohol dependency
- 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 trial results
- Amyloid heart disease (cardiac amyloidosis)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation (NEXT PULSE)
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with the PulseSelect PFA System.
Read the detailed description
This study will include subjects with a diagnosis of recurrent symptomatic Paroxysmal and Persistent AF. Following the index ablation procedure and hospital discharge, all study subjects will be followed at 7 days, 2 months, 6 months, and 12 months and will be exited from the study at the conclusion of the 12-month follow-up visit.
- Being tested
- PulseSelect Pulse Field Ablation (PFA) System
- Keywords
- Atrial Fibrillation (AF), Paroxysmal AF, Persistent AF, Symptomatic recurrent AF, Arrhythmia, PulseSelect PFA System, Pulsed Field Ablation, Catheter ablation, Pulmonary Vein Ablation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulseSelect Pulse Field Ablation (PFA) SystemDevice
Adult subjects with recurrent symptomatic paroxysmal AF or persistent AF will be enrolled and undergo ablation with the PulseSelect™ PFA system.
| Study group | Role | What they receive |
|---|---|---|
| AF ablation | Experimental | AF Ablation using the PulseSelect Pulse Field Ablation (PFA) System Receives: Device: PulseSelect Pulse Field Ablation (PFA) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of Participants with at Least One Primary Safety Event
Primary Safety events are:
Within 7 days of ablation procedure:
- Heart block requiring a pacemaker
- Major bleeding requiring transfusion
- Myocardial infarction
- Permanent phrenic nerve paralysis
- Pulmonary edema
- Severe pericarditis
- Significant pericardial effusion/tamponade
- Stroke/cerebrovascular accident (CVA)
- Systemic/pulmonary embolism requiring intervention
- Transient ischemic attack (TIA)
- Vagal nerve injury resulting in esophageal dysmotility or gastroparesis
- Vascular access complications requiring intervention
- Acute Kidney Injury (AKI) requiring dialysis, new hospitalization greater than 48 hours, or prolongation of hospitalization greater than 48 hours beyond the expected discharge
- Death
Within 3 months post-ablation:
- Atrioesophageal fistula/Esophageal perforation (procedure and PulseSelect PFA Loop Catheter related)
Within 6 months post-ablation:
- Pulmonary vein stenosis (≥70% diameter reduction)
Measured: Up to 6 months post procedure
Effectiveness: Number of Participants with Treatment Success
Treatment success is defined as freedom from documented recurrence of AF, AT, or AFL based on electrocardiographic data up to the 12-month follow-up and excluding a 90-day blanking period.
Treatment failure is defined as any of the following components:
- Acute procedural failure (see definition below)
- Documented AF/AT/AFL after the 90-day post-ablation blanking period
- Any subsequent AF catheter or surgical ablation in the LA, including repeat PVI ablation at any time during the study.
- Direct current cardioversion for AF/AT/AFL recurrences after the 90-day blanking period.
- Use of a Class I or III AAD at a higher daily dose than the pre-ablation maximum daily dose after the 90-day blanking period.
- Initiation of a new Class I or III AAD after the 90-day blanking period.
- Re-initiation after the 90-day blanking period of any dose of a Class I or III AAD that was failed or was not tolerated prior to the ablation procedure.
Measured: Up to 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 posted8 May 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial Fibrillation (PAF)Studies 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Andrade, Prof., Principal investigator, Vancouver General HospitalGerhard Hindricks, Prof., Principal investigator, German Heart Center Charite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575828
- Sponsor's protocol ID
- MDT25021
- Acronym
- NEXT PULSE
- Status last verified
- Apr 2026
- First submitted
- 4 May 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation (NEXT PULSE)
- ClinicalTrials.gov ID
- NCT07575828
- Acronym / sponsor ID
- NEXT PULSE / MDT25021
- Keywords
- Atrial Fibrillation (AF), Paroxysmal AF, Persistent AF, Symptomatic recurrent AF, Arrhythmia, PulseSelect PFA System, Pulsed Field Ablation, Catheter ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 8 May 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.
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with the PulseSelect PFA System.
Detailed description
This study will include subjects with a diagnosis of recurrent symptomatic Paroxysmal and Persistent AF. Following the index ablation procedure and hospital discharge, all study subjects will be followed at 7 days, 2 months, 6 months, and 12 months and will be exited from the study at the conclusion of the 12-month follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AF ablation | Experimental | Device: PulseSelect Pulse Field Ablation (PFA) SystemAF Ablation using the PulseSelect Pulse Field Ablation (PFA) System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults who are ≥18 and ≤80 years of age on the day of enrollment (or older than 18 if required by local law)
- A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
- Symptomatic paroxysmal AF: AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:
- Symptomatic persistent AF: Continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
- Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Key exclusion criteria (39 listed)
- Long-standing persistent AF (continuous AF that is sustained >12 months)
- Paroxysmal AF patients: AF that required three (3) or more distinct cardioversions in the preceding 12 months.
- Paroxysmal AF: LA anteroposterior diameter > 5.0 cm (by MRI, CT, or TTE) Persistent AF: LA anteroposterior diameter > 5.5 cm (by MRI, CT, or TTE)
- Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
- Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
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 |
|---|---|---|
| PulseSelect Pulse Field Ablation (PFA) SystemAdult subjects with recurrent symptomatic paroxysmal AF or persistent AF will be enrolled and undergo ablation with the PulseSelect™ PFA system. | Device | AF ablation |
Primary outcome
Safety: Number of Participants with at Least One Primary Safety Event
Time frame: Up to 6 months post procedure
Primary Safety events are: Within 7 days of ablation procedure: * Heart block requiring a pacemaker * Major bleeding requiring transfusion * Myocardial infarction * Permanent phrenic nerve paralysis * Pulmonary edema * Severe pericarditis * Significant pericardial effusion/tamponade * Stroke/cerebrovascular accident (CVA) * Systemic/pulmonary embolism requiring intervention * Transient ischemic attack (TIA) * Vagal nerve injury resulting in esophageal dysmotility or gastroparesis * Vascular access complications requiring intervention * Acute Kidney Injury (AKI) requiring dialysis, new hospitalization greater than 48 hours, or prolongation of hospitalization greater than 48 hours beyond the expected discharge * Death Within 3 months post-ablation: - Atrioesophageal fistula/Esophageal perforation (procedure and PulseSelect PFA Loop Catheter related) Within 6 months post-ablation: - Pulmonary vein stenosis (≥70% diameter reduction)
Effectiveness: Number of Participants with Treatment Success
Time frame: Up to 12 months post procedure
Treatment success is defined as freedom from documented recurrence of AF, AT, or AFL based on electrocardiographic data up to the 12-month follow-up and excluding a 90-day blanking period. Treatment failure is defined as any of the following components: * Acute procedural failure (see definition below) * Documented AF/AT/AFL after the 90-day post-ablation blanking period * Any subsequent AF catheter or surgical ablation in the LA, including repeat PVI ablation at any time during the study. * Direct current cardioversion for AF/AT/AFL recurrences after the 90-day blanking period. * Use of a Class I or III AAD at a higher daily dose than the pre-ablation maximum daily dose after the 90-day blanking period. * Initiation of a new Class I or III AAD after the 90-day blanking period. * Re-initiation after the 90-day blanking period of any dose of a Class I or III AAD that was failed or was not tolerated prior to the ablation 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 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Jason Andrade, Prof. principal investigator
Vancouver General Hospital
Gerhard Hindricks, Prof. principal investigator
German Heart Center Charite
Questions about this trial
What is this clinical trial studying?
A study testing PulseSelect Pulse Field Ablation (PFA) System in people with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions.
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 9 inclusion and 39 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Rob van der Straaten, PhD (+31611249276, rob.vanderstraaten@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of Participants with at Least One Primary Safety Event (time frame: Up to 6 months post procedure). 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 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.