Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation

NCT07575828 | Not Yet Recruiting

• 1 other identifier: MDT25021
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Paroxysmal Atrial Fibrillation (PAF); Persistent Atrial Fibrillation

Keywords

Atrial Fibrillation (AF); Paroxysmal AF; Persistent AF; Symptomatic recurrent AF; Arrhythmia; PulseSelect PFA System; Pulsed Field Ablation; Catheter ablation; Pulmonary Vein Ablation

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Up to 12 months post procedure

Study Arms (1)

AF ablation

EXPERIMENTAL

AF Ablation using the PulseSelect Pulse Field Ablation (PFA) System

Device: PulseSelect Pulse Field Ablation (PFA) System

Interventions

PulseSelect Pulse Field Ablation (PFA) System DEVICE

Adult subjects with recurrent symptomatic paroxysmal AF or persistent AF will be enrolled and undergo ablation with the PulseSelect™ PFA system.

AF ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Rob van der Straaten, PhD

CONTACT

+31611249276; rob.vanderstraaten@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share