Single-Shot Versus Focal Dual-Energy Pulsed Field-Based Ablation for Atrial Fibrillation

NCT07783919 | Not Yet Recruiting

• 1 other identifier: DUAL-AF-2026-01
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of single-shot PFA systems with focal dual-energy (PFA/RF) in patients at high risk of atrial fibrillation recurrence.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial arrhythmias during follow-up

  Rate of participants with freedom from atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia) during follow-up, excluding the blanking period

  365 days, excluding the blanking period

Secondary Outcomes (7)

• Freedom from atrial fibrillation/atrial tachycardia

  365 days, excluding the blanking period

• First-pass isolation rate and acute PVI success

  Day of the ablation (periprocedural)

• Procedural durations

  Day of the procedure (periprocedural)

• Correlation between procedural parameters and clinical efficacy

  365 days, excluding the blanking period

• Electroanatomical evaluation in the event of potential re-ablation

  day of the potential re-ablation (periprocedural)

Study Arms (2)

Single shot PFA-based Ablation for AF

ACTIVE COMPARATOR

Procedure: Catheter Ablation for Atrial Fibrillation

Focal Dual-Energy-based Ablation for Atrial Fibrillation

PLACEBO COMPARATOR

Procedure: Catheter Ablation for Atrial Fibrillation

Interventions

Catheter Ablation for Atrial Fibrillation PROCEDURE

PFA-based Catheter Ablation for Atrial Fibrillation (PFA single shot vs. focal dual-eregy)

Focal Dual-Energy-based Ablation for Atrial Fibrillation; Single shot PFA-based Ablation for AF

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• First-time pulmonary vein isolation
• Symptomatic atrial fibrillation:
• Paroxysmal atrial fibrillation (≥ 2 episodes in the last 6 months) and one of the following:
• CHA2DS2VA score ≥ 2, ≥ 1 cardioversion in the last 6 months or Left atrial (LA) diameter ≥ 45 mm
• o or persistent atrial fibrillation (≥ 1 episode in the last 6 months)

You may not qualify if:

• Atrial fibrillation due to reversible or non-cardiac causes
• Severe mitral or tricuspid valve regurgitation requiring therapy
• Previous left atrial endocardial or epicardial ablation
• Pregnancy or breastfeeding
• Lack of opportunity for reliable study participation

Sponsors & Collaborators

• Marien Hospital Herne: lead

Study Sites (1)

Marien Hospital Herne

Herne, North Rhine-Westphalia, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Dimitrios Bismpos, Dr.med.

CONTACT

+49023234995609; Dimitrios.Bismpos@elisabethgruppe.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Dimitrios Bismpos

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 25, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

DE (1)