Safety and Efficacy of New, Non-thermal Ablation Techniques for the Treatment of Atrial Fibrillation - A Comparison of Two Ablation Systems
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alfried Krupp Krankenhaus
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Primary outcome: Freedom from arrhythmia
Study Overview
Brief Summary
Two non-thermal ablation techniques approved for routine clinical practice (CE-marked) for the interventional treatment of atrial fibrillation are compared in a 1:1 randomization to investigate patient data, procedural data, effectiveness, and safety.
Detailed Description
Patients with paroxysmal atrial fibrillation were randomized 1:1 to undergo pulmonary vein isolation using pulsed field ablation (PFA) with either single-shot PFA (FARAPULSE) or single-tip PFA (Galvanize Therapeutics). Baseline characteristics, procedural data, effectiveness, and safety outcomes were analyzed. In each group, a subset of consecutive patients underwent cerebral magnetic resonance imaging to assess silent cerebral lesions and was scheduled for biomarker assessment (blood sampling) to evaluate inflammation and troponin release after PFA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Recurrent, symptomatic paroxysmal atrial fibrillation
- •Age > 18 years
- •Patient consen
Exclusion Criteria
- •Refusal of the patient
- •Inability to provide informed consent
- •Life expectancy < 2 years
- •Pregnancy and breastfeeding (due to radiation exposure)
- •History of left atrial ablation
- •Known macro-reentry or focal atrial tachycardia
- •Significant mitral valve stenosis
- •History of heart valve replacement or reconstruction
- •NYHA class III and IV
- •Left ventricular ejection fraction < 35%
- •Left atrial enlargement > 55 mm on echocardiography
- •Intracardiac thrombus prior to the procedure
- •Severe pulmonary disease with abnormal blood gases or requiring oxygen therapy
- •Renal insufficiency (GFR < 30 mL/min) due to contrast medium use
- •Stroke or TIA within the last 6 months
- •Symptomatic carotid stenosis
- •Active malignancy within the previous 24 months
- •Untreated or uncontrolled thyroid disease
- •Active bleeding or chronic bleeding tendency not amenable to curative treatment
- •Body mass index > 35 kg/m²
- •Contraindication to CT examination (e.g., contrast medium allergy or severe claustrophobia)
Arms & Interventions
Single-Shot Pulsed Field Ablation
Single-Shot Pulsed Field Ablation is performed using the FARAPULSE PFA System
Intervention: Pulmonary vein isolation (Device)
Single-Shot Pulsed Field Ablation
Single-Shot Pulsed Field Ablation is performed using the FARAPULSE PFA System
Intervention: cerebral magnetic resonance tomography (Radiation)
Single-Shot Pulsed Field Ablation
Single-Shot Pulsed Field Ablation is performed using the FARAPULSE PFA System
Intervention: Biomarker assessment (C-reacitve Protein, troponine) (Diagnostic Test)
Single-Tip Pulsed Field Ablation
Single-Tip Pulsed Field Ablation is performed using a conventional ablation catheter in combination with a pulsed field ablation generator.
Intervention: Pulmonary vein isolation (Device)
Single-Tip Pulsed Field Ablation
Single-Tip Pulsed Field Ablation is performed using a conventional ablation catheter in combination with a pulsed field ablation generator.
Intervention: cerebral magnetic resonance tomography (Radiation)
Single-Tip Pulsed Field Ablation
Single-Tip Pulsed Field Ablation is performed using a conventional ablation catheter in combination with a pulsed field ablation generator.
Intervention: Biomarker assessment (C-reacitve Protein, troponine) (Diagnostic Test)
Outcomes
Primary Outcomes
Primary outcome: Freedom from arrhythmia
Time Frame: 12 months follow-up
The clinical efficacy, e.g. freedom from atrial arrhythmias / atrial fibrillation is assessed by 5-7 day Holter Monitoring at 3, 6 and 12 months after the procedure. Any documented arrhythmia episode lasting \>30s was calculated as failure. A three months blanking period was considered.
Secondary Outcomes
- Secondary outcomes: Complications, Silent cerebral lesions (cMRI) and biomarker assessments(6 weeks)
Investigators
Kars Neven
MD, PhD.
Alfried Krupp Krankenhaus