Paroxysmal Atrial Fibrillation
Conditions
Brief summary
The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical data from the literature.
Interventions
DEVICECerebral Diffusion-Weighted Magnetic Resonance Imaging
Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI)
DEVICETransesophageal Echocardiography
Patients undergo a Transesophageal Echocardiography prior to the ablation itself
OTHERPaperbased neurocognitive testing
To assess the impact of PVI on the patient's neurocognitive status
Sponsors
University Hospital Heidelberg
Biotronik SE & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Electrocardiographically documented, symptomatic paroxysmal AF. * Patients with indication for left atrial ablation of AF according to ESC guidelines for the management of atrial fibrillation. * Anticoagulation according to clinical routine using coumarin derivates with target INR between 2.0 and 3.0 at least 3 weeks prior to the scheduled ablation procedure or novel oral anticoagulants (NOACs). * Geographically stable for the duration of the study. * Willingness and ability to perform written informed consent
Exclusion criteria
* Long standing persistent or persistent AF * CHA2DS2-VASc score ≥ 5 * Prior ischemic stroke or Transient Ischemic Attack * Previous Pulmonary Vein ablation * Contraindication for anticoagulation therapy * Contraindication for Diffusion-Weighted MRI * Claustrophobia * Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE, if TEE not possible) * Implanted cardiovascular device, including but not limited to an atrial or ventricular pacemaker or defibrillator leads, artificial valves, stents, septal or LAA occluders * Acute coronary syndrome \< 3 months prior to scheduled ablation * Moderate to severe valvular heart disease * LA size \> 55 mm (confirming echo at maximum 3 months old) * Patients with non-controlled heart failure or patients with current and recent (\< 1 month prior to ablation) heart failure * Ejection fraction \< 35% (confirming echo at maximum 3 months old) * Conditions that prevent patient's participation in neurocognitive assessment (at physician's discretion) * Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study * Any limitation to contractual capability * Simultaneous participation in another study * Age \< 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thromboembolic lesions | 1-3 days | The occurrence of one or more new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation assessed by Diffusion-Weighted MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive status | Baseline, 1-3 days and 3 months | To assess the impact of PVI on the patient's neurocognitive status measured by a testing battery including the STATE questionnaire, d2 test of attention, visual part of the visual and verbal memory test (VVM2) and Montreal Cognitive Assessment (MOCA) subtest |
| Peri-procedural serious adverse events | Within 24 hours after ablation | Any serious adverse event occurring during the ablation procedure and within 24 hours from completion of the procedure |
| Post-procedural clinical TE events | 3 months period | Composite endpoint: Occurrence of Transient Ischemic Attack and/or Ischemic Stroke and/or Systemic Embolism during the three months post-ablation period (excluding peri-procedural events) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acute procedural success rate | During ablation | Acute procedural success of Pulmonary Vein Isolation, defined as electrical isolation of all Pulmonary Veins (entrance block) |
| Success of Pulmonary Vein Isolation | 3 months | Three months ablation success, defined as freedom from symptomatic AF recurrences off antiarrhythmic drug therapy assessed to three-month follow-up |
Countries
Czechia, Germany, Hungary, Netherlands, Switzerland
Outcome results
None listed