Reduction of AF ablation Induced Thrombo-Embolic Incidence Pilot Study
- Conditions
- Arrhythmiaatrial fibrillation10007521
- Registration Number
- NL-OMON43627
- Lead Sponsor
- Biotronik SE & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
* sympotomatic paroxysmal atrial fibrillation (AF)
* indication for left atrial ablation for AF according to ESC guidelines
* Anticoagulation according to clinical routine using coumarin derivates with a target INR between 2.0 and 3.0 for at least 3 weeks prior to the scheduled ablation procedure or novel oral anticoagulants (NOACs).
* geographically stable during the study
* patient is willing and able to provide written informed consent
* < 18 years
* Long standing persistent or persistent Atrial Fibrillation
* CHA2DS2-VASc score >= 5
* Prior ischemic stroke or Transient Ischemic Attack
* Previous PV ablation
* Contraindication for antigoagulation therapy
* Contraindication for Diffusion-Weighted MRI
* Claustrophobia
* Contraindication for transesophageal echocardiography (TEE) or intracardiac echography (ICE, if TEE not possible)
* Implanted cardiovascular device
* Acute coronary syndrome < 3 months prior to scheduled ablation
* Moderate to severe valvular heart disease
* LA size > 55 mm
* non-controlled heart failure or current and recent heart failure (< 1 month prior to ablation)
* Ejection fraction < 35%
* Conditions that prevent patient*s participation in neurocognitive assessment
* Female patients who are pregnant or breast feeding
* footnote: ferromagnetic implants without approval for MRI investigations at the respective MRI unit.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The occurrence of one or more new subclinical cerebral TE lesions after PVI<br /><br>assessed by Diffusion-Weighted MRI.</p><br>
- Secondary Outcome Measures
Name Time Method