RecruitingNot ApplicableNCT05294445
From the Emergency Department Directly to Ablation of Atrial Fibrillation Study
From the Emergency Department Directly to Ablation of Atrial Fibrillation - Study - The "EMERGE-Cryo-Study"
Sponsor
Asklepios proresearch
Enrollment
350 participants
Start Date
Dec 15, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
The study is a prospective, two-arm, randomized, open-label, blinded endpoint, multi-center study to investigate the impact of first line ablation in patients presenting at the emergency room with recent-onset paroxysmal or persistent atrial fibrillation.
Eligibility
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria5
- Documented, paroxysmal or persistent AF (longest AF episode \< 6-month duration). Any ECG documentation of AF (12 lead ECG, Holter ECG or mobile ECG monitoring) needs to be presented.
- Recent-onset AF (≤ 1 year prior to enrolment)
- Presenting at the emergency department or outpatient clinic within the last 2 weeks because of AF, including patients with spontaneous conversion in sinus rhythm (with prior AF documentation)
- Age ≥ 18 years
- Subject is able and willing to give informed consent
Exclusion Criteria15
- Pers. AF \> 6 Mon (one episode)
- LA-Diameter \> 60mm
- Severe mitral stenosis or regurgitation, prior mitral valve reconstruction or replacement
- Any previous left atrial ablation
- Ongoing continuous AAD therapy with Amiodarone at baseline
- History of failed continuous AAD therapy with \> 1 agent. Exceptions are Beta blocker, Verapamil or "pill in the pocket"-therapy.
- Any condition or disease, which is contraindication for AF ablation, up to the assessment of the investigator
- Any condition or disease, which is a contraindication for antiarrhythmic drug treatment, up to the assessment of the investigator
- Known intra-cardiac thrombus formation under continuous oral anticoagulation (defined as intake \>4 weeks)
- Any contraindication for oral anticoagulation
- Any untreated or uncontrolled hyperthyroidism or other reversible causes for AF like alcoholism
- Pregnant or breastfeeding woman or woman of childbearing potential not on adequate birth control
- Active systemic infection
- Co-Existence of non PV-dependent atrial Tachycardia
- Indication for implantation of ICD or pacemaker
Interventions
PROCEDUREAblation of atrial fibrillation (AF)
Cryo-AF-ablation of pulmonary vein (pulmonary vein isolation = PVI)
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05294445
Related Trials
Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
NCT0678446626 locations
COCONUT Study Concomitant PVI and LAAC
NCT068616731 location
LA Function After PFA in Paroxysmal AF
NCT074390161 location
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
NCT0717542837 locations
Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters
NCT071307731 location