From the Emergency Department Directly to Ablation of Atrial Fibrillation - Study - The EMERGE-Cryo-Study

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Kerckhoff-Klinik GmbH
RECRUITING
Bad Nauheim
Deutsches Herzzentrum der Charité
RECRUITING
Berlin
Herzzentrum Uniklinik Köln
RECRUITING
Cologne
Evangelisches Krankenhaus Düsseldorf
ACTIVE_NOT_RECRUITING
Düsseldorf
Cardioangiologisches Zentrum Bethanien (CCB) am Markuskrankenhaus
RECRUITING
Frankfurt
Universitätsklinikum Giessen
RECRUITING
Giessen
AK Altona
RECRUITING
Hamburg
Asklepios Klinik St. Georg
RECRUITING
Hamburg
Universitäres Herz- und Gefäßzentrum
RECRUITING
Hamburg
AK Nord
ACTIVE_NOT_RECRUITING
Hamburg-nord
Asklepios Klinik Harburg
RECRUITING
Harburg
Universitätsklinikum Münster
RECRUITING
Münster
St. Josefs-Hospital Wiesbaden GmbH
RECRUITING
Wiesbaden
Contact Information
Primary
Nele Gessler, MD, PhD
n.gessler@asklepios.com
+49-40-181885-3069
Backup
Kathrin Heitmann
ka.heitmann@asklepios.com
+49-40-181885-5406
Time Frame
Start Date: 2021-12-15
Estimated Completion Date: 2028-12-14
Participants
Target number of participants: 350
Treatments
Active_comparator: Group1: Cryo-AF-Ablation
Patients randomized in the Cryo-AF-Ablation group should receive the cryo AF ablation within 21 days from baseline.
No_intervention: Group 2: Usual care
Patients randomized in the usual care group should start or maintain on AAD therapy within 21 days from baseline, based on decision of the investigator according to current ESC Guidelines.
Related Therapeutic Areas
Sponsors
Collaborators: Medtronic Bakken Research, Atrial Fibrillation Network
Leads: Asklepios proresearch

This content was sourced from clinicaltrials.gov