Atrial and ventricular arrhythmia I48 I49
Conditions
Interventions
Group 1: The study population consists of patients with electrocardiogram documented atrial fibrillation or atrial flutter.
For the investigation, the TeslaSX1 will be used as part of a planned medic
Sponsors
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patient has electrocardiogram (ECG) documented atrial fibrillation or atrial flutter, and there is clinical indication for a synchronized electrical cardioversion. • Patient has no Sick Sinus Syndrome (SSS) • Patient is hemodynamic stable (Syst Bp > 100mmHg) • Patient has a body mass index (BMI) = 40. • Patient has been adequately informed of risks and requirements of the trial and written informed consent is provided • Patient has none of the described contraindications. • MRI informed consent has been obtained and all inclusion and exclusion criteria required therein have been met. • Patient has no active implantable devices (Pacemaker, ICD, etc.) to avoid interaction with the magnetic field of the MRI. • Patient has no known allergy or hypersensitivity to device materials. • Patients who have been in AF >48h is under therapeutic anticoagulation the preceding 3 weeks or shows a negative transoesophageal echocardiography (TOE) result (to rule out a left atrial thrombus before cardioversion). • Patient is not under arrest (in the sense of MPDG §27). • Patient has no documented alcohol or drug abuse. • Patient is not pregnant, breastfeeding or patient did not give birth within the last 30 days. • Patient is not an employee of the investigator or investigation site, with direct involvement in this investigation or other trials under the direction of the investigator or investigation site, as well as family members or employees of the investigators. • Patient was not participating in any other trial involving investigational drugs or devices within 4 weeks prior to screening and patient must agree not to participate in any other clinical trial at the same time and not for a period of 1 month after the cardioversion procedure.
Exclusion criteria
Exclusion criteria: • Patient is unwilling or unable to comply with trial requirements. • Patients who met all inclusion criteria but had changes that affected at least one inclusion criterion before the procedure was performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device effectiveness endpoint: By performing a successful cardioversion, the device is considered to have functioned as intended. ECG evidence of at least one sinus heartbeat directly following the application of a synchronized shock delivery is considered as the definition of a successful cardioversion. According to the standard protocol for cardioversion, up to three consecutive attempts (shocks) are allowed. Only if all 3 shocks fail to restore sinus rhythm, cardioversion is considered as unsuccessful. | — |
Countries
Germany
Contacts
Public ContactStefan Ulbrich
Herzzentrum Dresden GmbH, Universitätsklinik an der Technischen Universität Dresden, Klinik für Innere Medizin und Kardiologie
Outcome results
None listed