Arrhythmias, Cardiac Clinical Trial
Official title:
EASe 2- an Epicardial Access Study With the EpiAccess System- A Post-market Follow up Study.
Prospective non-randomized, single arm trial to further evaluate the safety and performance of EpiAccess, the study device, for gaining access to the normal, non-distended pericardial space during epicardial diagnostic or therapeutic (ablation) procedures.
Prior to enrolment, patients will be evaluated on the basis of the latest available data to
establish eligibility. Eligible patients will be enrolled in the study by the local
principal investigator after informed consent is obtained.
As EpiAccess is only used for the access portion of electrophysiology procedures, the
safety, performance and effectiveness endpoints are acute from the time of needle insertion
to pericardial space access (guidewire insertion into the pericardial sac). Patients will be
followed until hospital discharge. Follow-up clinical examinations will be performed in
accordance with institutions' standard of care. No special tests are required for this
device. Patients' completion of study will occur at the time of their hospital discharge, or
earlier if patient did not complete the study.
The stop criterion for this study is: greater than 25% Serious Adverse Device Effect, as
defined in this protocol, after enrolment of 10 or more patients, compared to existing data
from the literature presenting epicardial access procedure results during sub-xyphoid
(minimally invasive) surgical procedures.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03079726 -
Use of Device Data to Predict Frailty in Individuals
|
||
| Recruiting |
NCT06014996 -
Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.
|
N/A | |
| Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
| Completed |
NCT05404789 -
Tolerance of Centrifuge-induced Acceleration in Subjects With Diabetes Mellitus and Cardiac Arrhythmia
|
N/A | |
| Recruiting |
NCT04554160 -
Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
|
||
| Recruiting |
NCT04471584 -
Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors
|
N/A | |
| Recruiting |
NCT02906189 -
Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
|
N/A | |
| Completed |
NCT02466633 -
Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias
|
N/A | |
| Completed |
NCT02550340 -
Munich Study for Beer Related ECG Change Workup
|
N/A | |
| Completed |
NCT01871090 -
Remote Device Interrogation In The Emergency Department
|
N/A | |
| Completed |
NCT04884100 -
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening
|
N/A | |
| Withdrawn |
NCT04556240 -
RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
|
||
| Active, not recruiting |
NCT05481359 -
AF-FLOW Registry: This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation.
|
||
| Recruiting |
NCT05047835 -
Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients
|
||
| Not yet recruiting |
NCT05957315 -
Mobile Cardiac Outpatient Telemetry for Unexplained Syncope
|
N/A | |
| Not yet recruiting |
NCT05974306 -
Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System
|
N/A | |
| Completed |
NCT06260670 -
FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation
|
N/A | |
| Active, not recruiting |
NCT04876963 -
HOLT-ED: Holter-monitoring in End-stage Renal Disease
|
||
| Completed |
NCT04943354 -
Associations of Combinations of Single-nucleotide Polymorphisms in Women With Premature Ovarian Failure
|
N/A | |
| Recruiting |
NCT03857711 -
Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
|
N/A |