Atrial Fibrillation Clinical Trial
Official title:
A Phase III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
There are approximately 2 million reported prevalent cases of atrial fibrillation (AF) and
atrial flutter in the United States (Heart Disease & Stroke Statistics - 2003 Update, AHA).
These arrhythmias may be occasional or sustained. While not directly fatal, these
arrhythmias cause discomfort and can lead to stroke or congestive heart failure.
This Phase III trial is Cardiome's first pivotal study with RSD1235. The study seeks to
confirm the findings of the Phase II proof-of-concept through demonstration of RSD1235's
abilities to convert AF to sinus rhythm. The patient population will include recent onset AF
(AF duration of 3 hours to 7 days) and patients with longer AF duration.
This is a double-blind, placebo-controlled, randomized study in patients with AF;
stratification will be based on duration of AF. Treatment will be considered successful if
there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum
of 1-minute by Hour 1.5 (Time 0 = start of first infusion). All patients will be evaluated
for safety.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
| Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
| Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
| Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
| Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
| Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
| Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
| Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
| Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
| Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
| Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
| Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
| Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
| Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
| Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
| Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
| Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
| Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
| Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |