Clinical trials: Cryptogenic Stroke
Foramen Ovale, Patent
The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
The primary objective of this study is to demonstrate the safety and efficacy of the PFX Closure System when utilized for patent foramen ovale (PFO) in patients suffering from cryptogenic stroke (undetermined cause of stroke)…
- Trial name
- NCT00196040
- Testing
- PFX Closure System
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Cierra
Patent Foramen Ovale, Cryptogenic Stroke
Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
- Trial name
- NCT05774288
- Testing
- Cera™ patent foramen ovale occluders, Another patent foramen ovale occluders
- Where
- 14 sites in China
- Volunteers
- 244 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Suspected Arrhythmia, Palpitations
This Exploratory Medical Device Study Evaluated the Arrhythmia Diagnostic Yield of MEMO Patch V2, a Wearable Patch-type Electrocardiographic Monitor, in Adults With Suspected Arrhythmia Who Presented With Symptoms Such as Palpitations or Dizziness, or Who Had Cryptogenic Ischemic Stroke or Transient
This exploratory medical device study evaluated the arrhythmia diagnostic yield of MEMO Patch V2, a wearable patch-type electrocardiographic monitor, in adults with suspected arrhythmia who presented with symptoms such as…
- Conditions
- Suspected Arrhythmia, Palpitations, Dizziness, Cryptogenic Ischemic Stroke
- Trial name
- NCT07722026
- Testing
- MEMO Patch V2, 24-Hour Holter Monitor
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- HUINNO Co., Ltd
Patent Foramen Ovale, Stroke
Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)
The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO…
- Conditions
- Patent Foramen Ovale, Stroke, Ischemic Attack, Transient
- Trial name
- NCT00201461
- Testing
- STARFlex septal closure system, Best medical therapy
- Where
- United States
- Volunteers
- 900 people
- Sponsor
- NMT Medical
Stroke, PFO - Patent Foramen Ovale
The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO
Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.
- Trial name
- PROOF (NCT04029233)
- Testing
- Occlutech PFO Occluder
- Where
- 17 sites in Canada, France and 2 more
- Volunteers
- 582 people
- Sponsor
- Occlutech International AB
Patent Foramen Ovale, Stroke
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
This study is a prospective, multicenter, randomized, controlled, single-blind, investigator-driven, non-profit clinical trial designed to compare the safety and efficacy of the Cocoon PFO Occluder with the Amplatzer PFO Occluder…
- Conditions
- Patent Foramen Ovale, Stroke, Transient Ischemic Attack (TIA)
- Trial name
- SAFE-PFO (NCT07380490)
- Testing
- PFO Closure procedure
- Where
- Germany
- Volunteers
- 1,260 people
- Sponsor
- Giuseppe Tarantini
Patent Foramen Ovale, Cryptogenic Stroke
Encore PFO Closure Device - The PerFOrm Trial
The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.
- Trial name
- NCT05537753
- Testing
- Encore PFO closure device, FDA-approved PFO closure device
- Where
- 8 sites in United States
- Volunteers
- 500 people
- Sponsor
- Encore Medical Inc.
Syncope, Cryptogenic Stroke
BIO|STREAM.ICM France
The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system
- Trial name
- NCT04206774
- Where
- 3 sites in France
- Volunteers
- 92 people
- Sponsor
- Biotronik SE & Co. KG
Tachycardia Atrial, Atrial Fibrillation
BIO|STREAM.ICM Obesity
The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.
- Conditions
- Tachycardia Atrial, Atrial Fibrillation, Syncope, Bradycardia
- Trial name
- NCT04198220
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Biotronik SE & Co. KG
Tachycardia, Atrial Fibrillation
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up.
- Conditions
- Tachycardia, Atrial Fibrillation, Syncope, Bradycardia
- Trial name
- BIOSTREAM-ICM (NCT04075084)
- Where
- 31 sites in Australia, Czechia and 7 more
- Volunteers
- 1,400 people
- Sponsor
- Biotronik SE & Co. KG
Stroke, Transient Ischemic Attack
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk…
- Trial name
- REDUCE (NCT00738894)
- Testing
- Septal Occluder Device, Antiplatelet Medical Therapy
- Where
- 2 sites in United States, Denmark
- Volunteers
- 664 people
- Sponsor
- W.L.Gore & Associates
Cryptogenic Stroke
Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent…
- Trial name
- NCT00465270
- Testing
- AMPLATZER PFO Occluder, Standard of Care - Medical Management
- Where
- 69 sites in United States, Canada
- Volunteers
- 980 people
- Sponsor
- Abbott Medical Devices