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Cryptogenic Stroke clinical trials

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NCT ID: NCT05774288 Recruiting - Clinical trials for Patent Foramen Ovale

Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

Start date: June 8, 2023
Phase: N/A
Study type: Interventional

To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;

NCT ID: NCT05565781 Recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke

SMARTTHUNDER
Start date: March 28, 2022
Phase: N/A
Study type: Interventional

Stroke recurrence largely depends on the detection of the cause and the control of vascular risk factors, with occult atrial fibrillation (AF) being one of the most important. Prolonged ambulatory cardiac monitoring is recommended for detecting occult AF. Currently, there are non-invasive monitoring devices such as the textile Holter that have proven to be useful for monitoring for up to 30 days but not longer. Another alternative is smartwatches, although they must be validated for use in the elderly population who have had a stroke.

NCT ID: NCT05537753 Recruiting - Clinical trials for Patent Foramen Ovale

Encore PFO Closure Device - The PerFOrm Trial

Start date: July 12, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05529901 Recruiting - Stroke Clinical Trials

Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

GSO-PFO PMS
Start date: October 3, 2022
Phase:
Study type: Observational

The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.

NCT ID: NCT05486221 Recruiting - Atrial Fibrillation Clinical Trials

Atrial Imaging and Cardiac Rhythm In Embolic Stroke

ARIES
Start date: December 17, 2020
Phase:
Study type: Observational

The ARIES study is an observational study in which patients with a recent acute ischemic stroke of cryptogenic aetiology are consecutively enrolled in order to perform a extensive cardiologic work-up. The main objective is to study parameters that could predict arrythmias on prolonged monitoring and also echocardiographic parameters of left atrial disfunction that could predict the presence of a hidden atrial fibrilation and recurrent ischemic events in patients with cryptogenic stroke.

NCT ID: NCT05007847 Recruiting - Atrial Fibrillation Clinical Trials

Improving AF Detection in Cryptogenic Stroke

CSAF-AW
Start date: February 4, 2022
Phase: N/A
Study type: Interventional

No cause for stroke is found in up to 30% of cases despite extensive investigations. These are called cryptogenic strokes (CS). 1 in 4 stroke survivors will suffer another in 5 years and this is a leading cause of fear and anxiety. A common reason for CS is an undetected heart rhythm disorder called atrial fibrillation (AF). AF occurs intermittently, so it may not be detected during the mandated 24-96 hours of rhythm monitoring that is performed as part of the standard post-stroke investigation strategy. A randomised controlled study in 2014 showed that whereas this standard monitoring strategy picks up AF in 2% of CS patients, longer-term, continuous monitoring for 12 months can pick up AF in 13% of patients. This suggests the standard strategy may miss AF in a proportion of CS patients and thus also the opportunity to mitigate against further strokes with anticoagulation therapy. Prolonged monitoring has traditionally required a minimally-invasive surgical procedure to implant a recording device under the skin at a specialist centre. A specifically trained team is also required to interpret the large number of recordings this strategy yields. The Apple Watch (AW) is a wristwatch able to monitor a wearer's heart rate and rhythm regularity and facilitates real- time, single-lead ECG recordings. This over-the-counter, non-invasive device has demonstrated feasibility and has a Certification (CE) Mark for detecting AF. It may offer a potential non-invasive alternative long-term rhythm surveillance strategy to diagnose AF in these patients. The investigators propose a study in which CS patients will be randomised in a 1:1 ratio to receive additional AW monitoring on top of standard care versus standard care alone. The investigators shall then explore the incidence of AF in the two groups at 1 year and how it impacts clinical outcomes too.

NCT ID: NCT05006105 Recruiting - Atrial Fibrillation Clinical Trials

Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients

REMOTE
Start date: October 12, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the added value of mobile health (mHealth) to detect atrial fibrillation (AF) early in the care path of cryptogenic stroke and transient ischemic attack (TIA) patients.

NCT ID: NCT04881578 Recruiting - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study

ALFA ROMEO
Start date: March 31, 2021
Phase:
Study type: Observational

The aim of the ALFA ROMEO study is to better understand the association between cryptogenic stroke, PFO, PFO closure and AF.

NCT ID: NCT04285918 Recruiting - Cryptogenic Stroke Clinical Trials

Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale

DefenseElderly
Start date: October 2, 2019
Phase:
Study type: Observational

The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)

NCT ID: NCT04075084 Recruiting - Atrial Fibrillation Clinical Trials

Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

BIOSTREAM-ICM
Start date: October 28, 2019
Phase:
Study type: Observational [Patient Registry]

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. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.