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Cryptogenic Stroke clinical trials

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NCT ID: NCT06398366 Enrolling by invitation - Cryptogenic Stroke Clinical Trials

Cardiac Abnormalities in Stroke Prevention and Risk of Recurrence

CASPR
Start date: September 14, 2022
Phase:
Study type: Observational

This is a multi-center retrospective analysis of consecutive adult patients with cryptogenic stroke patients following a comprehensive workup for the underlying stroke etiology. Patients will be eligible for inclusion if the index stroke event occurred between 1/1/2016 and 06/30/2022.

NCT ID: NCT05907694 Active, not recruiting - Clinical trials for Patent Foramen Ovale

Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

STOP
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.

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: NCT05312554 Withdrawn - Clinical trials for Patent Foramen Ovale

Safety and Efficacy of IrisFIT™ Patent Foramen Ovale Occluders

Start date: April 12, 2022
Phase: N/A
Study type: Interventional

To evaluate the performance of patent foramen ovale (PFO) device developed by Lifetech Technology (Shenzhen) Co., LTD

NCT ID: NCT05213104 Active, not recruiting - Clinical trials for Patent Foramen Ovale

Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia

AFLOAT
Start date: March 23, 2022
Phase: Phase 3
Study type: Interventional

About 30% of ischemic strokes are cryptogenic. Patent Foramen Ovale (PFO) is present in about 25% of the general population. In cryptogenic strokes, PFO has been shown to be overrepresented and recent intervention studies have confirmed that PFO has a causal link with stroke. In patients with recent cryptogenic stroke, these randomized studies have shown at least 50%-reduction of recurrent neurological events after PFO percutaneous closure compared with medical therapy alone. At the The risk of AF reported in these studies in certainly largely underestimated as only symptomatic and recorded episodes of AF have been declared. Patients often report palpitations without a dia gnosis of AF made on the ECG or a Holter. Long term ECG monitoring provides more accurate data on AF incidence. Administration of flecainide has been shown to be effective in preventing Atrial arrhythmia and may be useful in preventing these Atrial arrhythmia(AA) episodes after PFO closure. To the knowledge of the investigators, there is no study assessing the efficacy of any antiarrhythmic drug in the prevention of AFafter PFO closure. AFLOAT will be the first randomized study to possibly validate flecainide to prevent Atrial arrhythmia in these patients.

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.