Clinical Research Directory

Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

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.

Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study

The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a stroke that may be related to this heart opening. The main question it aims to answer is: • Is the P3 Occluder System safe and effective for closing a PFO in patients who have had a stroke that could be related to a PFO. Participants will: * Undergo the procedure to implant the P3 Occluder System, if deemed appropriate. * Visit their doctor at 1 month, 3 months, 6 months, 1 year, and 5 years after the procedure for follow up exams. * Answer a phone call from study staff at 2 years, 3 years, and 4 years after the procedure to answer a survey.

Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

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.

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. 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.

Stroke of Unknown Cause in Women: The Impact of Long-term Heart Monitoring on Stroke Recurrence

The goal of this observational study is to investigate sex - differences in detection rate of atrial fibrillation after cryptogenic stroke (embolic stroke of unknown cause) - using an implantable cardiac rhythm monitor - and the treatment effects of oral anticoagulation on recurrent stroke, ischemic cardiovascular events, major bleeding risk, disability and mortality. The main questions to answer are: * Is long-term monitoring and detection of atrial fibrillation after stroke of unknown cause in women related to recurrent stroke and disability? * Is long-term monitoring and initiation of oral anticoagulation related to cardiovascular events and intracranial haemorrhages? And in addition increased in women compared to men? * Is long-term rhythm monitoring after stroke with unknown cause related to patient reported outcomes in women?

Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study

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

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

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.

Cardiac Abnormalities in Stroke Prevention and Risk of Recurrence

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.

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.

Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke

Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients. The use of implantable cardiac monitors (ICM) early after the CS has demonstrated benefits in the diagnostic yield, but the indication for ICM in the current guidelines remains unclear. Atrial contraction strain (ACS) evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF. The purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS. Clinical and ultrasound predictors of PAF occurrence (ACS) will be studied in order to define patients needing a closer follow-up.

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

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.

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;