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NCT03309332
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
NCT07172464
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.
NCT05069558
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE).
NCT07420400
This study will test the sensitivity of a novel, battery-powered, non-invasive ultrasound device to detect a right-to-left shunt
NCT06590467
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017/745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.
NCT07374146
This project aims to address the need for individualized precision therapy for hemodynamically significant patent ductus arteriosus (hsPDA) in extremely preterm infants by integrating clinical biomarker screening with the design of a targeted drug-delivery system, and advancing early prediction and targeted intervention in a stepwise manner. Infants born at \<32 weeks' gestational age will be enrolled. Multi-time-point blood samples and relevant clinical parameters will be systematically collected, with a focus on measuring cardiac function biomarkers (NT-proBNP), inflammatory cytokines (IL-6), angiogenic factors (VEGF), and hematologic indices (PCT and PLR). A multi-marker combined predictive model will be developed to improve the identification of high-risk infants. Building on this foundation, a nano-delivery system will be constructed via self-assembly of ibuprofen molecules and targeting ligands to achieve localized, precise, and controlled release at the ductus arteriosus. Its therapeutic efficacy and safety will be evaluated through in-vitro release testing, cytotoxicity assays, and animal model experiments.
NCT07170176
Patent Foramen Ovale (PFO) is a common congenital heart defect. Recent studies have suggested a potential association between PFO and migraines, particularly migraine with aura. It is hypothesized that PFO may allow microemboli or vasoactive substances from venous blood to bypass pulmonary metabolism and enter the arterial system directly, potentially triggering migraines. Although PFO closure has been shown to reduce the frequency and severity of migraine attacks, its long-term efficacy and underlying mechanisms require further investigation. This study aims to explore the characteristics of glymphatic system function in PFO patients and its relationship with migraine symptoms, as well as the impact of PFO closure on glymphatic function and its role in alleviating migraine symptoms. A case-control and self-controlled before-after study design is adopted. Two groups of participants are enrolled: a case group consisting of PFO patients with significant right-to-left shunt and migraine, and a control group comprising PFO patients with significant shunt but without migraine. According to clinical guidelines and after obtaining informed consent, eligible patients in the case group undergo percutaneous PFO closure. By comparing migraine symptoms and glymphatic function indicators both before and after the procedure between the two groups, the interventional effect of PFO closure and its potential mechanism will be investigated. The primary endpoint is the improvement in migraine symptoms, while the secondary endpoints include glymphatic function metrics. The findings of this study will provide new theoretical insights and clinical guidance for the management of PFO-related migraines.
NCT06203873
Migraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults. Mechanisms linking PFO to migraine include cortical spreading depression, vascular active substance theory, impaired cerebral autoregulation, and genetic susceptibility. Understanding these mechanisms holds promise for overcoming challenges in the prevention and treatment of migraines in PFO patients. At least 11 observational studies, comprising 1,632 subjects, described the efficacy of PFO closure in cryptogenic stroke. Of these, 34% had migraines, and percutaneous PFO closure reportedly reduced migraine days by 81% (with a reduction of over 50% in monthly migraine days). Prospective randomized controlled trials (PRIMA and PREMIUM trials) assessing the Amplatzer® PFO Occluder showed significant benefits in most secondary endpoints, with a pooled analysis indicating its safety and effectiveness compared to medical therapy.While traditional metal PFO closure studies suggest symptom relief, reports also mention potential new-onset or worsened migraines post-closure. Proposed mechanisms include platelet activation, microthrombus formation, nickel allergy, and septal deformation or stretching inducing the release of migraine-related vascular active substances. However, these theories are closely tied to the presence of permanent metal implants. Addressing these concerns, the MemoSorb® biodegradable PFO Occluder system, approved by the National Medical Products Administration (NMPA) in September 2023, offers an innovative solution. Developed collaboratively by the National Biomedical Materials Engineering Technology Research Center, Professor Wang Yunbing\'s team, Professor Pan Xiangbin\'s team from Fuwai Hospital, Chinese Academy of Medical Sciences, and HeartTech Medical, this groundbreaking technology represents a shift from metal to degradable materials. The occluder serves as a temporary bridge post-implantation, gradually degrading with endothelialization, facilitating comprehensive self-repair. This intervention concept theoretically avoids the lifelong complications associated with traditional metal occluders, effectively reducing postoperative symptoms like migraines and dizziness. To assess and compare the treatment outcomes, especially in relieving migraines, a prospective, single-blind, randomized controlled study has been designed for patients with patent foramen ovale and migraine, comparing the novel biodegradable occluder with the metal occluder.
NCT05529901
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.
NCT06347276
This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO.
NCT07009678
Study Title LOwer vs upper extremity injection agitated saline for identifiCation of pATent foramen ovalE (LOCATE) Pilot study to determine safety of lower extremity injection of agitated saline for echocardiography of the heart. Primary Investigator Carmelo Panetta, MD University of Minnesota Physicians, St. John's Hospital 1600 St. Johns Blvd, suite 200, Maplewood, MN 55109 Study Design Prospective study of the safety and efficacy upper versus lower extremity injection agitated saline (bubble study) to identify patent foramen ovale (PFO) with echocardiography Study Objective PFO are not identified in up to one quarter of subjects who have upper arm injection compared to femoral vein injection. We propose use of the PICC line nurses to obtain access in the greater saphenous vein in the lower leg and compare to the upper extremity injection in those subjects with concern for paradoxical embolus but previously PFO was not identified with an upper arm injection. Study Endpoint Study the safety and efficacy of lower versus upper extremity injection agitated saline (bubble study) for identifying PFO Subject Population Subjects with history of cryptogenic stroke or arterial embolus of unknown source with negative upper extremity injection agitate saline (bubble study) to identify a PFO. Number of Sites Three sites to enroll subjects: St. John's/Woodwinds Hospital, University of Minnesota Medical Center and Southdale Hospital. One site to perform procedure at St John's hospital Expected Time to Complete Enrollment 8-12 months Schedule of Events Screening and consent of subjects who with negative bubble study for PFO to have upper and lower extremity bubble study, one week follow up and review echocardiography by two cardiologists. Additional Information Data safety monitoring board will oversee the results every quarter Sample size 20 subjects were consented and enrolled is supported by this grant from GORE Medical.
NCT05547165
Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.
NCT04713683
Percutaneous PFO closure has been established as a first-line therapy for preventing recurrent strokes in selected patients. The devices used for the specific purpose contain and release nickel, which is considered as the most allergen metal in nature. Skin patch tests are considered as gold-standard for documenting nickel allergy. While the allergic contact dermatitis induced by nickel is well described, literature is inadequate on explaining the effect of nickel release on the clinical manifestations of patients implanted with such devices. Our prospective, randomized, blinded trial will try to investigate the above by performing nickel skin patch tests to all patients, 14 days before and 90 days after the implantation. During follow-up, clinical manifestations and transthoracic echocardiographic findings will be evaluated and associated with patch skin tests.
NCT06156670
The study will include all patients over 18 years of age who underwent endovascular closure of patent foramen ovale in medical centers in the Russian Federation, who gave written informed consent to the closure and provided personal data as part of inpatient medical care. The project participants will be 29 medical centers in the Russian Federation, where endovascular closure of patent foramen ovale is performed.
NCT05537753
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.
NCT05893758
The objective of this post-market registry is to assess the clinical use of the Lifetech Cera™ PFO Occluder in a real-world and on-label fashion.
NCT06504121
Patent foramen ovale (PFO) has been associated with cryptogenic stroke and transient ischemic attack (TIA) in young adults. Evidence from randomized clinical trials (RCT) has shown that transcatheter PFO closure yields a 59% relative reduction in recurrent ischemic stroke compared to medical therapy in selected individuals. However, the follow-up duration in these studies averaged around 4 years, while only two studies report a median follow-up beyond 10 years. Considering the relative youth of the patients undergoing this procedure (average age being under 50 years across all studies), we can reasonably anticipate a substantial post-PFO closure lifespan for these individuals. Consequently, it is imperative to gather more extensive long-term follow-up data among PFO closure recipients The PROLONG (PFO tRanscatether Occlusion Long-term Outcomes National Group) is an observational, retrospective, multicenter, national registry including men and women undergoing transcatheter PFO closure, with the aim of assessing the long-term (\>10 years) efficacy and safety of this procedure.
NCT04475510
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
NCT06413147
We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.
NCT04738071
Patent foramen ovale (PFO) is a prevalent cause of ischemic stroke and transient ischemic attack (TIA) in young patients. Its role as a cause of cerebrovascular events in the older population is more controversial because of other competing causes are more frequent in the elderly. Recent randomized controlled trials (RCTs) have shown that PFO closure is associated with a 59% relative risk reduction in the risk of recurrent ischemic stroke. As such, the number of PFO closure procedures are expected to increase substantially in the upcoming years. Real world data (RWD) informing on the medical management, the risk of stroke recurrence, incident atrial fibrillation, and other outcomes in stroke patients with PFO, with and without PFO closure, will become crucial for understanding how results from RCTs are translated into clinical practice globally. The IMPROVE (International Multicenter Patent foRamen OVale \& strokE) Registry is an observational, multicenter, international registry of men and women with an ischemic stroke or TIA. The aim is to enroll 8,800 patient-years at ≥50 sites in ≥20 countries. The IMPROVE Registry will provide important information about the management and related outcomes of patients with ischemic stroke or TIA and PFO throughout different regions of the world and across a wide spectrum of healthcare systems.