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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

This research aims to assess the long-term safety and performance of the Lifetech HeartR PDA Occluder device in patients diagnosed with Patent Ductus Arteriosus PDA treated in real-world clinical practice settings in Indonesia. The study is retrospective and single-arm, enrolling 140 subjects who have received the HeartR PDA Occluder according to the devices instructions for use. The main goal is to understand how well the device works and its safety over time in everyday medical use. The study involves patients who were implanted with the HeartR PDA Occluder device via a transcatheter procedure for PDA closure. Eligible patients are those aged 6 months or older, weighing at least 6 kg, and having a PDA narrowest diameter of 2 mm or more at implantation. The study collects data retrospectively from patients who had follow-up visits after hospital discharge, focusing on device performance and safety outcomes over months to years after implantation. Participants records are reviewed for procedural success at 12 months post-implantation, which includes no major complications and complete defect closure verified by Doppler echocardiography. Secondary outcomes such as closure rates before discharge and at 6 months, incidence of artery stenosis requiring re-intervention, device or procedure-related adverse events, serious adverse events, and overall mortality up to 24 months post-implantation are also evaluated. The study spans data collection until the end of 2026, providing long-term monitoring of outcomes in this patient group.

Age: 6Months +All Genders
1 location
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Actively Recruiting

Researchers are evaluating the real-world effectiveness and safety of Nebilet4 nebivolol in adults with hypertension across seven Asian countries. This multinational, multicenter, observational, and prospective study aims to assess blood pressure changes, treatment adherence, quality of life, prescription patterns, and cardiovascular outcomes over up to three years. The study also compares Nebilet4 used alone versus in combination therapy and investigates the relationship between home and office blood pressure measurements. Participants include about 5,000 adults newly diagnosed with or having uncontrolled hypertension who have recently started Nebilet4 or been on it no more than two weeks. Patients are followed regularly for 12, 24, and 36 months, with blood pressure measured at each visit and home readings encouraged. The study collects data on medication dosing and frequency, adherence, and cardiovascular risk factors, while monitoring major adverse cardiac events such as heart attack, stroke, and cardiovascular death. During the study, participants complete questionnaires to assess quality of life and medication adherence every few months. Data are recorded through an electronic system ensuring consistency across sites. Researchers evaluate changes in systolic and diastolic blood pressure and the proportion achieving target blood pressure goals. Safety and any adverse events are documented, with follow-up visits extending up to three years to provide insights into the long-term management of hypertension with Nebilet4.

Age: 18Years - 100YearsAll Genders
49 locations