Larkspur

Researchers are evaluating the safety and effectiveness of the BWI OMNYPULSE123 pulsed field ablation (PFA) system, including the OMNYPULSE123 catheter and TRUPULSE123 generator, for treating people with symptomatic paroxysmal atrial fibrillation (PAF). PAF is an irregular heart rhythm that affects blood flow, and this study aims to demonstrate the safety and 12-month effectiveness of this treatment for pulmonary vein isolation (PVI). Participants will receive treatment using the OMNYPULSE123 catheter with the TRUPULSE123 generator for pulsed field ablation. The study focuses on using this device to isolate pulmonary veins as a method to manage paroxysmal atrial fibrillation. The procedures and device usage are designed to be evaluated over a 12-month period following the treatment. During the study, participants will be monitored for adverse events within 7 days after the procedure and will be assessed for freedom from atrial tachyarrhythmia episodes (including atrial fibrillation, atrial tachycardia, or atrial flutter) from day 91 to day 365 post-procedure. Researchers will conduct follow-up visits and tests to evaluate safety and treatment outcomes over the full year after treatment.

Researchers are compiling real-world results of the Intracept™ Intraosseous Nerve Ablation System, which is a commercially approved device used to treat patients with vertebrogenic pain, a cause of chronic low-back pain. The study aims to understand how this minimally invasive procedure performs in everyday medical practice for those diagnosed with vertebrogenic pain syndrome. Participants receive treatment using the Intracept™ Intraosseous Nerve Ablation device according to local instructions for use. This procedure is designed to address vertebrogenic back pain by targeting affected nerves within the bone structure. The study focuses on patients who are already scheduled for this therapy in routine clinical care. During the study, researchers will observe participants over time and measure changes in disability related to back pain using the Oswestry Disability Index, with follow-up assessments reaching up to 60 months after the procedure. The study collects data on how patients respond to the treatment in real-world settings, aiming to gather long-term outcomes and safety information.

Researchers are conducting the REALITY study to collect both short- and long-term safety and effectiveness data on people implanted with Abbott's neurostimulation systems for chronic pain. This prospective, open-label, multi-center study includes a broad range of participants to reflect real-world use and aims to enroll up to 2,000 subjects across up to 100 centers. Enrollment is planned to be completed within 7 years, with an overall study duration of 13 years including follow-up and close out. Participants will receive market-approved Abbott neurostimulation devices, specifically spinal cord stimulation (SCS) or dorsal root ganglion stimulation (DRG) systems. Individuals scheduled to receive implantation within 60 days of the baseline visit can join the study. The study does not randomize or compare treatments but monitors the implanted devices over time to gather safety and performance information. During the study, participants will be followed for up to 5 years after implantation with regular assessments to track device- and procedure-related adverse events, deaths, and device deficiencies. These safety outcomes will be measured at multiple time points including baseline, the permanent implant procedure, and every six months up to five years. The study also involves collecting data on patient experience and device performance throughout this period.

This research evaluates anonymous, previously collected medical data to review the outcomes of different treatment methods for chronic pain. The study is a retrospective review involving multiple centers and independent patient groups to compare results across various subgroups. The study examines clinical outcomes related to the use of spinal cord stimulation, radiofrequency (RF), and other implantable device systems from Boston Scientific and other manufacturers. Multiple cohorts will be analyzed based on the type of treatment system used. Participants' medical charts will be reviewed to measure response rates through approximately two years of follow-up. The study focuses on clinical results documented in patient records without any new treatment or intervention administered during the study.