Larkspur

Researchers are evaluating the safety and effectiveness of the BWI OMNYPULSE pulsed field ablation PFA system for treating people with symptomatic paroxysmal atrial fibrillation PAF, a condition causing irregular heart rates and abnormal blood flow. This study aims to assess the safety and 12-month effectiveness of this treatment approach in managing PAF symptoms. Participants will receive a pulsed field ablation procedure using the OMNYPULSE catheter combined with the TRUPULSE generator to isolate pulmonary veins and deliver pulsed field energy to treat atrial fibrillation. After the procedure, participants will be followed for 12 months to monitor outcomes related to the treatment. During the study, participants will undergo assessments to measure adverse events within 7 days after the procedure and track freedom from atrial tachyarrhythmia episodes between day 91 and day 365. Researchers will also evaluate changes in quality of life related to atrial fibrillation from the start of the study through 12 months. Participants will be monitored throughout the follow-up period to gather safety and effectiveness data.

This trial is studying how safe and effective the VARIPULSE catheter system is for treating persistent atrial fibrillation PsAF, a heart rhythm disorder. It focuses on participants undergoing catheter ablation procedures that isolate veins in the heart, specifically pulmonary vein isolation PVI and superior vena cava isolation SVCI, with or without posterior wall isolation PWI. The study also looks at safety for participants receiving a left atrial appendage occlusion LAAO procedure during the catheter ablation to reduce stroke risk. Participants will be treated with the VARIPULSE catheter system, which delivers pulsed field ablation, using the VARIPULSE bi-directional catheter and TRUPULSE generator. The study has two groups one undergoing PVI and SVCI, and another undergoing PVI, SVCI, plus PWI. Some participants may also receive the LAAO procedure using commercially available devices as per device instructions. All participants will be followed for up to 36 months after their procedure. During the study, participants will undergo catheter ablation treatment and may receive the LAAO procedure if applicable. Researchers will monitor safety by tracking early adverse events up to 7 days post-procedure and will assess how well the treatment prevents atrial tachyarrhythmia episodes from day 61 to 180 and up to one year. Quality of life will be measured at baseline and 12 months after treatment. Participants need to comply with pre-, post-, and follow-up testing throughout the study and will be observed for up to three years in total.

Researchers are compiling real-world outcomes of the commercially approved Intracept2 Intraosseous Nerve Ablation Systems for treating patients diagnosed with vertebrogenic pain, including those with chronic low-back pain and vertebrogenic pain syndrome. This observational study aims to gather data on how this minimally invasive device performs in routine clinical use. Participants who are scheduled for treatment with the Intracept2 Intraosseous Nerve Ablation System will be observed following their procedure according to local instructions. The study focuses on patients receiving this commercially approved device without altering their treatment plan. Throughout the study, participants will have their disability levels assessed using the Oswestry Disability Index ODI from baseline up to 60 months after the procedure. Data collected will help understand the long-term effects of the device on pain and disability. The total duration of participation may extend up to five years post-treatment.

Researchers are investigating the long-term safety and effectiveness of Abbotts neurostimulation systems in people with chronic pain. This observational study includes a wide range of participants to reflect real-world use and aims to enroll up to 2,000 subjects across up to 100 centers. The study spans 13 years, covering enrollment, data collection, and study closure, with subjects followed for five years after implantation. Participants will receive one of Abbotts market-released neurostimulation devices, either spinal cord stimulation SCS or dorsal root ganglion stimulation DRG. Individuals scheduled for implantation within 60 days of baseline are eligible. The study is single-arm and open-label, meaning all participants receive the device without randomization or placebo control. During the study, researchers will monitor adverse events, deaths, and device issues at multiple time points from baseline through five years post-implant. Participants will undergo regular safety assessments and provide data on device performance and related outcomes. This comprehensive follow-up will help understand the long-term effects and real-world use of these neurostimulation systems.

Researchers are reviewing anonymous medical records from multiple centers to understand the outcomes of different treatments for chronic pain. This study includes several groups to assess how various approaches work in distinct patient subgroups. The focus is on patients who have had or may have spinal cord stimulation systems or other treatments like radiofrequency RF or intradiscal therapies IDS. The study looks at patients who have previously received spinal cord stimulation or other therapies and those who have switched to different treatments afterward. Treatments under review include Boston Scientific devices and non-Boston Scientific systems such as spinal cord stimulation, RF, and IDS. The data is retrospective, meaning it examines past patient experiences without introducing new treatments. Participants involvement consists of the analysis of their de-identified medical charts, with no active treatment or visits required. Researchers will measure responder rates approximately two years from the start of data collection to evaluate treatment outcomes. The study spans from April 2012 to December 2030, focusing on long-term clinical results in chronic pain management.