Rome

This trial investigates the comparative effectiveness of two beta-blocker drugs, carvedilol and metoprolol succinate, in adults with heart failure with reduced ejection fraction HFrEF who have an implantable cardioverter defibrillator ICD. The study aims to provide clear data on which medication better reduces the risk of ICD therapy, cardiovascular hospitalizations, or cardiovascular death. It is a prospective, multicenter, randomized clinical trial enrolling 2,000 participants across 100 U.S. sites, including an 18-month feasibility phase. Participants currently taking metoprolol succinate will be randomized to either continue this treatment or switch to carvedilol at an equivalent dose. Both groups will have their doses adjusted to the maximum tolerated level as per the study protocol. The feasibility phase will evaluate recruitment, safety, adherence, and retention, while the full study will follow participants for up to three years, assessing clinical outcomes and quality of life. During the study, participants will undergo regular assessments including ICD device checks, laboratory tests, imaging, and surveys on quality of life and anxiety related to ICD shocks. Data collected will include cardiovascular events, healthcare use, medication adherence, and patient-reported outcomes measured at baseline and throughout the follow-up. The trial will also analyze results by patient subgroups such as age, sex, race, heart failure type, and ICD type to better understand treatment responses.

Researchers are evaluating the Integrity Implant System in adults with rotator cuff tears of the shoulder. This study aims to confirm the devices performance, safety, and clinical benefit when used to augment rotator cuff tears, with or without repair. The trial focuses on reducing rotator cuff re-tear rates and improving shoulder function through a prospective, multi-center, single-arm, non-randomized post-market clinical follow-up. Participants will receive the Integrity Implant System during rotator cuff tear surgery, which may involve mini-open or arthroscopic approaches. The study will follow patients for up to 24 months after surgery, assessing repair integrity with MRI at 12 months and monitoring other functional outcomes and safety throughout the study period. During the study, participants will complete questionnaires measuring shoulder function, pain, and quality of life at screening, 6 weeks, 6 months, 12 months, and 24 months post-surgery. MRI scans will evaluate tendon repair quality and tissue regeneration. Safety will be tracked by recording adverse events. Participants need to follow rehabilitation instructions and attend all follow-up visits to support comprehensive evaluation of the implants performance.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating the REGENETEN Bioinductive Implant system in patients with high-grade partial-thickness tears of the rotator cuff. The study compares this implant to the standard surgical technique called Completion and Repair to see which approach allows patients to return to their everyday activities faster. The study focuses on functional recovery at 3 months post-treatment and is designed as a randomized controlled trial. Participants receive either the Isolated Bioinductive Repair using the REGENETEN implant or the standard Completion and Repair surgical procedure. These interventions are compared in a parallel-group design. The main study period includes follow-up assessments up to 24 months after surgery, with evaluations at multiple time points that measure shoulder function, pain, tendon healing via MRI, and patient satisfaction. During the study, participants will undergo regular assessments including clinical scores such as the Western Ontario Rotator Cuff WORC index, Constant-Murley Score, and Subjective Shoulder Value SSV. Imaging with MRI will evaluate tendon repair status at 12 months. Researchers will also monitor pain levels, opioid use, physical therapy utilization, and time to return to work, driving, and sports. The primary outcome is the change in WORC score from baseline to 3 months post-intervention, with additional secondary outcomes tracked over 2 years.