Rome

Researchers are evaluating the effects of two beta-blockers, carvedilol and metoprolol succinate, in patients with heart failure with reduced ejection fraction (HFrEF) who have an implantable cardioverter defibrillator (ICD). This multicenter, open-label, randomized clinical trial, called CARVTOP-ICD, will enroll 2,000 participants across 100 U.S. sites. The study includes an 18-month feasibility phase with 100 participants from 15 sites to assess study processes and patient engagement. The goal is to compare clinical outcomes and provide evidence to guide beta-blocker choice in this patient population. Participants currently treated with metoprolol succinate and having an ICD implanted for primary prevention will be randomly assigned in a 1:1 ratio to either continue metoprolol succinate or switch to an equivalent dose of carvedilol. Both drugs will be titrated to the maximum tolerated dose as per the study protocol. The feasibility phase focuses on recruitment, medication switching, safety, adherence, and retention. After randomization, participants will be followed for up to 3 years with regular assessments, including medication adherence and quality of life. Participants will receive assessments at baseline, 2 and 4 weeks, and quarterly visits thereafter. Evaluations include ICD interrogations, cardiac imaging, laboratory tests, heart failure classification, medication use, adverse events, and patient-reported outcomes through questionnaires. The main outcome measured is the first occurrence of ICD therapy, cardiovascular hospitalization, or cardiovascular death within 3 years. Secondary outcomes include ICD shock burden, healthcare utilization, and quality of life. The study will also analyze subgroups by sex, age, race, heart failure cause, ICD type, and heart function.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the functional recovery of patients with high-grade partial thickness rotator cuff tears, specifically those with tears greater than 50% or more than 6mm, using either the REGENETEN14 Bioinductive Implant or the standard surgical repair technique called Completion and Repair. The study aims to determine if the bioinductive implant helps patients return to their normal activities faster compared to the standard repair. This is a prospective, multicenter, randomized controlled trial focusing on safety and efficacy in treating these shoulder injuries. Participants will receive one of two treatments: either Isolated Bioinductive Repair using the REGENETEN14 Bioinductive Implant device or Completion and Repair, which is the standard surgical method. Both treatments are designed to manage the partial thickness tears of the supraspinatus tendon or supraspinatus with infraspinatus. The study monitors patients for at least three months post-intervention to compare recovery outcomes between the two methods. During the study, patients will attend scheduled visits where their recovery and function will be assessed. Researchers will measure changes in the Western Ontario Rotator Cuff (WORC) score from baseline to three months after treatment to evaluate shoulder function improvement. Participants must be able to follow study instructions and complete questionnaires. Safety and efficacy data will be collected throughout the study to understand the benefits and risks of each treatment approach.