Fall River

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 treatment in adults with primary hypothyroidism who are currently stable on synthetic T4. The study focuses on assessing how well patients respond to dose conversion from synthetic T4 therapy to Armour Thyroid. This trial is conducted as a Phase 2/3 multicenter, double-blind, randomized, active-controlled study. Participants receive either Armour Thyroid in oral capsule or tablet form or synthetic T4 capsules. They must have been on a stable dose of synthetic T4 for at least 12 months before screening, with a dose of at least 25 mcg daily. The study compares both treatments over time to evaluate efficacy and safety in maintaining thyroid function. During the study, researchers monitor thyroid-stimulating hormone (TSH) levels to measure treatment response at week 55. They also track any adverse events related to the treatments for up to approximately 90 weeks. Participants undergo regular assessments to ensure safety and effectiveness throughout the study period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of TP-05 in healthy adults who are at high risk of tick exposure and Lyme disease. This Phase 2b randomized, double-blind, placebo-controlled study aims to understand how TP-05 performs compared to a placebo in preventing Lyme borreliosis. The study enrolls adults aged 18 to 70 years who are overtly healthy and able to comply with study procedures. Participants will be randomly assigned to receive either a low dose or high dose of TP-05 or a matching placebo, all administered orally according to a predefined dosing schedule. The study includes a screening period, a treatment period lasting up to 24 weeks, and a safety follow-up period. During treatment, participants will be monitored closely for any adverse effects and signs of Lyme borreliosis. Throughout the study, participants will undergo safety assessments including monitoring of adverse events, clinical laboratory tests, vital signs, physical exams, and electrocardiograms. Researchers will follow participants for approximately 15 months to track safety outcomes and any tick bites or symptoms of Lyme disease. Key measures include changes from baseline in laboratory results, vital signs, and ECG parameters, ensuring thorough safety evaluation over the study course.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are evaluating the safety and effectiveness of the Sphere-360 Pulsed Field Ablation Catheter combined with the Affera Mapping and Ablation System for treating adults with paroxysmal atrial fibrillation (PAF). This prospective, single-arm, pre-market clinical study plans to enroll up to 300 participants across 26 sites in the United States. The study focuses on patients with recurrent symptomatic PAF and aims to analyze freedom from atrial tachyarrhythmia recurrence and the incidence of device- and procedure-related serious adverse events. Participants will undergo pulmonary vein isolation using the Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System. The study does not involve comparator groups since it is a single-arm trial. No site will enroll more than 15% of the total participants to maintain diversity. The treatment procedure and device are monitored closely throughout the study period. During the study, participants will be followed for up to 12 months to assess recurrence of atrial tachyarrhythmia after the initial ablation procedure. Safety will be monitored for six months post-ablation to track any serious adverse events related to the device or procedure. Participants will undergo baseline and follow-up evaluations as required to assess treatment outcomes and overall health status throughout the study.

Researchers are conducting a global, multi-center, non-randomized observational trial to evaluate the PulseSelect™ PFA System in adults with recurrent symptomatic paroxysmal or persistent atrial fibrillation who have not responded to at least one Class I or III antiarrhythmic drug. The study aims to observe safety and effectiveness outcomes over a 36-month period following the ablation procedure. Participants will undergo an ablation procedure using the commercially available PulseSelect™ PFA System according to each hospital's standard of care. After the procedure, study visits are scheduled at 3, 6, 12, 24, and 36 months, with required 24-hour Holter monitoring at 6, 12, 24, and 36 months to assess heart rhythm. During the study, researchers will track freedom from atrial fibrillation and monitor for any device or procedure-related adverse events, especially within the first 6 months post-ablation. Participants will be followed for up to 36 months to evaluate long-term outcomes and safety of the PulseSelect™ PFA System.

This research focuses on evaluating the safety and effectiveness of the FARAWAVE and FARAPOINT pulsed field ablation (PFA) catheters for retreating persistent atrial fibrillation (PersAF) after an initial ablation procedure did not succeed. The study is prospective, single-arm, open-label, and conducted at multiple centers, aiming to study symptomatic patients with PersAF. The trial specifically investigates the use of the FARAPULSE PFA System in this context. Participants will be treated using the FARAPULSE Pulsed Field Ablation System, which includes the FARAWAVE catheter for isolating pulmonary veins and the posterior wall, and the FARAPOINT catheter used as an adjunct for creating ablation lines such as the mitral isthmus. The intervention targets patients with persistent atrial fibrillation lasting no longer than 12 months. This study does not use a control group and focuses on the application of the PFA system in one treatment arm. During the study, researchers will monitor safety over 60 days and assess acute procedural success within 24 hours post-treatment. Participants will undergo follow-up assessments and testing at approved clinical centers to evaluate the outcomes. The study involves collecting data on symptomatic recurrence of atrial fibrillation, procedural safety, and effectiveness of the ablation system.

Researchers are evaluating two different heart pacing methods to treat heart failure classified as NYHA II to IV. The study compares the current standard method, Cardiac Resynchronization Therapy (CRT), which uses a pacing lead implanted in a vein on the surface of the left lower heart chamber (left ventricle), with an alternative method called Left Bundle Branch Area Pacing (LBBAP). The LBBAP lead is FDA-approved for implantation in the left bundle branch area but not yet approved specifically for heart failure treatment. Participants are randomly assigned to receive either the standard CRT-D device system with a quadripolar left ventricular lead or a CRT-D system with an INGEVITY+ pace/sense lead implanted in the left bundle branch area. Both interventions involve implanting right atrial and defibrillation leads. The study will follow participants for up to five years to assess outcomes related to mortality, heart transplant, device therapy events, and system complications. During the study, participants will undergo regular evaluations including monitoring of health outcomes such as heart failure events, ventricular arrhythmias requiring therapy, and system-related complications. The primary outcomes focus on a composite of serious cardiac events over the full study period and complication-free device use at 12 months. Participants must agree to remote patient monitoring and commit to follow-up visits and testing at approved study sites throughout the trial period.

Researchers are studying the long-term safety, functional outcomes, and performance of the Indigo Aspiration System in treating pulmonary embolism (PE), a condition where blood clots block arteries in the lungs. This study aims to assess real-world results and gather data on how well this device works and its safety profile over time. The study uses the Indigo Aspiration System as a frontline endovascular treatment for patients with acute PE who meet specific criteria, such as having symptoms for 14 days or less and a right ventricle to left ventricle (RV/LV) ratio of 0.9 or higher. Participants must be at least 18 years old and receive treatment according to the device's instructions for use. The primary outcomes include measuring major adverse events and changes in the RV/LV ratio within 48 hours after the procedure. Participants will be evaluated through clinical assessments and imaging tests like computed tomographic angiography or echocardiograms to monitor heart function and treatment safety. Researchers will collect data on adverse events and the device's performance shortly after treatment. The study involves informed consent and follows ethical guidelines, with ongoing monitoring to understand long-term effects and safety.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.