HonorHealth Research Institute has achieved a major milestone with the world’s first artificial mitral heart valve that requires no open-heart surgery. Extensively tested for eight years at our Institute, the innovative Tendyne replacement mitral valve was recently approved by the U.S. Food and Drug Administration on May 27, 2025. Created by Illinois-based Abbott, the device marks a massive leap forward for cardiovascular care.

David Rizik, MD, medical director of the Cardiovascular Research Division, emphasized the importance of this achievement: “Approval of this device represents another milestone in the history of HonorHealth Research Institute achievements and our continuing efforts to provide the very latest in medical technology and quality care for our patients.” This breakthrough truly highlights our dedication to providing the latest treatments to patients through rigorous clinical research and collaboration with leading medical device companies.

Current clinical trial opportunities

Oncology

RMC-GI-102: A platform study of RAS(ON) inhibitors

• Focus: Gastrointestinal solid tumors.
• Objective: To determine if the study drug combination is superior to standard of care therapy.
• Eligibility: Patients 18 or older, must be able to take oral medication and willing to keep a diary. Includes those with confirmed pancreatic ductal adenocarcinoma or poorly differentiated pancreatic carcinoma with documented metastatic disease, or colorectal adenocarcinoma with documented unresectable or metastatic disease.

Werewolf WXT330x2102: A Phase 1b/2 study of WTX-330

• Focus: Selected advanced or metastatic solid tumors or Non-Hodgkin Lymphoma.
• Objective: Evaluate the safety, tolerability and dose/regimen of the treatment.
• Patient benefit: Treatment can continue as long as clinical benefits are observed.
• Eligibility: Patients 18 or older with a minimum body weight of 103 pounds (47 kg) and a confirmed diagnosis of metastatic tumor. CNS tumors are ineligible.

Cardiovascular

CONFORMAL: CLAAS system evaluation

• Focus: Non-valvular atrial fibrillation (Afib).
• Objective: Compare the CLAAS system to other commercially available LAAO devices.
• Eligibility: Patients diagnosed with non-valvular Afib, at increased stroke risk, recommended for oral anticoagulation and willing to comply with medication regimen and follow-up.
• Contact: Rahul Doshi, MD, or send an ambulatory research referral via Epic.

SIMPLAAFY: WATCHMAN FLXT Pro device trial

• Focus: Patients with AF after WATCHMAN FLXT Pro device implant.
• Objective: Assess if a less intensive drug regimen mitigates post-implant bleeding risk and offers viable post-implant treatment options.
• Eligibility: Patients with increased stroke/systemic embolism risk based on CHA2DS2-VASc scores, recommended for anticoagulation, deemed suitable for oral anticoagulation (OAC) and with a rationale for seeking a non-pharmacologic alternative to OAC.
• Contact: Yoaav Krauthammer, MD, or send an ambulatory research referral via Epic.

Bariatric/GI

PATENT-E: Paclitaxel-coated balloon for esophageal stricture

• Focus: Chronic benign esophageal stricture.
• Eligibility: Patients 22 or older with a diagnosis of benign esophageal stricture (at least two previous dilations) and an Ogilvie Dysphagia Score of 2 or greater.
• Contact: Victoria Staenglen at [email protected] or 480-323-1292.

PATENT-B: Paclitaxel-coated balloon for bowel stricture

• Focus: Chronic benign bowel stricture.
• Eligibility: Patients 22 or older with a diagnosis of symptomatic benign bowel stricture (at least two previous dilations) and a stricture length of five centimeters or less.
• Contact: Victoria Staenglen at [email protected] or 480-323-1292.

REMAIN-1: Revita duodenal mucosal resurfacing (DMR) for weight maintenance

• Study duration: 1.5 years
• Objective: Determine if DMR helps maintain weight loss achieved with a GLP-1-based drug.
• Eligibility: Patients 21 to 70 without Type 1 or Type 2 diabetes. Prior to tirzepatide therapy (provided in study), BMI must be between 30 and 45 kg/m2. Patients must not have used any GLP-based drug within six months or any other oral or injectable hypoglycemic or weight loss medications (prescription or OTC) within three months prior to screening.
• Contact: Victoria Staenglen at [email protected] or 480-323-1292.

Multispecialty

Phase 2/3 study of belimumab for systemic sclerosis-associated interstitial lung disease (SSC-ILD)

• Design: Randomized, double-blind, placebo-controlled, parallel-group.
• Objective: Evaluate efficacy and safety of subcutaneously administered belimumab in adults with SSC-ILD.
• Eligibility: Patients 18 or older with diffuse cutaneous disease, defined by thickened skin with a modified Rodnan Skin Score greater than – over at least one skin area proximal to the elbows or knees, in addition to distal area involvement on day one.

Phase 3 program: Upadacitinib in systemic lupus erythematosus (SLE)

• Objective: Evaluate the safety and efficacy of upadacitinib in subjects with moderately to severely active SLE.
• Eligibility: Patients 18 to 63 with a clinical diagnosis of SLE at least 24 weeks prior to screening, as defined by 2019 EULAR/ACR classification criteria for SLE.
• Contact: Aubrey Gonzales at [email protected] or 480-583-7423.

Neuroscience

Novartis CLNP023Q12301: Iptacopan in myasthenia gravis (MG)

• Design: Randomized, double-blind study.
• Objective: Evaluate safety and efficacy of iptacopan in MG patients.
• Follow-up: Patients completing the double-blind period can enroll in the open-label extension.
• Contact: Kristy Osgood at [email protected].

TAK-881-3003: Pharmacokinetics of TAK-881 and HYQVIA in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

• Design: Single-arm trial.
• Objective: Evaluate pharmacokinetics of TAK-881 and HYQVIA in multiple doses in CIDP patients.
• Contact: Rebecca Otutoa at [email protected].

Refer patients today

These clinical trials offer hope and new possibilities for patients seeking innovative therapies not yet available through standard care. When considering referrals, review eligibility criteria carefully and use Epic for cardiovascular studies or contact coordinators directly. Consider trials for patients with refractory conditions or those seeking advanced options.

For questions or to learn more about the HonorHealth Research Institute and its many clinical trials, visit HonorHealth.com/research.

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