It is essential for clinicians to remain informed about emerging clinical trial opportunities and recent outcomes that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.
Today’s rundown features clinical trials focusing on or related to valvular heart disease. We split the trials into two distinct groups: currently active and recently completed (within the past few years). Some of today’s featured trials focus on valvular heart disease broadly while others focus on specific types including aortic valve stenosis and mitral regurgitation. Trials are arranged by their start date.
Quick View Tables of Valvular Heart Disease Clinical Trials
| Active Studies | Phase | Estimated Enrollment | Start Date | Anticipated Primary Completion |
|---|---|---|---|---|
| Patient Quality of Recovery After TAVR With Different Sedation Regimens | 4 | 126 | March 2026 | April 2028 |
| Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study (KATALYST-AV) | 2,3 | 1276 | June 2025 | August 2028 |
| A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis | 2 | 502 | March 2024 | March 2030 |
| Use of Phenylephrine for Assessment of Mitral Regurgitation Severity | 1,2 | 35 | December 2020 | June 2026 |
| Recently Completed Studies | Phase | Enrollment | Start Date | Primary Completion |
|---|---|---|---|---|
| Sugammadex Titration in Cardiac Surgery Patients | 4 | 100 | February 2022 | November 2022 |
| Effects of Microplegia on Transfusion Rates After Cardiac Surgery | 4 | 314 | March 2019 | June 2023 |
| 18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes | 2 | 20 | July 2017 | October 2023 |
Featured Active Clinical Trials
Patient Quality of Recovery After TAVR With Different Sedation Regimens
- Sponsor: David Lyubashevsky
- Goal: The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure.
- Interventions: Propofol, dexmedetomidine, midazolam, fentanyl
- Primary Outcome Measure: Quality of recovery on postoperative day 1 measured by QoR-15 survey.
- Time Frame: From baseline assessment prior to transcatheter aortic valve replacement (TAVR) through postoperative day.
- Study Details
- Source
Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study (KATALYST-AV)
- Sponsor: Kardigan
- Goal: The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
- Interventions: Ataciguat, placebo
- Primary Outcome Measures: (Part A) Change in aortic valve calcium (AVC) score as assessed by non-contrast CT from baseline to week 24; (Part B Dual-Primary) Percent change in aortic valve area (AVA) as measured by echocardiogram from baseline to week 48; (Part B Dual-Primary) Change in peak VO2 by CPET from baseline to week 48.
- Time Frames: Week 24; Week 48; Week 48.
- Study Details
- Source
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
- Sponsor: Novartis Pharmaceuticals
- Goal: The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
- Interventions: Pelacarsen (TQJ230) 80mg, matching placebo
- Primary Outcome Measures: Change in peak aortic jet velocity; Change in aortic valve calcium score.
- Time Frames: 36 months; 36 months.
- Study Details
- Source
Use of Phenylephrine for Assessment of Mitral Regurgitation Severity
- Sponsor: Montefiore Medical Center
- Goal: The study proposes to develop a phenylephrine protocol to be used during transesophageal echocardiography, whereby intravenous phenylephrine would be used to increase afterload with the intent to mimic the awake hemodynamic profile and variation that occurs with normal physical activity.
- Interventions: Mydfrin
- Primary Outcome Measure: The percentage of patients with greater than 25% increase in MR regurgitant volume (Rvol) after the use of phenylephrine during transesophageal echocardiography.
- Time Frame: Before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes.
- Study Details
- Source
Featured Recently Completed Clinical Trials
Sugammadex Titration in Cardiac Surgery Patients
- Sponsor: University of Washington
- Goal: The purpose of this [study] is to determine the minimal effective dose of sugammadex by administering 50 mg every 5 minutes until the train-of-four ratio is 0.9 in a cohort of cardiac surgery patients, and to determine the duration of action by measuring the train-of-four every hour for up to 6 hours following reversal.
- Interventions: Sugammadex
- Primary Outcome Measures: Total dose of sugammadex required to produce a train-of-four ratio of >0.9, categorized as greater than or less than the manufacturer's recommended dose based on the train-of-four or post tetanic response prior to administration of sugammadex; Duration of action of reversal.
- Time Frames: At the completion of surgery and prior to transport to the intensive care unit. The elapsed time from completion of surgery to arrival in the intensive care unit is 30 min to one hour; On arrival to the intensive care unit and hourly thereafter for six hours or until extubation, whichever occurs first.
- Study Details
- Source
Effects of Microplegia on Transfusion Rates After Cardiac Surgery
- Sponsor: Washington University School of Medicine
- Goal: This is a prospective, randomized study that is studying the rate of red blood cell (RBC) transfusion rates after planned heart (cardiac) surgery.
- Interventions: Cardioplegia solution, microplegic solution No. 1
- Primary Outcome Measures: Intraoperative and postoperative transfusions.
- Time Frames: Intraoperative (time in operating room), postoperative (from transfer from operating room to intensive care unit to 30 days).
- Study Details
- Source
18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
- Sponsor: Cedars-Sinai Medical Center
- Goal: This is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters.
- Intervention: 18F-NaF
- Primary Outcome Measure: Presence of calcification activity within the replacement valve by 18F-NaF PET-CT.
- Time Frame: Baseline.
- Study Details
- Source
Related Guidelines:
- Management of Valvular Heart Disease
- European Society of Cardiology (ESC), European Association for Cardio Thoracic Surgery (EACTS)
- August 2025
- Management of Patients with Valvular Heart Disease
- American College of Cardiology (ACC), American Heart Association (AHA)
- December 2020
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