May 2025 saw several significant developments in the field of cardiology, including new regulatory approvals, long-term clinical trial data and important findings from late-breaking studies. This roundup highlights the latest updates across structural, interventional and heart failure therapies, with implications for clinical practice and ongoing research in mitral valve disease, aortic stenosis, coronary artery disease, transthyretin amyloid cardiomyopathy and hypertrophic cardiomyopathy.

Approvals

FDA Approval of a First-of-its-kind Device to Treat People with Mitral Valve Disease

On 28th May 2025, the FDA approved a first-of-its-kind transcatheter mitral valve replacement (TMVR) system to treat mitral valve disease without open-heart surgery.¹ The device offers a critical new option for those deemed too high-risk for surgery and unsuitable for valve repair with other devices. The approval is backed by clinical data from the SUMMIT trial (ClinicalTrials.gov ID: NCT03433274), a phase III study investigating the safety and effectiveness of the device in  patients with severe mitral annular calcification (MAC).²

MAC is a chronic, degenerative condition characterized by the build-up of calcium deposits in the fibrous ring (annulus) of the mitral valve, leading to impaired valve function and increased risk of cardiovascular complications. This recent approval addresses an unmet need by enabling minimally invasive valve replacement, potentially transforming care in high-risk populations.

FDA Approves SAPIEN 3 TAVR Platform for Asymptomatic Severe Aortic Stenosis, Backed by EARLY TAVR Trial

On 4th May 2025, in a significant advancement for the management of aortic stenosis, the FDA approved the SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for use in asymptomatic patients with severe aortic stenosis (AS); the first FDA approval of its kind.³ This expanded indication, which includes the SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA valves, is supported by pivotal data from the landmark EARLY TAVR trial (ClinicalTrials.gov ID: NCT03042104).⁴ Severe aortic stenosis, a progressive condition characterized by the narrowing of the aortic valve and impaired blood flow from the heart, predominantly affects older adults and, if left untreated, carries a high risk of morbidity and mortality.

The EARLY TAVR trial showed that asymptomatic patients who underwent TAVR had significantly better outcomes than those managed with clinical surveillance.⁵ The findings challenge the long-standing paradigm of “watchful waiting” and suggest a compelling benefit to proactive intervention in high-risk patients before symptoms emerge. The approval may lead to updates in TAVR guidelines and clinical practice by supporting earlier intervention in asymptomatic patients, preventing sudden deterioration and improving long-term outcomes for patients with this life-threatening condition.

Clinical Trial Data

EMPOWER CAD Study Supports IVL-first Strategy in Women with Calcified Coronary Artery Disease 

On 23rd May 2025, 30-day results from the EMPOWER CAD study (ClinicalTrials.gov ID: NCT05755711) provided important real-world evidence supporting the use of an intravascular lithotripsy (IVL)-first strategy in female patients undergoing percutaneous coronary intervention (PCI) for complex, calcified coronary artery disease.^6,7 This prospective, multicentre study is the first of its kind to focus exclusively on women with severe coronary calcification, a population often underrepresented in clinical trials and known to experience higher rates of procedural complications and adverse outcomes with other calcium modification techniques.

The study enrolled 399 patients across 45 sites in Europe and the USA with minimal exclusion criteria, aiming to assess safety and procedural effectiveness in routine clinical practice.⁸ At 30 days, the primary effectiveness endpoint, which was defined as successful stent delivery with ≤30% residual stenosis and no in-hospital target lesion failure (TLF), was achieved in 86.9% of cases (339/390). The primary safety endpoint was TLF within 30 days, including cardiac death, target vessel myocardial infarction, or ischaemia-driven revascularization, of which the rate was 12.1% (48/397). Procedural complications were rare and patients reported statistically significant improvements in health-related quality of life. These findings support IVL as a treatment strategy for women with calcified coronary lesions and may contribute to refining treatment approaches in this underrepresented population.

42-month Data from ATTRibute-CM Extension Study Reinforce Long-term Benefit of Acoramidis in ATTR-CM

On the 20th May 2025, 42-month results from the open-label extension of the ATTRibute-CM phase III trial (ClinicalTrials.gov ID: NCT03860935) provided further evidence supporting the long-term efficacy of acoramidis in patients with transthyretin amyloid cardiomyopathy (ATTR-CM).^9,10 Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive condition in which misfolded transthyretin (TTR) proteins form amyloid deposits in the heart muscle, leading to stiffening of the heart walls, reduced cardiac function and heart failure.

The findings showed that rapid and sustained stabilisation of TTR with acoramidis led to statistically significant reductions in all-cause mortality (ACM) and cardiovascular-related hospitalisations (CVH). The results also demonstrated that greater increases in serum TTR levels are associated with improved clinical outcomes. Furthermore, the sustained benefit observed over 42 months reinforces the role of TTR stabilisation as a key therapeutic target and supports the long-term use of acoramidis as a disease-modifying therapy in both wild-type and hereditary forms of ATTR-CM.

MAPLE-HCM Trial Demonstrates Superiority of Aficamten Over Metoprolol in Obstructive HCM

On May 14th 2025, positive topline results from the phase III MAPLE-HCM trial (ClinicalTrials.gov ID: NCT05767346) were announced.^11,12 These findings showed that aficamten monotherapy led to statistically significant improvements in peak oxygen uptake (pVO₂) at week 24 compared to metoprolol in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Hypertrophic cardiomyopathy (HCM) is a chronic condition where thickened heart muscle impairs blood flow. In obstructive HCM (oHCM), this thickening blocks blood leaving the heart, leading to symptoms like chest pain, breathlessness, dizziness, or fainting, which may vary in severity over time.

The MAPLE-HCM trial was a multicentre, randomized, double-blind, active-comparator study, which enrolled 175 patients who were assigned 1:1 to receive either aficamten or metoprolol over 24 weeks. The primary endpoint was change in pVO_₂, measured by cardiopulmonary exercise testing, and the secondary endpoints included New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, while echocardiographic parameters, such as left ventricular mass index (LVMI) and post-Valsalva left ventricular outflow tract gradient (LVOT-G), were also assessed. The safety and tolerability profile of aficamten was favourable relative to metoprolol. Regulatory review is currently underway in the USA, EU and China.

References

1. Abbott. Abbott receives FDA approval for Tendyne, first-of-its-kind device to replace the mitral valve without open-heart surgery. 2025. Available at: https://abbott.mediaroom.com/2025-05-27-Abbott-Receives-FDA-Approval-for-Tendyne-TM-,-First-of-Its-Kind-Device-to-Replace-the-Mitral-Valve-Without-Open-Heart-Surgery (accessed 2 June 2025).
2. ClinicalTrials.gov. Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT). ClinicalTrials.gov identifier: NCT03433274. Available at: https://clinicaltrials.gov/ct2/show/NCT03433274 (accessed 2 June 2025).
3. Edwards Lifesciences Corporation. Edwards TAVR Receives FDA Approval for Patients With Asymptomatic Severe Aortic Stenosis. 2025. Available at: https://ir.edwards.com/news/news-details/2025/Edwards-TAVR-Receives-FDA-Approval-for-Patients-With-Asymptomatic-Severe-Aortic-Stenosis/ (accessed 2 June 2025).
4. ClinicalTrials.gov. EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis (EARLY TAVR). ClinicalTrials.gov identifier: NCT03042104. Available at: https://clinicaltrials.gov/study/NCT03042104 (accessed 2 June 2025).
5. Généreux P, Schwartz A, Oldemeyer JB, et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2025;392:217. DOI: 10.1056/NEJMoa2405880
6. Medthority. IVL proves effective in women. 2025. Available at: https://www.medthority.com/news/2025/5/shockwave-medical-study-confirms-benefit-of-ivl-first-strategy-in-real-world-female-patients-with-complex-calcified-lesions—johnson–johnson/ (accessed 2 June 2025).
7. ClinicalTrials.gov. Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD). ClinicalTrials.gov identifier: NCT05755711. Available at: https://clinicaltrials.gov/study/NCT05755711 (accessed 2 June 2025).
8. Shockwave Medical. EMPOWER CAD. 2025. Available at: https://shockwavemedical.com/en-eu//clinical-evidence/empower-cad/ (accessed 2 June 2025).
9. Medthority. Acoramidis raises TTR levels. 2025. Available at: https://www.medthority.com/news/2025/5/early-and-sustained-increase-in-serum-ttr-levels-by-acoramidis-independently-predicted-improved-survival-in-the-attribute-cm-study—bridgebio/ (accessed 2 June 2025).
10. ClinicalTrials.gov. Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy (ATTRibute-CM). ClinicalTrials.gov identifier: NCT03860935. Available at: https://clinicaltrials.gov/study/NCT03860935 (accessed 2 June 2025).
11. Globenewswire. Cytokinetics Announces Positive Topline Results From MAPLE-HCM. 2025. Available at: https://www.globenewswire.com/news-release/2025/05/13/3080004/35409/en/Cytokinetics-Announces-Positive-Topline-Results-From-MAPLE-HCM.html (accessed 2 June 2025).
12. ClinicalTrials.gov. Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM (MAPLE-HCM). ClinicalTrials.gov identifier: NCT05767346. Available at: https://clinicaltrials.gov/study/NCT05767346 (accessed 2 June 2025).

Further content in cardiovascular disease.

Editor: Victoria Jones, Senior Content Editor.

Disclosures: This article was created by the touchCARDIO team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.

Cite: May 2025 Cardiology Roundup: Latest Approvals and Clinical Trial Updates. touchCARDIO. 3 June 2025.

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