Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

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Description Module


Ignite Creation Date: 2025-12-25 @ 2:02 AM
Ignite Modification Date: 2025-12-25 @ 2:02 AM
NCT ID: NCT06696560
Brief Summary: To compare intraoperative and immediate postoperative outcomes of mini-sternotomy versus mini-thoracotomy as less invasive techniques in patients with isolated aortic valvular and subvalvular disease requiring surgery according to inclusion criteria.
Detailed Description: 1. It has been demonstrated that minimally invasive aortic valve replacement (MIAVR) approaches are safe and effective for the treatment of aortic valve diseases. To date, the main advantage of these approaches is represented by the reduced surgical trauma, with a subsequent reduced complication rate and faster recovery. This makes such approaches an appealing choice also for frail patients \[obese, aged, chronic obstructive pulmonary disease (COPD)(1). 2. Minimally invasive aortic valve replacement (MIAVR) has been increasingly accepted in the surgical community as a potential alternative to conventional sternotomy, with advantages of reduced trauma, improved cosmotic and reduced hospitalization(2). 3. The Mini sternotomy (MS) approach represents the most common technique used for Minimally invasive AVR. The MS approach is achieved through 6 to 10cm midline vertical skin incision, performing a partial J sternotomy at the third to fifth intercostal space (3). MIAVR via right mini thoracotomy (RT) is performed through five to seven cm skin incision placed at the level of the second intercostal space without rib resection. After sacrificing the right internal thoracic artery(4). 4. Despite these excellent results, there have been an increasing number of cases performed via minimally invasive aortic valve replacement (MIAVR). This approach has now become an established alternative to FS in order to reduce the "invasiveness" of the surgical procedure, while maintaining the same efficacy, quality and safety of a conventional approach (5).
Study: NCT06696560
Study Brief:
Protocol Section: NCT06696560