NCT03813511

Sleep-Disordered Breathing in Patients With Severe Valvular Regurgitation Undergoing Clip Procedure

Prevalence and Dynamics of Sleep-Disordered Breathing (SDB) in Patients With Severe Valvular Regurgitation and High Surgical Risk Undergoing Minimally Invasive Clip Procedure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Heart and Diabetes Center North-Rhine Westfalia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In a prospective observational study, the investigators investigate the prevalence of sleep disordered breathing in patients with severe valvular regurgitation and the effect of using the minimal invasive Clip technique on sleep disordered breathing.

Detailed description

The purpose of this study is to analyze the prevalance of sleep disordered breathing in patients with severe valvular regurgitation and the impact of a therapy with the minimal-invasive Clip technique. Therefore, the investigators want to include consecutive patients with unknown sleep-associated respiratory distress syndrome and, in addition, as a study-specific achievement, the investigators want to obtain the quality of life and specific symptoms of the patients by using established questionnaires. After three month of post-interventional care, the patients will get a post-interventional check-up in our cardiological outpatient clinic, where the course of sleep-associated respiratory distress syndrome and the actual quality of life and specific symptoms will be documented by using a cardiorespiratory polygraphy and the same questionnaires. The entire hospital stay, including possible post-interventional complications, will be documented for this study from the patients' medical records. The routine examinations (laboratory values, ECG, 6-minute walk test, pulmonary function examinations, spiroergometry, transthoracic / -oesophageal echocardiography, etc.) shall also be recorded in the database of this study. The plan is to include 100 evaluable patients with complete follow-up and the associated test results. For this purpose, a screening of 150 patients is expected to be required.

Conditions

• Sleep Disordered Breathing
• Valvular Regurgitation

Timeline

• Start date: 2018-12-01
• Primary completion: 2022-03-14
• Completion: 2022-07-31
• First posted: 2019-01-23
• Last updated: 2023-03-06

Locations

1 site across 1 country: Germany