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

NCT03813511 | Completed

• 1 other identifier: HDZ-KA_015_MG
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disordered Breathing; Valvular Regurgitation

Keywords

Minimally invasive surgery; Clip procedure

Outcome Measures

Primary Outcomes (11)

• Prevalance of Sleep disordered breathing in Patiens with severe valvular regurgitation

  Proportion of of Sleep disordered breathing in Patiens with severe valvular regurgitation in a given time period

  3 month

• Influence of the minimal invasive Clip technique on apnea-hypopnea index

  Changes on the number of apnea and hypopnea events per hour of sleep due to the minimal invasiv Clip technique

  3 month

• Influence of the minimal invasive Clip technique on apnea index

  Changes on the number of apnea events per hour of sleep due to the minimal invasiv Clip technique

  3 month

• Influence of the minimal invasive Clip technique on the oxygen desaturation index

  Changes on the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline due to the minimal invasiv Clip technique

  3 month

• Influence of the minimal invasive Clip technique on T90

  Changes on the the percentage of time during which arterial O2 saturation was less than 90% (T90) due to the minimal invasiv Clip technique

  3 month

• Influence of the minimal invasive Clip technique on sleep cycle length

  Changes on the duration of the five stages of sleep (in minutes) due to the minimal invasiv Clip technique

  3 month

• Influence of the minimal invasive Clip technique on ventilation length during sleep

  Changes on the ventilation length (in seconds) due to the minimal invasiv Clip technique

  3 month

• Influence of the minimal invasive Clip technique on PISA in tranthoracic echocardiography

  Changes on the proximal isovelocity hemispheric surface area (PISA in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique

  3 month

• Influence of the minimal invasive Clip technique on the effective regurgitant orifice (ERO) in tranthoracic echocardiography

  Changes on the effective regurgitant orifice (ERO in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique

  3 month

• Influence of the minimal invasive Clip technique on the peak velocity of the mitral regurgitant jet (mR-Vmax) in tranthoracic echocardiography

  Changes on the peak velocity of the mitral regurgitant jet (mR-Vmax in meter per seconds) in tranthoracic echocardiography due to the minimal invasiv Clip technique

  3 month

• Influence of the minimal invasive Clip technique on the myocardial perfomance index (TEI-index) in tranthoracic echocardiography

  Changes on systolic and diastolic time intervals in expressing global systolic and diastolic ventricular function (without unity) in tranthoracic echocardiography due to the minimal invasiv Clip technique

  3 month

Secondary Outcomes (9)

• Post-interventional changes in daytime sleepiness with and without sleep disordered breathing

  3 month

• Post-interventional survey of patient health with and without sleep disordered breathing

  3 month

• Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure

  3 month

• Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing

  3 month

• Post-interventional assessment of the sleep quality with and without sleep disordered breathing

  3 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stationäre patients with severe valvular regurgitation and currently unknown sleep disorder breathing who will be treated with a minimal invasive Clip technique

You may qualify if:

• Patients with severe valvular regurgitation and currently unknown sleep disorder breathing who will be treated with a minimal invasive Clip technique

You may not qualify if:

• Patients with more then one valvular disease which requires Treatment
• Patients with complex congenital heart disease
• Pregnant women

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Muhammed Gercek, MD

  Heart and Diabetes Center North Rhine-Westphalia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 23, 2019
• Study Start: December 1, 2018
• Primary Completion: March 14, 2022
• Study Completion: July 31, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)