Selected data models

You must log in to select data models for download or further analysis.

3 Search results.
Relevance Rating New first Old first

Sleep Apnea Monitoring and Atrial Fibrillation NCT01922726 - Eligibility Criteria

- 5/14/19 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients (RESPIRE); ODM derived from: https://clinicaltrials.gov/show/NCT01922726 Brief Summary: The purpose of the study is to evaluate at 12 Months follow-up the association between Atrial Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in REPLY 200 DR pacemaker. Detailed Description: The object of the investigation relates to the function named Sleep Apnea Monitoring or SAM function. This function is part of the REPLY 200 DR pacemakers, whose intended use is cardiac pacing. Sleep Apnea Syndrom (SAS) causes serious social and economic problems, not only because of its high prevalence but also because it is associated with increased cardiovascular morbidity and mortality. Patients with Sleep Apnea often have arterial and pulmonary hypertension, a high risk of coronary artery disease, and heart failure, whereas a high percentage of patients show heart rhythm disturbances. In addition, these patients are at increased risk of being involved in traffic accidents, as well as suffering a decline in their family, social, and professional lives. Therefore, the prompt diagnosis of these patients could be of great importance. Today the gold standard for the diagnosis of SAS is overnight polysomnography (PSG) in a sleep laboratory. However, the shortage of sleep laboratories and the high cost of PSG render this method inadequate for widespread screening. For these reasons, in recent years, there have been attempts to develop alternative diagnostic with a view to simplify the diagnosis. Thanks to the feature SAM included in the pacemaker, sequences of respiratory cycles are analyzed to detect, to count and to report abnormal breathing events during the night. This analysis is based on the Minute Ventilation (MV) signal. The MV signal represents the real time expansion/contraction of the thorax of the patient. It is derived of the transthoracic impedance periodic measurements. The device is able to provide the physician with day-by-day Respiratory Disturbance Index (RDI) equal to the sum of events divided by the number of hours per night. Physician will also access to the total number of events over the previous night presented per hour.

Estimation of Dose Proportionality of Darapladib - 107038 - Follow-Up: 12-lead ECG Abnormalities

- 11/13/18 - 1 form, 8 itemgroups, 87 items, 1 language
Itemgroups: Administrative data, Record clinically significant abnormalities below., A. Rhythm, B. P-Wave Morphology, C. Conduction, D. Myocardial Infraction, E. Depolarisation/Repolarisation (QRS-T), F. Other
Study ID: 107038 Clinical Study ID: LPL107038 Study Title: Study to Estimate the Dose Proportionality of the Enteric-Coated Freebase Formulation of SB-480848 Patient Level Data:  Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: Tyrisa ,US Study Indication: Atherosclerosis

Eligibility Bradycardia NCT01912326

- 6/26/16 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation; ODM derived from: https://clinicaltrials.gov/show/NCT01912326

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial