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Diagnosis And Treatment of Sleep Apnea in Patient With Heart Failure

NCT02620930 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 265

Last updated 2017-02-23

No results posted yet for this study

Summary

DASAP-HF is an observational prospective single arm study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of consecutive patients from each center, according to eligibility criteria. All patients must sign the Patient Informed Consent (PIC) before the enrollment in the study. All patients, after the enrollment phase, will be followed for 24 months. Approximately every 12 months a clinical follow-up procedure should be performed in each patient. A sleep study will be done in all patients at 1 month (or at 3 months) from the enrollment, in order to evaluate the performance of the algorithm as a diagnostic tool in this population (primary objective). During the 24 months follow-up period, all Adverse Events occurred in the study population will be collected (HF hospitalizations, all-cause deaths, ventricular arrhythmias, etc.). At the end of the 24 months follow-up, the incidence of clinical events will be evaluated as well as its association with the Respiratory Disturbance Index (RDI) values calculated by APNEA Scan algorithm (secondary objective).

Conditions

Interventions

DEVICE

All market approved CRT-D or ICD systems endowed with the APNEA Scan algorithm

Sponsors & Collaborators

  • Luigi Padeletti

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-09-30
Completion
2018-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02620930 on ClinicalTrials.gov