Viewing Study NCT02943512


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Study NCT ID: NCT02943512
Status: UNKNOWN
Last Update Posted: 2017-05-03
First Post: 2016-10-21
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Same Day Discharge
Sponsor: University of Cincinnati
Organization:

Study Overview

Official Title: Same Day Discharge
Status: UNKNOWN
Status Verified Date: 2017-05
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study is to assess if subjects receiving a clinically indicated implanted cardiac pacemaker or defibrillator can be safely discharge home the same day of the procedure.
Detailed Description: Subjects who are implanted with a clinically indicated implanted cardiac pacemaker or defibrillator will be randomized to standard of care (next day discharge) versus same day discharge post implant. Both groups will under go standard of care assessments prior to discharge. The same day discharge group will receive a phone call the next day to assess for events and will transmit device data electronically. Both groups will be seen 10 - 14 days after implant for further evaluation.

The subjects will also complete questionnaires regarding their knowledge of self care and satisfaction with care.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: