Same Day Discharge
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|ClinicalTrials.gov Identifier: NCT02943512|
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrhythmia||Other: Discharge day of procedure||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Same Day Discharge|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Discharge day of Procedure
Subjects in this arm will be discharged the same day of their cardiac device implant if deemed safe by treating physician.
Other: Discharge day of procedure
Subjects will be discharged the day of the procedure if safe
No Intervention: Control
Subjects in this arm will remain in the hospital overnight per standard of care and will be discharged the next day if deemed safe by treating physician.
- Average number of late complications between the 2 arms [ Time Frame: up to 2 weeks after procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943512
|Contact: Alexandru Costea, MDfirstname.lastname@example.org|
|Contact: Ginger Conway, MSNemail@example.com|
|United States, Ohio|
|University of Cincinnati Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45219|
|Contact: Alexandru Costea, MD 513-558-4272 firstname.lastname@example.org|
|Contact: Ginger Conway, MSN 513-558-3476 email@example.com|
|Principal Investigator:||Alexandru Costea, MD||University of Cincinnati|