Same Day Discharge

Not Applicable

• Conditions: Cardiac Arrhythmia
• Interventions: Other: Discharge day of procedure

• Registration Number: NCT02943512
• Lead Sponsor: University of Cincinnati

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 Timeline

• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Study Start: 2016-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-03
• Primary Completion: 2018-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Scheduled for clinically indicated implant of cardiac pacemaker or defibrillator

2. Willing and able to provide informed consent

3. Appropriate clinical indication for the purpose of this study

   1. Primary prevention implantable cardioverter-defibrillator implant indicated for sudden cardiac death with ejection fraction more than 20%
   2. Sick sinus syndrome, non-high degree heart block as indication for pacemaker implant.
   3. No history of syncope
   4. No documented sudden cardiac death or ventricular arrhythmias requiring shock

4. Adequate social support to be able to comply with protocol.

5. Ability to complete remote monitor transmission

Exclusion Criteria

1. Determined to be at risk for bleeding or on oral anticoagulation 2. Planned to be implanted with non-Biotronik device 3. Complete heart block as indication for permanent pacemaker 4. Secondary ICD indication 5. Immediate procedural complication requiring prolonged admission such as: pneumothorax, large hematoma, tamponade) determined during the procedure or immediately before discharge.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discharge day of Procedure	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.

Primary Outcome Measures

Name	Time	Method
Average number of late complications between the 2 arms	up to 2 weeks after procedure

Trial Locations

Locations (1)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States