Same Day Discharge

University of Cincinnati

Status: Unknown

Conditions: Cardiac Arrhythmia

Treatments: Other: Discharge day of procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02943512

2016-3696

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Discharge day of Procedure

Experimental group

Description:

Subjects in this arm will be discharged the same day of their cardiac device implant if deemed safe by treating physician.

Treatment:

Other: Discharge day of procedure

Control

No Intervention group

Description:

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.