Same Day Discharge

NCT ID: NCT02943512

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-12-31

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.

Conditions

Cardiac Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Discharge day of procedure

Intervention Type: OTHER

Subjects will be discharged the day of the procedure if safe

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Discharge day of procedure

Subjects will be discharged the day of the procedure if safe

Intervention Type: OTHER

Eligibility Criteria

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.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Alexandru Costea

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandru Costea, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexandru Costea, MD

Role: CONTACT

costeaai@ucmail.uc.edu

513-558-4272

Ginger Conway, MSN

Role: CONTACT

conwaygg@ucmail.uc.edu

513-558-3476

Facility Contacts

Alexandru Costea, MD

Role: primary

costeaai@ucmail.uc.edu

513-558-4272

Ginger Conway, MSN

Role: backup

conwaygg@ucmail.uc.edu

513-558-3476

Other Identifiers

2016-3696

Identifier Type: -

Identifier Source: org_study_id