Recruiting

Observational Study

Sponsor:

University of Cincinnati

Code:

NCT02943512

Conditions

Cardiac Arrhythmia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Discharge day of procedure

Study Details

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.

Conditions

Cardiac Arrhythmia

Study ID

NCT02943512

Start date

Nov, 2016

Status verified date

May, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Nov, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Discharge day of procedure

Subjects will be discharged the day of the procedure if safe

Primary outcome measure

  • Average number of late complications between the 2 arms [ Time Frame: up to 2 weeks after procedure ]

Central Contacts and Locations

Central contacts

Locations

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

More Information

Sponsor

University of Cincinnati

Last update posted

May 3, 2017

Last verified

May, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2017-05-03.