CClinicalTrials.gg
Status unknownNCT02943512Updated May 3, 2017

Same Day Discharge

An interventional study of Discharge day of procedure in Cardiac Arrhythmia, sponsored by University of Cincinnati. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-03.

Sponsored by University of Cincinnati · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cardiac Arrhythmia

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03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's planned enrollment of 40 is below the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study 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.

    Other: Discharge day of procedure

  • 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

  • OtherDischarge day of procedure

    Subjects will be discharged the day of the procedure if safe

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What researchers measure

Primary outcomes

  1. Average number of late complications between the 2 arms

    Time frame: up to 2 weeks after procedure

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Study locations

1 of 1 sites recruiting
  • University of Cincinnati Medical Center
    Cincinnati, Ohio 45219, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02943512
Lead sponsor
University of Cincinnati
Responsible party
Alexandru Costea (Principal Investigator, University of Cincinnati) — Principal investigator
First posted
Oct 24, 2016
Start date
Nov 2016
Primary completion
Nov 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
May 3, 2017

Study contacts

Alexandru Costea, MD
Contact
costeaai@ucmail.uc.edu
513-558-4272
Ginger Conway, MSN
Contact
conwaygg@ucmail.uc.edu
513-558-3476
Alexandru Costea, MD
principal investigator · University of Cincinnati

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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