Heart FailureSDD for ICDNCT01993862
Same Day Discharge (SDD) After Implantable Cardioverter Defibrillator (ICD) Implant
A study testing Same Day Discharge in people with Heart Failure and Coronary Artery Disease, run by Abbott Medical Devices at 28 sites in United States.
Trial summary
The purpose of this study is to determine whether it is safe to send patients home from the hospital on the same day following an implantable cardioverter defibrillator (ICD) implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Coronary Artery Disease
- What is being tested?
- Same Day Discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 28 sitesUnited States
- Study dates
- 17 Mar 2014to 12 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has a St Jude Medical device that is compatible with Merlin.net (remote monitoring)
- Patient is receiving an implantable cardioverter defibrillator for primary prevention
- Patient lives within 50 miles of an emergency room or 24 hour urgent care
- Patient is able to sign informed consent
Who cannot join
- Patient experiences a complication during or 4 hours after implantable cardioverter defibrillator procedure
- Physician elects to keep the patient in over night due to a change in medical condition or a pre-existing condition that requires administration of continuous blood thinners
- Physician is unable to program the implantable cardioverter defibrillator to collect all required information remotely from device
- Patient is pregnant
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Exempla Rocky Mountain Cardiovascular Associates
Broomfield, Colorado, 80021
Cary Cardiology, PA
Cary, North Carolina, 27518
Chula Vista Cardiac Center
Chula Vista, California, 91910
The New York Hospital Queens
Flushing, New York, 11355
Cardiovascular Consultants Heart Center
Fresno, California, 93720
Heart Center Research
Huntsville, Alabama, 35801
Jackson Heart Clinic
Jackson, Mississippi, 39216
Cardiology Consultants
Johnson City, Tennessee, 37601
Lakeland Regional Medical Center
Lakeland, Florida, 33805
Watson Clinic Center
Lakeland, Florida, 33805
Thoracic Cardiovascular Healthcare Foundation
Lansing, Michigan, 48912
Florida Cardiovascular Specialists
Leesburg, Florida, 34748
South Denver Cardiology Associates PC
Littleton, Colorado, 80120
Loyola University Medical Center
Maywood, Illinois, 60153
Aurora Medical Group
Milwaukee, Wisconsin, 53215
Cardiology Associates of Mobile
Mobile, Alabama, 36608
Stanislaus Cardiology Group
Modesto, California, 95355
Naples Heart Rhythm Specialists, PA
Naples, Florida, 34102
Ochsner Medical Center
New Orleans, Louisiana, 70121
St. Luke's Hospital - Roosevelt
New York, New York, 10025
John C Lincoln North Mountain Hospital
Phoenix, Arizona, 85020
Great Lakes Heart and Cascular Institute PC
Saint Joseph, Michigan, 49085
Delmarva Heart
Salisbury, Maryland, 21804
Arrhythmia Associates of South Texas
San Antonio, Texas, 78217
Sutter Medical Center of Santa Rosa
Santa Rosa, California, 95404
Chicago Cardiology Institute
Schaumburg, Illinois, 60173
Missouri Baptist Medical Center
St Louis, Missouri, 63131
St. Louis Heart and Vascular PC
St Louis, Missouri, 63136
About this study
Official title: Safety and Cost Effectiveness of Same Day Discharge After Implantable Cardioverter-Defibrillator Implant Versus Next Day Discharge
The purpose of this study is to determine whether it is safe to send patients home from the hospital on the same day following an implantable cardioverter defibrillator (ICD) implant.
Read the detailed description
SDD for ICD is a prospective, randomized, multi-center study designed to show that SDD is safe in a defined patient population receiving an ICD implant and that this approach can be more cost effective for the hospital than the current NDD approach. Safety is to be demonstrated by showing that postoperative complications do not occur at a higher rate in the SDD group of patients when compared to the NDD group. Cost effectiveness is to be demonstrated by comparing health care utilization between the SDD and NDD groups for the first week post implantation. Patients who were implanted with a St. Jude Medical single or dual chamber ICD for primary prevention and who met all inclusion and exclusion criteria may be enrolled in the study. Patients areconsidered enrolled at the point of randomization.
Randomization is assigned in a 1:1 ratio between the NDD group and the SDD group. Patients will undergo study evaluations after implant, pre-discharge, 1-week and 6 months post implant.
- Conditions
- Heart Failure, Coronary Artery Disease
- Being tested
- Same Day Discharge
- Medical subject headings
- Heart Failure, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same Day DischargeOther
Patients will send device data remotely to their physician on the day of discharge from the hospital and again 24 hours after discharge from the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Next Day Discharge | No intervention | The patient will have a 23 hour standard of care observational stay in the hospital after an implantable cardioverter defibrillator implant procedure. |
| Same Day Discharge | Active comparator | The patient will be discharged from the hospital the same evening after an implantable cardioverter defibrillator implant procedure. Follow up after surgery will be done via remote device follow up (1) on the day of discharge and (2) 24 hours after surgery. Receives: Other: Same Day Discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate at 1 week after an implantable cardioverter defibrillator implant
Measured: 1 week
Secondary outcomes (2)
Cost savings per patient
Measured: 1 week
Complication rate at 6 months after an implantable cardioverter defibrillator implant
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study start17 Mar 2014
- Primary completion5 Aug 2016
- Study completion12 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Indrajit Choudhuri, MD, Principal investigator, University of Wisconsin, MadisonRanjit Suri, MD, Principal investigator, Heart Rhythm Associates of New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993862
- Sponsor's protocol ID
- 40009529/B
- Acronym
- SDD for ICD
- Status last verified
- Jan 2019
- First submitted
- 19 Nov 2013
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Cost Effectiveness of Same Day Discharge After Implantable Cardioverter-Defibrillator Implant Versus Next Day Discharge
- ClinicalTrials.gov ID
- NCT01993862
- Acronym / sponsor ID
- SDD for ICD / 40009529/B
- Conditions
- Heart Failure, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2014 (actual)
- Primary completion
- 5 Aug 2016 (actual)
- Study completion
- 12 Aug 2016 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether it is safe to send patients home from the hospital on the same day following an implantable cardioverter defibrillator (ICD) implant.
Detailed description
SDD for ICD is a prospective, randomized, multi-center study designed to show that SDD is safe in a defined patient population receiving an ICD implant and that this approach can be more cost effective for the hospital than the current NDD approach. Safety is to be demonstrated by showing that postoperative complications do not occur at a higher rate in the SDD group of patients when compared to the NDD group. Cost effectiveness is to be demonstrated by comparing health care utilization between the SDD and NDD groups for the first week post implantation. Patients who were implanted with a St. Jude Medical single or dual chamber ICD for primary prevention and who met all inclusion and exclusion criteria may be enrolled in the study. Patients areconsidered enrolled at the point of randomization.
Randomization is assigned in a 1:1 ratio between the NDD group and the SDD group. Patients will undergo study evaluations after implant, pre-discharge, 1-week and 6 months post implant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Next Day Discharge | No intervention | –The patient will have a 23 hour standard of care observational stay in the hospital after an implantable cardioverter defibrillator implant procedure. |
| Same Day Discharge | Active comparator | Other: Same Day DischargeThe patient will be discharged from the hospital the same evening after an implantable cardioverter defibrillator implant procedure. Follow up after surgery will be done via remote device follow up (1) on the day of discharge and (2) 24 hours after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has a St Jude Medical device that is compatible with Merlin.net (remote monitoring)
- Patient is receiving an implantable cardioverter defibrillator for primary prevention
- Patient lives within 50 miles of an emergency room or 24 hour urgent care
- Patient is able to sign informed consent
Key exclusion criteria (4 listed)
- Patient experiences a complication during or 4 hours after implantable cardioverter defibrillator procedure
- Physician elects to keep the patient in over night due to a change in medical condition or a pre-existing condition that requires administration of continuous blood thinners
- Physician is unable to program the implantable cardioverter defibrillator to collect all required information remotely from device
- Patient is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same Day DischargePatients will send device data remotely to their physician on the day of discharge from the hospital and again 24 hours after discharge from the hospital. | Other | Same Day Discharge |
Primary outcome
Complication rate at 1 week after an implantable cardioverter defibrillator implant
Time frame: 1 week
2 secondary outcomes
Cost savings per patient
Time frame: 1 week
Complication rate at 6 months after an implantable cardioverter defibrillator implant
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indrajit Choudhuri, MD principal investigator
University of Wisconsin, Madison
Ranjit Suri, MD principal investigator
Heart Rhythm Associates of New York, NY
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same Day Discharge in people with Heart Failure and Coronary Artery Disease, run by Abbott Medical Devices at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate at 1 week after an implantable cardioverter defibrillator implant (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.