Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Same Day Discharge | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate at 1 week after an implantable cardioverter defibrillator implant | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Cost savings per patient | 1 week | |
| Complication rate at 6 months after an implantable cardioverter defibrillator implant | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Indrajit Choudhuri, MD | University of Wisconsin, Madison | Principal Investigator |
| Ranjit Suri, MD | Heart Rhythm Associates of New York, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research | Huntsville | Alabama | 35801 | United States | ||
| Cardiology Associates of Mobile |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mobile |
| Alabama |
| 36608 |
| United States |
| John C Lincoln North Mountain Hospital | Phoenix | Arizona | 85020 | United States |
| Chula Vista Cardiac Center | Chula Vista | California | 91910 | United States |
| Cardiovascular Consultants Heart Center | Fresno | California | 93720 | United States |
| Stanislaus Cardiology Group | Modesto | California | 95355 | United States |
| Sutter Medical Center of Santa Rosa | Santa Rosa | California | 95404 | United States |
| Exempla Rocky Mountain Cardiovascular Associates | Broomfield | Colorado | 80021 | United States |
| South Denver Cardiology Associates PC | Littleton | Colorado | 80120 | United States |
| Lakeland Regional Medical Center | Lakeland | Florida | 33805 | United States |
| Watson Clinic Center | Lakeland | Florida | 33805 | United States |
| Florida Cardiovascular Specialists | Leesburg | Florida | 34748 | United States |
| Naples Heart Rhythm Specialists, PA | Naples | Florida | 34102 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Chicago Cardiology Institute | Schaumburg | Illinois | 60173 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Delmarva Heart | Salisbury | Maryland | 21804 | United States |
| Thoracic Cardiovascular Healthcare Foundation | Lansing | Michigan | 48912 | United States |
| Great Lakes Heart and Cascular Institute PC | Saint Joseph | Michigan | 49085 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| St. Louis Heart and Vascular PC | St Louis | Missouri | 63136 | United States |
| The New York Hospital Queens | Flushing | New York | 11355 | United States |
| St. Luke's Hospital - Roosevelt | New York | New York | 10025 | United States |
| Cary Cardiology, PA | Cary | North Carolina | 27518 | United States |
| Cardiology Consultants | Johnson City | Tennessee | 37601 | United States |
| Arrhythmia Associates of South Texas | San Antonio | Texas | 78217 | United States |
| Aurora Medical Group | Milwaukee | Wisconsin | 53215 | United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided