TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up (TRUST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00336284|
Recruitment Status : Completed
First Posted : June 13, 2006
Results First Posted : March 30, 2010
Last Update Posted : August 3, 2010
|Condition or disease||Intervention/treatment||Phase|
|Patient Indicated for an ICD||Other: Home Monitoring Other: In-Office Conventional Follow-up||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up|
|Study Start Date :||November 2005|
|Primary Completion Date :||June 2009|
|Study Completion Date :||June 2009|
Active Comparator: Home Monitoring
Home Monitoring programmed on.
Other: Home Monitoring
Home Monitoring programmed on. In-office and Home Monitoring evaluation at 3 and 15 months post ICD implant. Home Monitoring evaluation only at 6, 9, and 12 months post ICD implant.
In-Office Conventional Follow-up
Home Monitoring programmed off.
Other: In-Office Conventional Follow-up
Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.
- Home Monitoring Effectiveness [ Time Frame: 12 months ]Average number of office-based implantable cardioverter defibrillator (ICD) follow-up visits in the Home Monitoring arm vs the Conventional (calendar-based) follow-up arm.
- Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention. [ Time Frame: 12 months ]Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.
- Early Detection of Cardiac Events [ Time Frame: 12 months ]Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).
- Patient Initiated Follow-up [ Time Frame: 12 months ]Percentage of total patient initiated inqueries that result in ER or office follow-up visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336284
Show 110 Study Locations
|Principal Investigator:||Niraj Varma, MD, FRCP||The Cleveland Clinic|