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
Not provided
Although shock therapy is effective in terminating ventricular tachycardia (VT), it can be painful to the patient and repetitive shocks can decrease a patient's quality of life. Previous studies have suggested that one or more sets of aggressive device parameter settings may reduce the total number of shocks in primary prevention patients. In addition to shock therapies, antitachycardia pacing (ATP) is also available in ICDs to treat VT. The PROVIDE trial aims to prospectively study the effect of high detection rates, prolonged detection intervals, aggressive SVT discriminators, and extensive ATP therapy in prolonging the time to first shock in primary prevention patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | PROVE Trial settings |
| |
| Experimental | Pre-selected settings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD/ CRT-D | Device | Cardiac device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of this study is the rate of first shock | Average follow-up period is 530 days | |
| The primary safety endpoint of this study is the rate of arrhythmic syncope | Average follow-up period is 530 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with approved ICD/CRT-D indications
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mohammad Saeed, MD | Hall-Garcia Cardiology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hall-Garcia Cardiology Associates | Houston | Texas | 77598 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24112717 | Result | Saeed M, Hanna I, Robotis D, Styperek R, Polosajian L, Khan A, Alonso J, Nabutovsky Y, Neason C. Programming implantable cardioverter-defibrillators in patients with primary prevention indication to prolong time to first shock: results from the PROVIDE study. J Cardiovasc Electrophysiol. 2014 Jan;25(1):52-9. doi: 10.1111/jce.12273. Epub 2013 Sep 24. | |
| 29749945 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012769 | Shock |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
| Sanders P, Connolly AT, Nabutovsky Y, Fischer A, Saeed M. Increased Hospitalizations and Overall Healthcare Utilization in Patients Receiving Implantable Cardioverter-Defibrillator Shocks Compared With Antitachycardia Pacing. JACC Clin Electrophysiol. 2018 Feb;4(2):243-253. doi: 10.1016/j.jacep.2017.09.004. Epub 2017 Nov 15. |
| D004567 |
| Electrodes, Implanted |
| D019736 | Prostheses and Implants |