Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00957541 | Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device | PHASE2 | COMPLETED | 520 | — | — | Sep 1, 2009 | Apr 1, 2013 | May 15, 2014 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| CRT Therapy | EXPERIMENTAL | All patients will receive CRT therapy with the Physiological Diagnosis (PhD) feature enabled. |
| Name | Type | Description |
|---|---|---|
| Paradym CRT + Physiological Diagnosis (PhD) | DEVICE | All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled. |
Inclusion Criteria: * Subject eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy * Subject has severe heart failure (NYHA Class III or IV) * Subject has experienced at least one heart failure event within six months prior to e...