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Paradym CRT+ Physiological Diagnosis · 1 trial · 1 indication
| 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...
Paradym CRT+ Physiological Diagnosis is a cardiac resynchronization therapy device used for congestive heart failure. It is designed to deliver CRT and includes a diagnostic feature to evaluate the patient's condition. The device is intended for patients with heart failure who may benefit from resynchronization therapy.
Paradym CRT+ Physiological Diagnosis is developed by LivaNova PLC, a company traded on the NASDAQ under the ticker LIVN. LivaNova is a medical technology company focused on cardiovascular and neuromodulation solutions. The device is part of their cardiac rhythm management portfolio.
Paradym CRT+ Physiological Diagnosis is in Phase 2 clinical development. It is an investigational device and has not been approved by the FDA. The Phase 2 trial has been completed, and the device is still in clinical development for the treatment of congestive heart failure.
Paradym CRT+ Physiological Diagnosis has one completed Phase 2 clinical trial with the identifier NCT00957541. The trial, titled 'Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device,' enrolled 520 participants in the United States. The study was double-blind and uncontrolled, and it included a biomarker selection component.
Paradym CRT+ Physiological Diagnosis is a cardiac resynchronization therapy device with an added diagnostic feature. It is designed to evaluate physiological parameters in patients with congestive heart failure. The device is distinct from standard CRT devices due to this diagnostic capability, which may help in patient management.