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Paradym CRT 8770

Phase 3

Heart Failure | Unknown | Cardiovascular |LivaNova PLC|Last Updated: Jun 19, 2014

Success Probability

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Market & Valuation

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Trial Design

NO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment520

FDA Designations

No designations recorded

Clinical trial landscape

Paradym CRT 8770 · 1 trial · 1 indication

Phase 3 1
NCT02167789Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT DeviceHeart Failure
COMPLETED520 Analytics
PHASE3COMPLETED
Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of HF related events
13 months

Secondary Endpoints

Co morbidities
13 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
PhDNO_INTERVENTION -

Interventions

NameTypeDescription
Paradym CRT 8770DEVICE -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: * Patient eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy * Severe HF (NYHA Class III or IV) at the time of enrollment * At least one HF-related event (as defined for primary objective) within the last 6...

Countries:United StatesCanadaFranceGermanyItalyNetherlandsSpainSwitzerlandUnited Kingdom
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Frequently asked questions about Paradym CRT 8770

What is Paradym CRT 8770 used for?

Paradym CRT 8770 is a cardiac resynchronization therapy device used for heart failure. It is currently in Phase 3 clinical development and is being studied in patients with heart failure. The device is designed to deliver cardiac resynchronization therapy to improve heart function in affected individuals.

Who makes Paradym CRT 8770?

Paradym CRT 8770 is developed by LivaNova PLC, a company publicly traded under the ticker LIVN. LivaNova is responsible for the clinical development and commercialization of this cardiac resynchronization therapy device for heart failure.

What phase is Paradym CRT 8770 in?

Paradym CRT 8770 is in Phase 3 clinical development. It is an investigational device and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the device is being evaluated for use in patients with heart failure.

What clinical trials is Paradym CRT 8770 in?

Paradym CRT 8770 has one completed Phase 3 clinical trial, identified as NCT02167789. This trial, titled 'Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device,' enrolled 520 participants with heart failure across multiple countries including the United States, Canada, and several European nations.

Is Paradym CRT 8770 FDA approved?

Paradym CRT 8770 is not FDA approved. It is an investigational device currently in Phase 3 clinical development. The completed Phase 3 trial (NCT02167789) evaluated the device in 520 patients with heart failure, but regulatory approval has not been granted.