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Congestive Heart Failure

Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar

Sponsored by Biotronik, Inc.

About this trial

Last updated 6 years ago

Study ID

CELESTIAL

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 7 years ago

What is this trial about?

The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.

What are the participation requirements?

Yes

Inclusion Criteria

- Successfully implanted BIOTRONIK CRT system, including a Corox BP LV lead, from 7-180 days prior to enrollment

- Able to understand the nature of the registry and give informed consent

- Available for follow-up visits on a regular basis at the investigational site

- Age greater than or equal to 18 years

No

Exclusion Criteria

- Enrolled in any IDE clinical study

- Planned cardiac surgical procedures or interventional measures within the next 6 months

- Expected to receive a heart transplant within 1 year

- Life expectancy less than 1 year

- Presence of another life-threatening, underlying illness separate from their cardiac disorder

- Pregnancy

- Inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant

Locations

Location

Status