Post Approval Study of the remedē System

Respicardia

Status: Completed

Conditions: Central Sleep Apnea

Study type: Observational

Funder types: Industry

Identifiers

NCT03425188

CR1079

Details and patient eligibility

About

Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.

Full description

This Post Approval Study is a multi-center, prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System from the remedē System Pivotal Trial. Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible. An individual subject's participation is expected to continue to five years post remedē System implant.

Enrollment: 53 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who were previously implanted with the remedē System and participated in the remedē System Pivotal Trial
• In the investigator's opinion, willing and able to comply with all study requirements
• Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent (including Health Insurance Portability and Accountability Act [HIPAA] authorization in the US)

Exclusion criteria

• There are no criteria by which a subject would be excluded

Trial design

53 participants in 1 patient group

remedē System Subjects

Description:

Subjects who were implanted with the remedē System and actively followed as part of the remedē System Pivotal Trial at the time of study closure.