remedē System Therapy Study

Active, not recruiting

• Conditions: Central Sleep Apnea

• Registration Number: NCT03884660
• Lead Sponsor: Respicardia, Inc.

Brief Summary

The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.

Detailed Description

This is a multi-center, prospective, open label, non-randomized study to collect safety and effectiveness data in subjects with central sleep apnea implanted with the remedē System. Approximately 225 subjects will be enrolled and implanted at approximately 50 sites in the United States and Europe. A sub-study involving the WatchPAT device will be performed in a subset of sites.

Study Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-21
• Study Start: 2019-06-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-06-30
• Study Completion: 2030-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate safety of the remedē System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy	5 years	Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remedē System implant procedure, device or delivered therapy
Evaluate changes in sleep disordered breathing metrics after 12 months of therapy	12 months	Change from baseline to 12-month visit for the following sleep metrics measured during in-lab polysomnogram (PSG): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4) and percent of sleep with oxygen saturation \<90%

Secondary Outcome Measures

Name	Time	Method
Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy	5 years	Proportion of subjects with non-serious AEs related to the remedē System implant procedure, device or delivered therapy
Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy	36 and 60 months	Change from baseline to 36- and 60-month visits for the following sleep metrics during an at home sleep apnea test (HSAT): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4), percent of sleep with oxygen saturation \<90%

Trial Locations

Locations (32)

Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States

Arizona Heart Rhythm Center; 🇺🇸 Phoenix, Arizona, United States

HonorHealth; 🇺🇸 Scottsdale, Arizona, United States

The University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado- Anschutz; 🇺🇸 Aurora, Colorado, United States

University of Colorado Health; 🇺🇸 Fort Collins, Colorado, United States

Central Florida Pulmonary Group; 🇺🇸 Orlando, Florida, United States

Emory University Midtown Hospital; 🇺🇸 Atlanta, Georgia, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Baptist Health Lexington; 🇺🇸 Lexington, Kentucky, United States

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