Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03425188
Study type Observational
Source Respicardia, Inc.
Contact
Status Completed
Phase
Start date June 28, 2018
Completion date August 4, 2020

See also
  Status Clinical Trial Phase
Completed NCT03032029 - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Completed NCT01426776 - Effect of Heart Valve Replacement on Cheyne-Stokes Respiration N/A
Recruiting NCT06043830 - Managing Opioid Related Sleep Apnea With Acetazolamide Phase 2
Completed NCT01831128 - French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS)
Withdrawn NCT02356367 - French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10CS): Predictive Factors of Poor Compliance (FACE) N/A
Completed NCT01124370 - Chronic Evaluation of Respicardia Therapy Phase 2
Completed NCT04907058 - Central Sleep Apnea Treated by CO2 Supplied by a Novel Device N/A
Recruiting NCT05949164 - The IPAd Study: Exploring the Association Between Insomnia and Positive Airway Pressure Adherence in Children
Completed NCT00922168 - Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients N/A
Completed NCT05354401 - Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents N/A
Recruiting NCT03621566 - Belgian Central Sleep Apnea REgistry
Completed NCT00551499 - Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF Phase 4
Recruiting NCT03884660 - remedē System Therapy Study
Terminated NCT03085641 - Treatment of Central Sleep Apnoea in Patients With Heart Failure With Nasal High Flow Therapy (nHFT) N/A
Completed NCT03226652 - Heart Function in Patients Assessed for Sleep Apnoea
Active, not recruiting NCT02116140 - ASV Effects on Myocardial Energetics and Sympathetic Nerve Function in Heart Failure and Sleep Apnea. N/A
Completed NCT03421704 - A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.
Recruiting NCT02919930 - Interface Selection for Adaptive Servo Ventilation N/A
Terminated NCT03919344 - Pathophysiological Study of CSA in Adults With pLVEF N/A
Completed NCT02034175 - Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing N/A