Rationale and design of the CardioMEMS Post‐Market Multinational Clinical Study: COAST
Abstract Aims Chronic heart failure reduces quality and quantity of life and is expensive for healthcare systems. Medical treatment relies on guideline‐directed therapy, but clinical follow‐up and remote management is highly variable and poorly effective. New remote management strategies are needed...
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| Format: | Article |
| Language: | English |
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Wiley
2020-06-01
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| Series: | ESC Heart Failure |
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| Online Access: | https://doi.org/10.1002/ehf2.12646 |
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| author | Martin R. Cowie Pascal deGroote Scott McKenzie Marie‐Elena Brett Philip B. Adamson the CardioMEMS Post‐Market Study Investigators |
| author_facet | Martin R. Cowie Pascal deGroote Scott McKenzie Marie‐Elena Brett Philip B. Adamson the CardioMEMS Post‐Market Study Investigators |
| author_sort | Martin R. Cowie |
| collection | DOAJ |
| description | Abstract Aims Chronic heart failure reduces quality and quantity of life and is expensive for healthcare systems. Medical treatment relies on guideline‐directed therapy, but clinical follow‐up and remote management is highly variable and poorly effective. New remote management strategies are needed to maintain clinical stability and avoid hospitalizations for acute decompensation. Methods and results The CardioMEMS Post‐Market Study is a prospective, international, single‐arm, multicentre, open‐label study (NCT02954341) designed to examine the feasibility of haemodynamic guided heart failure management using a small pressure sensor permanently implanted in the pulmonary artery (PA). Daily uploaded PA pressures will be reviewed weekly to remotely guide medical management of patients with persistent NYHA Class III symptoms at baseline and a hospitalization in the prior 12 months. The study will enrol up to 800 patients from 85 sites across the United Kingdom, Europe, and Australia. The primary safety endpoint will assess device or system‐related complications or sensor failures after 2 years of follow‐up. Efficacy will be estimated after 1 year of follow‐up comparing HF hospitalization rates before and after sensor implantation. Observational endpoints will include mortality, patient, and investigator monitoring compliance, PA pressure changes, quality of life, and several pre‐defined subgroup analyses. Conclusions The CardioMEMS Post‐Market Study will investigate the generalizability of remote haemodynamic guided HF management in a number of national settings. The results may support the more widespread implementation of this novel clinical management approach. |
| format | Article |
| id | doaj-art-6856ff6008b344bb80c608626f91509c |
| institution | Kabale University |
| issn | 2055-5822 |
| language | English |
| publishDate | 2020-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | ESC Heart Failure |
| spelling | doaj-art-6856ff6008b344bb80c608626f91509c2025-02-03T10:25:46ZengWileyESC Heart Failure2055-58222020-06-017386587210.1002/ehf2.12646Rationale and design of the CardioMEMS Post‐Market Multinational Clinical Study: COASTMartin R. Cowie0Pascal deGroote1Scott McKenzie2Marie‐Elena Brett3Philip B. Adamson4the CardioMEMS Post‐Market Study InvestigatorsRoyal Brompton Hospital Imperial College London Sydney Street London SW3 6LY UKPôle Cardio‐Vasculaire et Pulmonaire, Hôpital Albert Calmette CHRU de Lille Boulevard du Pr. Jules Leclercq 59037 Lille CEDEX FranceThe Prince Charles Hospital and Holy Spirit Northside Hospital University of Queensland Rode Road Chermside QLD 4032 AustraliaHeart Failure Division Abbott 15900 Valley View Ct. Sylmar CA 91342 United StatesHeart Failure Division Abbott 15900 Valley View Ct. Sylmar CA 91342 United StatesAbstract Aims Chronic heart failure reduces quality and quantity of life and is expensive for healthcare systems. Medical treatment relies on guideline‐directed therapy, but clinical follow‐up and remote management is highly variable and poorly effective. New remote management strategies are needed to maintain clinical stability and avoid hospitalizations for acute decompensation. Methods and results The CardioMEMS Post‐Market Study is a prospective, international, single‐arm, multicentre, open‐label study (NCT02954341) designed to examine the feasibility of haemodynamic guided heart failure management using a small pressure sensor permanently implanted in the pulmonary artery (PA). Daily uploaded PA pressures will be reviewed weekly to remotely guide medical management of patients with persistent NYHA Class III symptoms at baseline and a hospitalization in the prior 12 months. The study will enrol up to 800 patients from 85 sites across the United Kingdom, Europe, and Australia. The primary safety endpoint will assess device or system‐related complications or sensor failures after 2 years of follow‐up. Efficacy will be estimated after 1 year of follow‐up comparing HF hospitalization rates before and after sensor implantation. Observational endpoints will include mortality, patient, and investigator monitoring compliance, PA pressure changes, quality of life, and several pre‐defined subgroup analyses. Conclusions The CardioMEMS Post‐Market Study will investigate the generalizability of remote haemodynamic guided HF management in a number of national settings. The results may support the more widespread implementation of this novel clinical management approach.https://doi.org/10.1002/ehf2.12646Clinical trialCardioMEMSTM HF SystemHaemodynamic monitoringHeart FailurePulmonary artery pressure |
| spellingShingle | Martin R. Cowie Pascal deGroote Scott McKenzie Marie‐Elena Brett Philip B. Adamson the CardioMEMS Post‐Market Study Investigators Rationale and design of the CardioMEMS Post‐Market Multinational Clinical Study: COAST ESC Heart Failure Clinical trial CardioMEMSTM HF System Haemodynamic monitoring Heart Failure Pulmonary artery pressure |
| title | Rationale and design of the CardioMEMS Post‐Market Multinational Clinical Study: COAST |
| title_full | Rationale and design of the CardioMEMS Post‐Market Multinational Clinical Study: COAST |
| title_fullStr | Rationale and design of the CardioMEMS Post‐Market Multinational Clinical Study: COAST |
| title_full_unstemmed | Rationale and design of the CardioMEMS Post‐Market Multinational Clinical Study: COAST |
| title_short | Rationale and design of the CardioMEMS Post‐Market Multinational Clinical Study: COAST |
| title_sort | rationale and design of the cardiomems post market multinational clinical study coast |
| topic | Clinical trial CardioMEMSTM HF System Haemodynamic monitoring Heart Failure Pulmonary artery pressure |
| url | https://doi.org/10.1002/ehf2.12646 |
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