Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure NYHA Class III | Device: Cordella™ Pulmonary Artery Sensor System | Not Applicable |
The study objectives are:
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Prospective, Multi-Center, Open-Label, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients (SIRONA 2 Trial) |
Actual Study Start Date : | June 26, 2019 |
Estimated Primary Completion Date : | November 2021 |
Estimated Study Completion Date : | December 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Cordella™ Pulmonary Artery Sensor System
The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management
|
Device: Cordella™ Pulmonary Artery Sensor System
The Cordella PA Sensor System comprises seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation.
|
Change in PA pressure:
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
HF related hospitalization, HF treatment in a hospital day-care setting, or unplanned outpatient clinic HF visit within 12 months prior to consent and/or increase of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) at time of Screening defined as:
Exclusion Criteria:
Contact: Sladjana Nincic | +49 160 979 24095 | sladjana.nincic@endotronix.com |
Belgium | |
Cardivascular Center OLV Aalst | Recruiting |
Aalst, Belgium | |
Contact: Dr. Jozef Bartunek | |
Ziekenhuis- Oost Limburg | Recruiting |
Genk, Belgium | |
Contact: Prof. Wilfried Mullens | |
Germany | |
Uniklinik Köln, Klinik III für Innere Medizin Herzzentrum der Universität zu Köln | Recruiting |
Cologne, Germany | |
Contact: Prof. Stephan Rosenkranz | |
Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen Medizinische Klinik I, Abteilung Kardiologie und Angiologie | Recruiting |
Gießen, Germany, 35392 | |
Contact: Prof. Birgit Assmus | |
Klinik für Kardiologie und Angiologie/ Studienambulanz Medizinische Hochschule Hannover (MHH) | Recruiting |
Hannover, Germany, 30625 | |
Contact: Prof. Tibor Kempf | |
Ireland | |
Mater Misericordiae University Hospital | Recruiting |
Dublin, Ireland | |
Contact: Prof. Niall Mahon | |
University Hospital Galway | Recruiting |
Dublin, Ireland | |
Contact: Dr. Faisal Sharif |
Study Director: | Andrea Sauerland | Endotronix, Inc. |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | June 12, 2019 | ||||
First Posted Date ICMJE | July 9, 2019 | ||||
Last Update Posted Date | February 4, 2021 | ||||
Actual Study Start Date ICMJE | June 26, 2019 | ||||
Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | SIRONA 2 Trial Heart Failure NYHA Class III | ||||
Official Title ICMJE | A Prospective, Multi-Center, Open-Label, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients (SIRONA 2 Trial) | ||||
Brief Summary | This is a prospective, multi-center, open-label, single-arm CE-Mark trial to assess device safety and efficacy of the Cordella PA Sensor System in 60 New York Heart Association (NYHA) Class III Heart Failure patients who will receive the Cordella PA Sensor Implant. | ||||
Detailed Description |
The study objectives are:
|
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||
Condition ICMJE | Heart Failure NYHA Class III | ||||
Intervention ICMJE | Device: Cordella™ Pulmonary Artery Sensor System
The Cordella PA Sensor System comprises seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation.
|
||||
Study Arms ICMJE | Experimental: Cordella™ Pulmonary Artery Sensor System
The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management
Intervention: Device: Cordella™ Pulmonary Artery Sensor System
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2023 | ||||
Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
|
||||
Listed Location Countries ICMJE | Belgium, Germany, Ireland | ||||
Removed Location Countries | United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT04012944 | ||||
Other Study ID Numbers ICMJE | ETX-HFS-PA-02 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Endotronix, Inc. | ||||
Study Sponsor ICMJE | Endotronix, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | Endotronix, Inc. | ||||
Verification Date | February 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |