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The purpose of this prospective, non-randomized, single-arm, research study is to evaluate the accuracy of acutely extracting respiratory rate and tidal volume from implanted cardiac device impedance in subjects with heart failure.
In addition, to assess the feasibility of extracting respiratory rate from device EGM under various conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Pacing and Impedance Measurement system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Pacing and Impedance Measurement system | Device | Subjects indicated for Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy Defibrillator device implant will be requested to perform some respiratory manoeuvres while impedance and electrogram signals are recorded by the system |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of extracting respiratory features from intrathoracic impedance acutely in subjects with heart failure | Impedance-derived respiratory rate during different breathing patterns | Implant |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the feasibility of extracting respiratory rate from EGM under various conditions | EGM derived respiratory rate under various conditions. | Implant and 2 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rogier Receveur, Ir | Contact | +31-43-35-66-566 | rogier.receveur@medtronic.com | |
| Dafni Carmina, Ir | Contact | dafni.carmina@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Frederic Van Heuverswyn, MD | University Ghent | Principal Investigator |
| Ashley Chin, MD | Groote Schuur Hospital | Principal Investigator |
| Hielko Miljoen, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen | Recruiting | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| University Hospital, Antwerp |
| Principal Investigator |
| Universitair Ziekenhuis Gent | Recruiting | Ghent | 9000 | Belgium |
|
| Groote Schuur Hospital | Recruiting | Cape Town | 7925 | South Africa |
|