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This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, physiological Diagnostic (PhD)which as been implemented in the PARADYM CRT Cardiac Resynchronization System with defibrillation capabalities (PARADYM CRT System,model 8770.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PhD | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paradym CRT 8770 | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of HF related events | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Co morbidities | 13 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Haines | Kaplan, Phoenix, | Arizona | United States | |||
| Drs. Lewis, Garg |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 10, 2017 | |
| Reset | Dec 7, 2017 |
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| Siegel, Phoenix, |
| Arizona |
| United States |
| Drs. Jagmeet Singh, Kevin, Hiest | Boston | Massachusetts | United States |
| Drs. John Fisher, Jay Gross | Montefiore, Bronx NY | New York | United States |
| Dr. Gold | Charleston | South Carolina | United States |
| Dr. Champagne, Dr. Philippon | Québec | Quebec | G1V 4G5 | Canada |
| Drs. Thibualt, Guerra | Québec | Quebec | H1T 1C8 | Canada |
| Dr. Dupuis | Angers | Angers | 49033 | France |
| Dr. Defaye | Grenoble | Grenoble | 38043 | France |
| Dr. Bru | La Rochelle | La Rochelle | 17019 | France |
| Pr. Kacet | Lille | Lille | 59037 | France |
| Dr. Pisapia | Marseille | Marseille | 13008 | France |
| Pr. Davy | Montpellier | Montpellier | 34000 | France |
| Dr. Burban | Nantes | Nantes | 44000 | France |
| Dr Abbey | Nantes | Nantes | 44093 | France |
| Dr. Ritter | Pessac | Pessac | 33604 | France |
| Pr. Mabo | Rennes | Rennes | 35033 | France |
| Pr. Anselme | Rouen | Rouen | 76031 | France |
| Pr. Da Costa | Saint-Etienne | Saint Etienne | 42055 | France |
| Dr. Delay | Toulouse | Toulouse | 31059 | France |
| Pr. Sadoul | Vandœuvre-lès-Nancy | Vandoeuvre Les Nancy | 54500 | France |
| Dr. Jauvert | Paris | 75016 | France |
| Dr. Sperzel | Bad Nauheim | Bad Nauheim | D-61231 | Germany |
| Dr. Vogt | Bad Oeynhausen | Bad Oeynhausen | D-32545 | Germany |
| Dr. Butter | Bernau | Bernau | 16321 | Germany |
| Pr. Brachmann | Coburg | Coburg | D-48149 | Germany |
| Dr. Klein - Dr. Oswald | Hanover | Hannover | 30625 | Germany |
| Pr. Bauer | Heidelberg | Heidelberg | 69120 | Germany |
| Pr. Mewis - Pr. Fröhlig | Homburg | Homburg | D-66421 | Germany |
| Dr. Wieckhorst | Kiel | Kiel | 24105 | Germany |
| Dr. Bonnemeier | Lübeck | Lübeck | D-23538 | Germany |
| Pr. Weiss | Lüneburg | Lüneburg | 21339 | Germany |
| Dr. Kolb | München | Munchen | 80636 | Germany |
| Pr. Eckhardt | Münster | Münster | D-48149 | Germany |
| Dr. Fleck - Dr. Goetze | Berlin | State of Berlin | 13353 | Germany |
| Dr. Schlegl | Berlin | State of Berlin | 14050 | Germany |
| Dr. Leonardo Calo | Roma | Roma | 00169 | Italy |
| Dr Mantovan | Treviso | Treviso | 31100 | Italy |
| Dr. Delnoy | Zwolle | Zwolle | 10500 | Netherlands |
| Dr. Martinez | Alicante | Alicante | 03010 | Spain |
| Dr. Brugada | Barcelona | Barcelona | 08036 | Spain |
| Dr. Peinado | Madrid | Madrid | 28046 | Spain |
| Dr. Beiras | Vigo | Vigo | 3204 | Spain |
| Dr Auricchio | Lugano | Lugano | CH-6900 | Switzerland |
| Dr. Leyva | Birmingham | Birmingham | B75 7RR | United Kingdom |
| Dr Fluck - Dr. Beeton | Chertsey | Chertsey | KT160PZ | United Kingdom |
| Dr. NG | Leicester | Leicester | LE3 9PQ | United Kingdom |
| Dr. Murgatroyd | London | London | WC2R 2LS | United Kingdom |
| Dr. Bowes | Sheffield | Sheffield | S5 7AU | United Kingdom |
| Dr. Morgan | Southampton | Southampton | SO16 9YD | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 10, 2017 | Dec 7, 2017 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004194 | Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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