Heart Failure Clinical Trial
Official title:
Phase IV Long Term Observational Study of Patients Implanted With Medtronic CRDM Implantable Cardiac Devices
Verified date | September 2017 |
Source | Medtronic Bakken Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To construct a computerized database of national profiles and epidemiological data on
patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with
or without cardiac resynchronization therapy), implantable loop recorders and leads used
within their intended use.
Clinical variables will be analyzed in relation to device-based data and diagnostics.
Status | Completed |
Enrollment | 8586 |
Est. completion date | March 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - (To be) implanted with a Medtronic market-released cardiac device, - Signed Patient Data Release Form. Exclusion Criteria: - Unwillingness or inability to cooperate or give voluntary consent |
Country | Name | City | State |
---|---|---|---|
Belgium | C.H.I.R.E.C. - Site de Braine la Alleud | Braine l'Alleud | |
Belgium | A.Z. Klina | Brasschaat | |
Belgium | St. Vincentius-Campus St. Jozef | Mortsel | |
Belgium | Centre de Medecine Cardiologique | Namur | |
Belgium | Centre Hosp. Régional du Tournaisis- Site Hopital | Tournai | |
Belgium | Hôpital Notre Dame de Tournai | Tournai | |
Former Serbia and Montenegro | Cardiovascular Institute Dedinje | Beograd (Belgrade) | |
Former Serbia and Montenegro | Clinical Centre Nis | Nis | |
Former Serbia and Montenegro | Instit. of Cardiovasc. Diseases, Univ. of Novi Sad | Sremska Kamenica | |
India | S.A.L. Hospital and Medical Institute | Ahmedabad | |
India | Max Devki Devi Foundation | New Delhi | |
Kuwait | Chest Disease Hospital | Safat | |
Russian Federation | Sverlovsk Regional Clinical Hospital N1 | Ekaterinburg | |
Russian Federation | Regional Clinical Cardio Center | Khabarovsk | |
Russian Federation | FGU Moscow SRC of Pediatrics & Childrens Surgery | Moscow | |
Russian Federation | Scientific Center of Heart Surgery by A.N. Bakulev | Moscow | |
Russian Federation | Scientific Research Institute of Transplantology | Moscow | |
Russian Federation | Novosibirsk Regional Cardio Center | Novosibirsk | |
Russian Federation | Scientific Research Institute of Circ. Pathology | Novosibirsk | |
Russian Federation | Rostov area hospital | Rostov-on-Don | |
Russian Federation | I.P. Pavlovs State Medical University- Hospital #2 | St. Petersburg | |
Russian Federation | Medical Academy of Postgraduate Studies | St. Petersburg | |
Russian Federation | Scientific Research Insitute of Cardiology | Tomsk | |
Russian Federation | Tyumen Cardiology Center | Tyumen | |
Russian Federation | Regional Hospital #1 | Vladivostok | |
Russian Federation | Volgograd cardio center | Volgograd | |
Saudi Arabia | Sweidan Raed King Fahd Armed Forces Hospital | Jeddah |
Lead Sponsor | Collaborator |
---|---|
Medtronic Bakken Research Center |
Belgium, Former Serbia and Montenegro, India, Kuwait, Russian Federation, Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic Cardiac Rhythm Management Devices | To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pulse generators [IPG] and implantable cardioverter defibrillators [ICD] both with or without cardiac resynchronization therapy [+/- CRT], implantable loop recorders [ILR] and leads implanted within intended use. Stratified per country, per pathology, per indication and per device type. |
2013 |
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