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Eligiblity Criteria SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - Eligiblity Criteria NCT01539746

- 27.09.21 - 1 Formular, 3 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Inclusion Criteria, Exclusion Criteria
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Baseline Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

Physical examination SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - Physical examination NCT01539746

- 12.02.16 - 1 Formular, 4 Itemgruppen, 25 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Physical Examination, 6-MWT, NYHA class
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Baseline - Visit 5 (30 days +15d) - Visit 6 (180 days +-30d) - Visit 7 (1 year + 1m) Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

CT Scan SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - CT Scan NCT01539746

- 06.02.16 - 1 Formular, 2 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, CT scan
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Baseline Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

Final Exam SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - Final Exam NCT01539746

- 04.02.16 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Study completion, Termination of study participation
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Completion of the study - Study termination/ Drop-out Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

Medication SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - Medication NCT01539746

- 04.02.16 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: Medication
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Visit 4 (7 days +1d) - Visit 5 (30 days +15d) - Visit 6 (180 day +-30d) - Visit 7 (1 year +1m) Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

Endpoints SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - Endpoints NCT01539746

- 04.02.16 - 1 Formular, 2 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Endpoints
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Visit 4 (7 days +1d) - Visit 5 (30 days +15d) - Visit 6 (180 day +-30d) - Visit 7 (1 year +1m) Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

Neurological assessment SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - Neurological assessment NCT01539746

- 03.02.16 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Neurological assessment
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Baseline - Visit 4 (7 days +1d) - Visit 5 (30 days +15d) - Visit 6 (180 day +-30d) - Visit 7 (1 year +1m) Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

Adverse Events SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - Adverse Events NCT01539746

- 03.02.16 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, AE
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Visit 1 (6h +-2h) - Visit 2 (24h +-8h) - Visit 3 (72h +-12h) - Visit 4 (7 days +1d) - Visit 5 (30 days +15d) - Visit 6 (180 day +-30d) - Visit 7 (1 year +1m) Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

Scores SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - Scores NCT01539746

- 03.02.16 - 1 Formular, 4 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Logist. EuroScore, STS mortality score, ASA classification
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Baseline Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

Laboratory Tests SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - Laboratory Tests NCT01539746

- 03.02.16 - 1 Formular, 2 Itemgruppen, 43 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Laboratory parameters
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Baseline - Visit 1 (6h +-2h) - Visit 2 (24h +-8h) - Visit 3 (72h +-12h) - Visit 4 (7 days +1d) - Visit 5 (30 days +15d) - Visit 6 (180 day +-30d) - Visit 7 (1 year +1m) Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

Pacemaker Check SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - Pacemaker Check NCT01539746

- 03.02.16 - 1 Formular, 2 Itemgruppen, 3 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Check of pacemaker
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Baseline - Visit 4 (7 days +1d) - Visit 5 (30 days +15d) - Visit 6 (180 day +-30d) - Visit 7 (1 year +1m) Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

Echocardiography SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - Echocardiography NCT01539746

- 02.02.16 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Transthoracal echocardiography
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Baseline - Visit 4 (7 days +1d) - Visit 5 (30 days +15d) - Visit 6 (180 day +-30d) - Visit 7 (1 year +1m) Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

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