Study: NCT00291525

Adverse event: Paravaluvular Leak
Serious: yes
Organ System: Cardiac disorders
Notes: "Any evidence of leakage of blood around the prosthesis between the sewing ring and native annulus" (Protocol, Section C, page 21
Frequency: 1 affected / 99 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Notes: Documented evidence of infection of the prosthesis \[Protocol, Section C, page 20\]
Frequency: 1 affected / 99 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Whether considered valve-related or not
Frequency: 1 affected / 99 at risk

Adverse event: Other - Cardiovascular and Pulmonary
Serious: yes
Organ System: Cardiac disorders
Notes: Complication or any new diagnosis that is not related to the prosthesis, but is important to subsequent morbidity and mortality of the patient (Protocol, Section C, Page 22)
Frequency: 10 affected / 99 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Whether considered valve-related or not
Frequency: 1 affected / 102 at risk

Adverse event: Other - Cardiovascular and Pulmonary
Serious: yes
Organ System: Cardiac disorders
Notes: Complication or any new diagnosis that is not related to the prosthesis, but is important to subsequent morbidity and mortality of the patient (Protocol, Section C, Page 22)
Frequency: 12 affected / 102 at risk

Adverse event: Paravaluvular Leak
Serious: yes
Organ System: Cardiac disorders
Notes: "Any evidence of leakage of blood around the prosthesis between the sewing ring and native annulus" (Protocol, Section C, page 21
Frequency: 3 affected / 185 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Notes: Documented evidence of infection of the prosthesis \[Protocol, Section C, page 20\]
Frequency: 4 affected / 185 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Whether considered valve-related or not
Frequency: 4 affected / 185 at risk

Adverse event: Other - Cardiovascular and Pulmonary
Serious: yes
Organ System: Cardiac disorders
Notes: Complication or any new diagnosis that is not related to the prosthesis, but is important to subsequent morbidity and mortality of the patient (Protocol, Section C, Page 22)
Frequency: 27 affected / 185 at risk

Adverse event: Paravaluvular Leak
Serious: yes
Organ System: Cardiac disorders
Notes: "Any evidence of leakage of blood around the prosthesis between the sewing ring and native annulus" (Protocol, Section C, page 21
Frequency: 6 affected / 190 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Notes: Documented evidence of infection of the prosthesis \[Protocol, Section C, page 20\]
Frequency: 2 affected / 190 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Whether considered valve-related or not
Frequency: 10 affected / 190 at risk

Adverse event: Other - Cardiovascular and Pulmonary
Serious: yes
Organ System: Cardiac disorders
Notes: Complication or any new diagnosis that is not related to the prosthesis, but is important to subsequent morbidity and mortality of the patient (Protocol, Section C, Page 22)
Frequency: 25 affected / 190 at risk

Adverse event: Paravaluvular Leak
Serious: yes
Organ System: Cardiac disorders
Notes: "Any evidence of leakage of blood around the prosthesis between the sewing ring and native annulus" (Protocol, Section C, page 21
Frequency: 5 affected / 201 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Notes: Documented evidence of infection of the prosthesis \[Protocol, Section C, page 20\]
Frequency: 3 affected / 201 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Whether considered valve-related or not
Frequency: 31 affected / 201 at risk

Adverse event: Other - Cardiovascular and Pulmonary
Serious: yes
Organ System: Cardiac disorders
Notes: Complication or any new diagnosis that is not related to the prosthesis, but is important to subsequent morbidity and mortality of the patient (Protocol, Section C, Page 22)
Frequency: 55 affected / 201 at risk

Adverse event: Paravaluvular Leak
Serious: yes
Organ System: Cardiac disorders
Notes: "Any evidence of leakage of blood around the prosthesis between the sewing ring and native annulus" (Protocol, Section C, page 21
Frequency: 1 affected / 200 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Notes: Documented evidence of infection of the prosthesis \[Protocol, Section C, page 20\]
Frequency: 10 affected / 200 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Whether considered valve-related or not
Frequency: 33 affected / 200 at risk

Adverse event: Other - Cardiovascular and Pulmonary
Serious: yes
Organ System: Cardiac disorders
Notes: Complication or any new diagnosis that is not related to the prosthesis, but is important to subsequent morbidity and mortality of the patient (Protocol, Section C, Page 22)
Frequency: 45 affected / 200 at risk