Trial Outcomes & Findings for Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves (NCT NCT02119442)
NCT ID: NCT02119442
Last Updated: 2019-04-30
Results Overview
The investigator will be assessing the efficacy of transcatheter heart valve (THV) by evaluating survival and development of infective endocarditis as an adverse event.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
8 years
Results posted on
2019-04-30
Participant Flow
Participant milestones
| Measure |
Transcatheter Valve Implantation
Intervention, Transcatheter Valve Implantation with Melody or Sapien bioprosthetic valve Standard of care intervention. All participants were considered to be under the same Arm/Group.
Transcather Valve Implantation: Transcather Valve Implantation
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Transcatheter Valve Implantation
n=90 Participants
Intervention, Transcatheter Valve Implantation with Melody or Sapien bioprosthetic valve Standard of care intervention.
Transcather Valve Implantation: Transcather Valve Implantation
|
|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=90 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=90 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=90 Participants
|
|
Age, Continuous
|
25 years
n=90 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=90 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=90 Participants
|
PRIMARY outcome
Timeframe: 8 yearsThe investigator will be assessing the efficacy of transcatheter heart valve (THV) by evaluating survival and development of infective endocarditis as an adverse event.
Outcome measures
| Measure |
Transcatheter Valve Implantation
n=90 Participants
Intervention, Transcatheter Valve Implantation with Melody or Sapien bioprosthetic valve Standard of care intervention.
Transcather Valve Implantation: Transcather Valve Implantation
|
|---|---|
|
Number of Participants Who Developed Infective Endocarditis
|
9 participants
|
Adverse Events
Transcatheter Valve Implantation
Serious events: 9 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Transcatheter Valve Implantation
n=90 participants at risk
Intervention, Transcatheter Valve Implantation with Melody or Sapien bioprosthetic valve Standard of care intervention.
Transcather Valve Implantation: Transcather Valve Implantation
|
|---|---|
|
Cardiac disorders
infective endocarditis
|
10.0%
9/90 • Number of events 15 • Adverse event data were collected until the latest follow up time point that the patients were seen by a physician. This time point included at least one year of follow up or more.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place