Trial Outcomes & Findings for CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics (NCT NCT00619151)

Results Overview

Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

6 month evaluation

Results posted on

2011-11-16

Participant Flow

Participant milestones

Participant milestones
Measure	Top Hat Valve CarboMedics Supra-annular Top Hat Valve	St.Jude Valve St. Jude Medical Regent Valve
Overall Study STARTED	2	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Top Hat Valve CarboMedics Supra-annular Top Hat Valve	St.Jude Valve St. Jude Medical Regent Valve
Overall Study Study terminated prior to followup	1	0

Baseline Characteristics

CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Top Hat Valve n=2 Participants CarboMedics Supra-annular Top Hat Valve	St.Jude Valve St. Jude Medical Regent Valve	Total n=2 Participants Total of all reporting groups
Age, Customized <18 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Customized >= 18 years	2 participants n=5 Participants	—	2 participants n=5 Participants
Sex/Gender, Customized Unknown	2 participants n=5 Participants	—	2 participants n=5 Participants
Sex/Gender, Customized Female	NA participants n=5 Participants	—	—
Sex/Gender, Customized Male	NA participants n=5 Participants	—	—
Region of Enrollment United States	2 participants n=5 Participants	—	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 month evaluation

Population: Analysis not performed due to study termination prior to analysis period.

Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Analysis not performed due to study termination prior to analysis period.

Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.

Outcome measures

Outcome data not reported

Adverse Events

Top Hat Valve

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

St.Jude Valve

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Barbara Mathews Director Clinical and Medical Affairs

Sorin Group USA, Inc.

Phone: 512-435-3602

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60