Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01812174
Other study ID # 2010-01
Secondary ID G120115
Status Terminated
Phase N/A
First received
Last updated
Start date November 18, 2011
Est. completion date December 7, 2018

Study information

Verified date February 2024
Source On-X Life Technologies, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study examines the hemodynamic and hemolytic properties of two additional smaller size valves to the On-X line of valves already approved by FDA.


Description:

The purpose of the study is to assess the safety and efficacy of the 17mm On-X Aortic Prosthetic Heart Valve and the 23mm On-X Mitral Prosthetic Heart Valve when used to replace diseased aortic or mitral valves in human subjects. The On-X 17mm aortic valve will be implanted in approximately 20 and at least 15 patients who will be followed for at least 1 year. Patients will be any age and will require this size valve as determined in surgery but will be recruited prior to surgery based on results of preoperative screening tests. Enrollment into the 23mm mitral arm of the study has been terminated.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date December 7, 2018
Est. primary completion date December 7, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patients of any age; unless waived by local IRB assent of the patient and in all cases consent of parent or legally authorized representative is required if a patient is under the age of majority and not legally emancipated. 2. Patients who are sufficiently ill to warrant replacement of their diseased natural or prosthetic valve, based on standard cardiovascular diagnostic workups. 3. Patients who are in sufficient satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk, (i.e., likely to survive one year postoperatively). 4. Patients who require an isolated aortic valve replacement size 17 mm or isolated mitral valve replacement size 23mm. 5. Patients who are geographically stable and willing to return to the implanting center for follow-up visits. 6. Patients or legally authorized representatives who are adequately informed of their participation in the clinical study and what will be required of them in order to comply with the protocol. 7. Patients requiring concomitant cardiovascular surgery, such as coronary bypass may be included in the study. Exclusion Criteria: 1. Patients who are pregnant, planning to become pregnant or are lactating. 2 Patients who have a noncardiac progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient. 3 Patients who have a documented history of substance (drug or alcohol) abuse or are prison inmates. 4. Patients with a previous prosthetic valve, where it is not being replaced by a study valve, or patients requiring multiple valve replacement. 5. Patients with active endocarditis or active myocarditis. 6 Patients who require tricuspid or pulmonic valve replacement. 7. Patients who have not agreed to return for the required number of follow-up visits or who are geographically unavailable for follow-up. 8. Patients who cannot be maintained on long-term anticoagulant therapy. 9. Patients with non-cardiac illness resulting in a life expectancy of less than 1-year. 10. Patients previously enrolled and implanted in this trial may not re-enter after withdrawal. 11. Patients already enrolled in another investigational device or drug study (nor can enrolled patients be enrolled in other studies). 12. Patients with acute preoperative neurological deficit, myocardial infarction, or cardiac event who have not returned to baseline for at least 30-days prior to enrollment. 13. Patients with aortic aneurysm or other medical condition that creates a higher than usual risk of surgical complication. 14. Patients who are prisoners or mentally ill, and pediatric patients who are incapable of understanding their assent as judged by the principal investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
17mm aortic valve (On-X )
Heart aortic valve replacement surgery: 17mm Aortic
23mm mitral valve (On-X)
Heart mitral valve replacement surgery: 23mm Mitral

Locations

Country Name City State
Puerto Rico Mayaguez Medical Center Mayaguez
Spain Hospital Clinico Provincial Barcelona
Spain University Hospital Salamanca Salamanca
United States University of Virginia Charlottesville Virginia
United States Cincinnati Children's Medical Center Cincinnati Ohio
United States Children's Heart Center Nevada Las Vegas Nevada
United States Arkansas Children's Hospital Little Rock Arkansas
United States University of Oklahoma/Children's Hospital Oklahoma City Oklahoma
United States Maine Medical Center Portland Maine
United States Mary Bridge Children's - Tacoma General Hospital Tacoma Washington

Sponsors (1)

Lead Sponsor Collaborator
On-X Life Technologies, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Valve Related Adverse Events at 1 Year Number of subjects with a valve related adverse event at 1 year. 1 Year
Secondary Diagnosis of Valve Thrombosis at 1 Year Number of subjects with a diagnosis of Valve Thrombosis at 1 year 1-year
See also
  Status Clinical Trial Phase
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT02527629 - Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")
Completed NCT01178710 - Effect of Simvastatin on Cardiac Function N/A
Completed NCT01426776 - Effect of Heart Valve Replacement on Cheyne-Stokes Respiration N/A
Completed NCT00581399 - A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery Phase 2
Withdrawn NCT00187304 - ACTION - Anticoagulation Treatment Influence on Post-operative Patients Phase 4
Terminated NCT00700947 - Using Beta Blockers to Treat Mitral Regurgitation Phase 1
Recruiting NCT02574650 - Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™. N/A
Recruiting NCT02650388 - Frailty and Cognitive Function Assessment of TAVI Patients Phase 4
Completed NCT01996657 - D-dimer and Oral Anticoagulation Therapy in Patients With Mechanical Valve Replacement N/A
Terminated NCT00598936 - A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients Phase 1
Recruiting NCT03225612 - Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) N/A
Completed NCT01384643 - Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery Phase 4
Completed NCT01558765 - CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery Phase 2
Active, not recruiting NCT00291525 - Randomized On-X Anticoagulation Trial N/A
Completed NCT02867930 - Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography Phase 4
Recruiting NCT02478008 - A Clinical Study of the CardiAQ™ TMVI System (Transapical DS) N/A
Completed NCT02790008 - Magnetic Resonance Imaging and Fibrosis
Completed NCT02587039 - An Intervention to Reduce Delirium After Cardiac Surgery N/A
Recruiting NCT01855737 - The Study of Warfarin Maintenance Dose in Chinese Patients Phase 4