TerminatedNCT01116037PASUpdated May 25, 2017Results posted

ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study

An interventional study of ATS 3f Aortic Bioprosthesis in Heart Valve Diseases, sponsored by Medtronic Cardiovascular. Terminated at 6 sites in 2 countries. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-25.

Sponsored by Medtronic Cardiovascular (part of Medtronic) · Not applicable, Interventional, and Treatment

Why this study was terminated

Business decision to end study due to limited enrollment and study population

Phase: Not applicable
Study type: Interventional
Enrollment: 26
Allocation: Not applicable
Ages: Up to 70 Years
Sex: All

Study summary

The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (\</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.

Read the detailed description

A multi-center non-randomized trial designed to obtain 606 patient years. Each enrolled patient will be followed for a minimum of six (6) years. Preoperative, discharge or 30 days (whichever comes last), 3-6 month, and annual follow-up data are required.

Conditions studied

Heart Valve Diseases

Browse trials for

Heart Valve Diseases 544

Keywords

Diseased Heart Valve, Replacement, Aortic, Stentless

In context

Heart Valve Diseases

544 studies on the registry are indexed under Heart Valve Diseases; 174 are open to participants now.

This study's enrollment of 26 is below the median of 100 across 296 interventional studies indexed under Heart Valve Diseases.

Browse Heart Valve Diseases studies →

Lead sponsor

Medtronic Cardiovascular is the lead sponsor of 70 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Browse Medtronic Cardiovascular studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patient is \</= 70 years of age and requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction. (The three remaining valves must be of native tissue).
Patient is sufficiently ill to warrant replacement of his/her diseased natural or prosthetic valve (excluding the ATS 3f Aortic Bioprosthesis, Model 1000 bioprosthesis), based on standard cardiovascular diagnostic workups.
Patient is in satisfactory condition, based on the physical exam and Investigator's experience, to be an average or better operative risk, (i.e., likely to survive three years postoperatively).
Patient is geographically stable and willing to return to the implant center for follow-up visits.
Patient has been adequately informed and consents to his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.

Exclusion criteria

Exclusion Criteria:

Patient is older than seventy (70) years of age.
Patient has a non-cardiac major or progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 3 years.
Patient is an intravenous drug and/or alcohol abuser.
Female patient is pregnant (urine HCG test result positive), or lactating.
Patient presents with active endocarditis.
Patient presents with congenital bicuspid aortic anatomy.
This patient presents with abnormal aortic root geometry.
Patient has chronic renal failure or is on renal dialysis.
Patient has a previously implanted prosthetic valve that is not being replaced by a study valve.
Patient requires mitral, tricuspid or pulmonic valve replacement.
Patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging.
Patient is participating in concomitant research studies of investigational products.
Patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 26 participants (actual)

Study arms

Other
ATS 3f Aortic Bioprosthesis
ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)
Device: ATS 3f Aortic Bioprosthesis

Interventions

DeviceATS 3f Aortic Bioprosthesis
Equine Pericardial Bioprosthesis for replacement of diseased valve

What researchers measure

Primary outcomes

Primary Efficacy Goal is to Assess the Freedom From Clinically Significant (Moderate or Greater) Aortic Regurgitation for the Patients Implanted With 3f Aortic Bioprothesis, Model 1000
Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval.
Time frame: Six Years

Secondary outcomes

Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.
Safety Analysis will be based on the the number of participants with cardiovascular complications.
Time frame: Six Years

Results

Posted May 25, 2017

Participant flow

Participant flow — Overall Study
Milestone	ATS 3f Aortic Bioprosthesis
Started	26
Completed	1
Not completed	25

Outcome measures

PrimaryPrimary Efficacy Goal is to Assess the Freedom From Clinically Significant (Moderate or Greater) Aortic Regurgitation for the Patients Implanted With 3f Aortic Bioprothesis, Model 1000

Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval.

Time frame:: Six Years
Reported as:: Count of participants · Participants

Primary Efficacy Goal is to Assess the Freedom From Clinically Significant (Moderate or Greater) Aortic Regurgitation for the Patients Implanted With 3f Aortic Bioprothesis, Model 1000
Participants	ATS 3f Aortic Bioprosthesis
Primary Efficacy Goal is to Assess the Freedom From Clinically Significant (Moderate or Greater) Aortic Regurgitation for the Patients Implanted With 3f Aortic Bioprothesis, Model 1000	1

SecondarySafety Analysis Will be Based on the Occurence of Cardiovascular Complications.

Safety Analysis will be based on the the number of participants with cardiovascular complications.

Time frame:: Six Years
Reported as:: Number · participants

Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.
participants	ATS 3f Aortic Bioprosthesis
Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.	11

Adverse events

Collected over 6 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ATS 3f Aortic Bioprosthesis	—	8/26 (30.8%)	3/26 (11.5%)

Most frequent serious events

Most frequent serious events
Event	ATS 3f Aortic Bioprosthesis
Cardiovascular ComplicationsCardiac disorders	8/26

Most frequent other events

Most frequent other events
Event	ATS 3f Aortic Bioprosthesis
Valve DysfunctionCardiac disorders	3/26
Vascular ComplicationVascular disorders	2/26

Baseline characteristics

Age, Continuous
Age, Continuous(years)	ATS 3f Aortic Bioprosthesis
Mean	60.8 ± 7.4

Sex: Female, Male
Sex: Female, Male(Participants)	ATS 3f Aortic Bioprosthesis
Female	10
Male	16

Region of Enrollment
Region of Enrollment(Participants)	ATS 3f Aortic Bioprosthesis
Canada	17
United States	9

Study locations

6 sites

Cardiac Surgery Clinical Research Center, Inc.
Oak Lawn, Illinois 60453, United States
Columbia University
New York, New York 10032, United States
Univ of Pennsylvania Medical Center
Philadelphia, Pennsylvania 19104, United States
Main Line Health Heart Center
Wynnewood, Pennsylvania 19096, United States
Baylor University
Dallas, Texas 75226, United States
McGill University Health Center
Montreal, Quebec H3A 1A1, Canada

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01116037
Lead sponsor: Medtronic Cardiovascular
Responsible party: Sponsor
First posted: May 4, 2010
Start date: Sep 2009
Primary completion: Nov 2015
Completion: Nov 2015
Results posted: May 25, 2017
Last update: May 25, 2017

Study contacts

Ryan Palmer

study director · Medtronic

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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