Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease

December 2, 2009 updated by: Ventor Technologies

Catheter-Based Transapical Implantation of the Ventor Embracer™ Heart Valve Prosthesis in Patients With Severe Aortic Valve Disease

A prospective single arm study evaluating feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with severe aortic valve disease, specifically aortic stenosis, who are at elevated risk for standard surgical valve replacement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Homburg, Germany, 66421
        • Prof. Jochen Schaefers
      • Koln, Germany, 50924
        • Prof. Thorsten Wahlers
      • Leipzig, Germany, 04289
        • Friedrich Mohr, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient understands the implications of participating in the study and provides informed consent
  2. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
  3. Age >75 years
  4. Severe, aortic stenosis (echocardiographically derived mean gradient > 40 mm Hg, and/or jet velocity > 4m/s, or an initial aortic valve area of < 0.8 cm2)
  5. Symptoms related to the aortic valve disease, as demonstrated by NYHA Functional Class II or greater
  6. EuroSCORE scale of >9 points indicating a predicted risk for mortality of >11% according to the logistic EuroSCORE
  7. Echocardiographically determined anteroposterior aortic annulus diameter of >19 and <23 mm
  8. Echocardiographically determined sinotubular junction diameter of ≥23 mm

Exclusion Criteria:

  1. Congenital unicuspid or bicuspid aortic valve
  2. Fused commissures
  3. Severe eccentricity of calcification
  4. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
  5. Severe left ventricular dysfunction (LVEF < 25%)
  6. More than mild right ventricular dysfunction
  7. Hypertrophic obstructive cardiomyopathy
  8. Moribund patients, or patients with a noncardiac disease limiting by itself life expectancy to less than 12 months
  9. Known hypersensitivity or contraindication to any study medication
  10. Known sensitivity to contrast medium that cannot be adequately controlled with pre-medication
  11. Known allergy or sensitivity to Nitinol
  12. Sepsis, or acute endocarditis
  13. Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy.
  14. Renal insufficiency and/or end stage renal disease requiring chronic dialysis
  15. Liver disease as indicated by jaundice, ascites, ALT/AST > 3 x ULN, elevation of total bilirubin > 1.5 mg/dl, albumin < 3.0 g/l, or INR > 1.5 (if not on anticoagulation).
  16. Significant lung disease (e.g. FEV1 < 1.2L or FEV1 < 50%).
  17. Active peptic ulcer or GI bleeding within 3 months from the planned index procedure
  18. Untreated clinically significant coronary artery disease requiring revascularisation
  19. Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance
  20. Peripheral vascular disease, including abdominal and thoracic aortic disease, which could pose a problem for eventual transarterial mechanical support (e.g. Intraaortic Balloon Pump)
  21. Need for emergency surgery, cardiac or noncardiac
  22. History of myocardial infarction in the last 6 weeks.
  23. History of TIA or stroke in the last 6 months.
  24. Any therapeutic invasive cardiac procedure, except aortic balloon valvuloplasty, performed within 30 days from the planned index procedure, or 6 months, in case of implantation of drug-eluting stents.
  25. Uncontrolled atrial fibrillation
  26. Pre-existing aortic valve replacement
  27. Severe (greater than 3+) mitral regurgitation
  28. Severe (greater than 3+) aortic regurgitation
  29. Patient is currently enrolled in another investigational device or drug trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Embracer implantation
Device: Ventor Embracer
Implantation of Ventor Embracer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Stable device placement and adequate function as assessed by angiography and echocardiography immediately post-procedure
Time Frame: day one
day one
A composite of any death, myocardial infarction, or disabling stroke at 30 days post-procedure
Time Frame: 30 days
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Device success and the absence of periprocedural MACCEs at post-operative day 1
Time Frame: day one
day one
Any of the following adverse events: death, myocardial infarction, disabling stroke, repeat aortic valve procedure, cardiogenic shock, or endocarditis at 30 days
Time Frame: 30 days
30 days
Any of the following adverse events: death, disabling stroke, repeat aortic valve procedure or endocarditis at 6 months
Time Frame: 6 months
6 months
Freedom from death at 1 year
Time Frame: 1 year
1 year
Functional improvement from baseline per New York Heart Association (NYHA) functional classification at 30 days, 6 months and 1 year
Time Frame: 1 year
1 year
Peak & mean pressure gradient, derived calculated measures of prosthetic valve function, aortic regurgitation - assessed by echocardiography immediately after deployment, at POD 1, 30 days, 6 months and 5 years annually
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ventor Technologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jochen Schaefers, MD, Universitatsklinikum des Saarlandes
  • Principal Investigator: Friedrich Mohr, MD, Universität Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLIN004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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