NCT01845285

Brief Summary

The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial indications. Procedures and assessments required by this registry are generally considered standard of care for Transcatheter Aortic Valve Replacement patients. Evaluation criteria will be the incidence of mortality/morbidity and adverse events clinical performance, and hemodynamic performance of the DEVICE via ultrasound (echo) and angiographic imaging.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

3.8 years

First QC Date

April 30, 2013

Last Update Submit

February 23, 2016

Conditions

Aortic Valve Stenosis

Keywords

transcatheter valve replacementaortic valve diseaseaortic stenosisAortic regurgitation,catheterEffective orifice area

Outcome Measures

Primary Outcomes (1)

  • Freedom from all-cause mortality at 30 days

    30 days

Secondary Outcomes (7)

  • Device Success (VARC defined)

    30 days

  • Early Safety

    30 days

  • Clinical efficacy

    30 days through 5 years

  • Clinical efficacy

    30 days through 5 years

  • Clinical efficacy

    30 days through 5 years

  • +2 more secondary outcomes

Study Arms (1)

aortic valve disease

aortic valve replacement

Device: Aortic Valve Replacement

Interventions

Aortic Valve ReplacementDEVICE

Transthoracic Echo (TTE),CT Scan (ECG triggered, contrast enhanced),Aorto-Iliac Angiogram,Peripheral Evaluation,Coronary Evaluation,12 lead ECG,Arrhythmia Assessment, New York Heart Association (NYHA) functional status, Modified Rankin Score Assessment (mRS) if symptomatic for stroke, Current Cardiac Medications, Transthoracic echo (TTE)

Also known as: Direct Flow Medical Percutaneous Aortic Valve 18F System, Discover, Transcatheter
aortic valve disease

Eligibility Criteria

Age71 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Direct Flow Medical Transcatheter Aortic Valve System is intended for use in patients with severe aortic valve stenosis who require replacement of their native aortic valve but are extreme risk candidates for open surgical replacement. This is in accordance with the product Intended Use in the commercial Instructions for Use.

You may qualify if:

  • Age \> 70 years old
  • Severe aortic valve stenosis determined by echocardiogram and Doppler:
  • mean gradient \>40 mmHg or peak jet velocity \>4.0 m/s
  • aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2
  • Symptomatic aortic valve stenosis (angina, congestive heart failure, NYHA Functional Class ≥ II, or syncope).
  • Patient is an extreme risk candidate for open surgical aortic valve repair such that the site Investigators (interventional cardiologist and cardiothoracic surgeon) agree that medical factors preclude operation, based on the conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement due to the patient's co-morbidities (such as, but not limited to, severe COPD, porcelain aorta, previous thorax irradiation) or logistic EuroSCORE ≥ 20.

You may not qualify if:

  • The Direct Flow Medical device is contraindicated for post implant balloon valvuloplasty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Elisabeth Krankenhaus

Essen, 45138, Germany

RECRUITING

Ospedale Niguarda Ca' Granda

Milan, 20162, Italy

RECRUITING

Related Links

MeSH Terms

Conditions

Aortic Valve StenosisAortic Valve DiseaseAortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Christopher Naber, MD

    Elisabeth Krankenhaus Essen GmbH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Naber, MD

CONTACT

+49201897 0c.naber@contilia.de

Mary Edwards

CONTACT

7075760420medwards@directflowmedical.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 3, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2019

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

DE(1)IT(1)