Aortic Valve StenosisDISCOVERNCT01845285
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
An observational study of Aortic Valve Stenosis, run by Direct Flow Medical, Inc. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 71 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Aortic Valve Replacement
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2013to Dec 2019
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 71 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- The Direct Flow Medical device is contraindicated for post implant balloon valvuloplasty.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Elisabeth Krankenhaus
Essen, 45138
Christopher Naber, MD, +492018970, c.naber@contilia.de
Elisabeth Blank, RN, +49 201 8973218, e.blank@contilia.de
Italy1 site, 1 recruiting
- Recruiting
Ospedale Niguarda Ca' Granda
Milan, 20162
Federico DeMarco, MD, +390264442585, federico.demarco@gmail.com
Federico DeMarco, MD
About this study
Official title: A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System for the Treatment of Patients With Severe Aortic Stenosis
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.
Read the detailed description
The patient population will include patients who are candidates for transcatheter aortic valve replacement (TAVR). According to routine practice, the heart team (interventional cardiologist and cardiothoracic surgeon) makes a choice to use the Direct Flow Medical Aortic Valve System, compared to other available TAVR prostheses, on the basis of clinical and surgical considerations. Therefore, the valve is implanted when the heart team decides that this product is best suited to the specific patient.
In order to be enrolled in this Registry, the patient must be a candidate for the implantation of the Direct Flow Medical Transcatheter Aortic Valve System, based on the commercial indications as stated in the Instructions for Use.
Therefore, candidates for this study must meet the following criteria (Indications for Use):
- 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 AND
- 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.
All the Registry clinical evaluations and tests performed are generally considered standard of care for TAVR patients. When these recommendations conflict with the standard of care at the Registry site, the standard of care should prevail. In addition to the standard of care, the Sponsor recommends one brief additional evaluation (the EQ-5D quality of life measure) be conducted. Failure to perform this evaluation shall not be considered a protocol deviation.
Baseline Clinical Evaluation
- Medical History and Physical Exam
- 12 lead ECG and Arrhythmia Assessment
- Logistic EuroSCORE/STS Score
- New York Heart Association (NYHA) functional status
- Modified Rankin Score Assessment (mRS)
- Current Cardiac Medications Baseline Imaging Studies
- Transthoracic Echo (TTE)
- CT Scan (ECG triggered, contrast enhanced)
- Aorto-Iliac Angiogram:
- Peripheral Evaluation
- Coronary Evaluation
All patients will have clinical follow-up at hospital discharge, 30 days, 12 months and annually to 3 years and undergo the following evaluations:
- Physical Exam
- 12 lead ECG and Arrhythmia Assessment
- New York Heart Association (NYHA) functional status
- Modified Rankin Score Assessment (mRS) if symptomatic for stroke
- Current Cardiac Medications
- Transthoracic echo (TTE) Patients in whom the heart team has planned to use the Direct Flow Medical Transcatheter Aortic Valve System valve, are informed of the DISCOVER Registry and their consent to participate is required. This study intends to monitor the clinical condition of the patient for a period of 3 years after the operation. By agreeing to participate, the patient agrees to undergo clinical assessments and specific tests at certain intervals (prior to the procedure; during the implantation; at hospital discharge, at 30 days after the procedure, and at 1 year, 2 and 3 years later); the patient also agrees to the collection of these daThe purpose of this Registry is to monitor outcomes data for the Direct Flow Medical Transcatheter Aortic Valve System in the Post Market phase. The primary outcome of interest is freedom from all-cause mortality at 30 days. The results from the pivotal CE mark study (IP 010) yielded a 30 day freedom from all-cause mortality rate of 97%. Should the "true" rate be 97%, then N=250 patients would provide an estimate of the rate with a margin of error of 2%, with 95% confidence.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Aortic Valve Replacement
- Keywords
- transcatheter valve replacement, aortic valve disease, aortic stenosis, Aortic regurgitation,catheter, Effective orifice area
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic Valve ReplacementDevice
Also called Direct Flow Medical Percutaneous Aortic Valve 18F System, Discover, Transcatheter
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)
| Study group | Role | What they receive |
|---|---|---|
| aortic valve disease | aortic valve replacement Receives: Device: Aortic Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from all-cause mortality at 30 days
Measured: 30 days
Secondary outcomes (7)
Device Success (VARC defined)
- Absence of procedural mortality AND
- Correct positioning of a single prosthetic heart valve into the proper anatomic location AND
- Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20mmHg or peak velocity <3m/s, AND no moderate or severe prosthetic valve regurgitation)
Measured: 30 days
Early Safety
- All-cause mortality
- All stroke (disabling and non-disabling)
- Life-threatening bleeding
- Acute Kidney Injury - Stage 2 or 3 (including renal replacement therapy)
- Coronary artery obstruction requiring intervention
- Major vascular complications
- Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
Measured: 30 days
Clinical efficacy
- All-cause mortality
- All stroke (disabling and non-disabling)
- Hospitalization for valve-related symptoms or worsening congestive heart failure
Measured: 30 days through 5 years
Clinical efficacy
- NYHA Class III or IV
Measured: 30 days through 5 years
Clinical efficacy
- Prosthetic heart valve dysfunction (mean aortic valve gradient ≥20mm Hg, EOA ≤0.9-1.1cm2 [depending on body surface area] and/or DVI <0.35, AND/OR moderate or severe prosthetic valve regurgitation)
Measured: 30 days through 5 years
Time-related Valve Safety
- Structural valve deterioration:
- Valve-related dysfunction (mean aortic valve gradient (mean aortic valve gradient ≥20mmHg, EOA ≤0.9-1.1cm2 [depending on body surface area] and/or DVI <0.35, AND/OR moderate or severe prosthetic valve regurgitation)
- Requiring repeat procedure (TAVR or SAVR)
Measured: 5 years
Time-related Valve Safety
- Prosthetic valve endocarditis
- Prosthetic valve thrombosis
- Thromboembolic events (e.g., stroke)
- VARC bleeding, unless clearly unrelated to valve therapy (e.g., trauma)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Direct Flow Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Naber, MD, Principal investigator, Elisabeth Krankenhaus Essen GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845285
- Sponsor's protocol ID
- RP 001
- Acronym
- DISCOVER
- Status last verified
- Feb 2016
- First submitted
- 30 Apr 2013
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System for the Treatment of Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT01845285
- Acronym / sponsor ID
- DISCOVER / RP 001
- Conditions
- Aortic Valve Stenosis
- Keywords
- transcatheter valve replacement, aortic valve disease, aortic stenosis, Aortic regurgitation,catheter, Effective orifice area
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Direct Flow Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The patient population will include patients who are candidates for transcatheter aortic valve replacement (TAVR). According to routine practice, the heart team (interventional cardiologist and cardiothoracic surgeon) makes a choice to use the Direct Flow Medical Aortic Valve System, compared to other available TAVR prostheses, on the basis of clinical and surgical considerations. Therefore, the valve is implanted when the heart team decides that this product is best suited to the specific patient.
In order to be enrolled in this Registry, the patient must be a candidate for the implantation of the Direct Flow Medical Transcatheter Aortic Valve System, based on the commercial indications as stated in the Instructions for Use.
Therefore, candidates for this study must meet the following criteria (Indications for Use):
- 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 AND
- 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.
All the Registry clinical evaluations and tests performed are generally considered standard of care for TAVR patients. When these recommendations conflict with the standard of care at the Registry site, the standard of care should prevail. In addition to the standard of care, the Sponsor recommends one brief additional evaluation (the EQ-5D quality of life measure) be conducted. Failure to perform this evaluation shall not be considered a protocol deviation.
Baseline Clinical Evaluation
- Medical History and Physical Exam
- 12 lead ECG and Arrhythmia Assessment
- Logistic EuroSCORE/STS Score
- New York Heart Association (NYHA) functional status
- Modified Rankin Score Assessment (mRS)
- Current Cardiac Medications Baseline Imaging Studies
- Transthoracic Echo (TTE)
- CT Scan (ECG triggered, contrast enhanced)
- Aorto-Iliac Angiogram:
- Peripheral Evaluation
- Coronary Evaluation
All patients will have clinical follow-up at hospital discharge, 30 days, 12 months and annually to 3 years and undergo the following evaluations:
- Physical Exam
- 12 lead ECG and Arrhythmia Assessment
- New York Heart Association (NYHA) functional status
- Modified Rankin Score Assessment (mRS) if symptomatic for stroke
- Current Cardiac Medications
- Transthoracic echo (TTE) Patients in whom the heart team has planned to use the Direct Flow Medical Transcatheter Aortic Valve System valve, are informed of the DISCOVER Registry and their consent to participate is required. This study intends to monitor the clinical condition of the patient for a period of 3 years after the operation. By agreeing to participate, the patient agrees to undergo clinical assessments and specific tests at certain intervals (prior to the procedure; during the implantation; at hospital discharge, at 30 days after the procedure, and at 1 year, 2 and 3 years later); the patient also agrees to the collection of these daThe purpose of this Registry is to monitor outcomes data for the Direct Flow Medical Transcatheter Aortic Valve System in the Post Market phase. The primary outcome of interest is freedom from all-cause mortality at 30 days. The results from the pivotal CE mark study (IP 010) yielded a 30 day freedom from all-cause mortality rate of 97%. Should the "true" rate be 97%, then N=250 patients would provide an estimate of the rate with a margin of error of 2%, with 95% confidence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aortic valve disease | – | Device: Aortic Valve Replacementaortic valve replacement |
Who may qualify
- Ages
- 71 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (6 listed)
- Age > 70 years old
- Severe aortic valve stenosis determined by echocardiogram and Doppler:
- 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.
Key exclusion criteria (1 listed)
- The Direct Flow Medical device is contraindicated for post implant balloon valvuloplasty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortic Valve ReplacementAlso: Direct Flow Medical Percutaneous Aortic Valve 18F System, Discover, TranscatheterTransthoracic 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) | Device | aortic valve disease |
Primary outcome
Freedom from all-cause mortality at 30 days
Time frame: 30 days
7 secondary outcomes
Device Success (VARC defined)
Time frame: 30 days
Early Safety
Time frame: 30 days
Clinical efficacy
Time frame: 30 days through 5 years
Clinical efficacy
Time frame: 30 days through 5 years
Clinical efficacy
Time frame: 30 days through 5 years
Time-related Valve Safety
Time frame: 5 years
Time-related Valve Safety
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Naber, MD principal investigator
Elisabeth Krankenhaus Essen GmbH
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Direct Flow Medical, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Naber, MD (+49201897 0, c.naber@contilia.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from all-cause mortality at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.