A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
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.
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):

 1. Age > 70 years old

 2. 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

 3. Symptomatic aortic valve stenosis (angina, congestive heart failure, NYHA Functional
 Class ≥ II, or syncope).

 4. 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:

 1. Peripheral Evaluation

 2. 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.
Candidates for this study must meet all of the Indications criteria and none of the
 Contraindications.

 Inclusion Criteria (Indications):

 1. Age > 70 years old

 2. 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

 3. Symptomatic aortic valve stenosis (angina, congestive heart failure, NYHA Functional
 Class ≥ II, or syncope).

 4. 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.

 Exclusion Criteria (Contraindications):

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