Clinical trial NCT01845285: A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
Official title: A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System for the Treatment of Patients With Severe Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Keywords: transcatheter valve replacement
aortic valve disease
aortic stenosis
Aortic regurgitation,catheter
Effective orifice area
Lead sponsor: Direct Flow Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 71
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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):

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from all-cause mortality at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Device Success (VARC defined)
timeFrame: 30 days
measure: Early Safety
timeFrame: 30 days
measure: Clinical efficacy
timeFrame: 30 days through 5 years
measure: Clinical efficacy
timeFrame: 30 days through 5 years
measure: Clinical efficacy
timeFrame: 30 days through 5 years
measure: Time-related Valve Safety
timeFrame: 5 years
measure: Time-related Valve Safety
timeFrame: 5 years
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Elisabeth Krankenhaus
city: Milan
country: Italy
facility: Ospedale Niguarda Ca' Granda
Study officials:
affiliation: Elisabeth Krankenhaus Essen GmbH
name: Christopher Naber, MD
role: PRINCIPAL_INVESTIGATOR
References: