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

Aortic Valve Stenosis Clinical Trial

— DISCOVER  

Official title:

A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System for the Treatment of Patients With Severe Aortic Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01845285
• Other study ID #: RP 001
• Status: Recruiting
• Phase: N/A
• First received: April 30, 2013
• Last updated: February 23, 2016
• Start date: March 2013
• Est. completion date: December 2019

Study information

• Verified date: February 2016
• Source: Direct Flow Medical, Inc.
• Contact: Christopher Naber, MD
• Phone: +49201897 0
• Email: c.naber[@]contilia.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2019
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 71 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Aortic Valve Replacement
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)

Locations

Country	Name	City	State
Germany	Elisabeth Krankenhaus	Essen
Italy	Ospedale Niguarda Ca' Granda	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Direct Flow Medical, Inc.

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from all-cause mortality at 30 days		30 days	Yes
Secondary	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)	30 days	Yes
Secondary	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)	30 days	Yes
Secondary	Clinical efficacy	All-cause mortality; All stroke (disabling and non-disabling); Hospitalization for valve-related symptoms or worsening congestive heart failure	30 days through 5 years	No
Secondary	Clinical efficacy	• NYHA Class III or IV	30 days through 5 years	No
Secondary	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)	30 days through 5 years	No
Secondary	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)	5 years	Yes
Secondary	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)	5 years	Yes

External Links

•   sponsor website