Unique ID issued by UMIN | UMIN000021427 |
---|---|
Receipt number | R000024400 |
Scientific Title | Single center, Exploratory Safety Evaluation Study of Transcatheter Closure of Prosthetic Paravalvular Regurgitation |
Date of disclosure of the study information | 2016/03/11 |
Last modified on | 2019/03/25 20:55:48 |
Single center, Exploratory Safety Evaluation Study
of Transcatheter Closure of Prosthetic Paravalvular Regurgitation
Exploratory Evaluation Study
of Transcatheter Closure of Prosthetic Paravalvular Regurgitation (STOP PARA study)
Single center, Exploratory Safety Evaluation Study
of Transcatheter Closure of Prosthetic Paravalvular Regurgitation
Exploratory Evaluation Study
of Transcatheter Closure of Prosthetic Paravalvular Regurgitation (STOP PARA study)
Japan |
Prosthetic paravalvular regurgitation after heart valve replacement
Cardiology | Cardiovascular surgery |
Others
NO
Prosthetic paravalvular regurgitation indicates the condition of the regurgitation through the adjacent position of prosthetic valve without prosthetic valve failure itself. Paravalvular regurgitation occurs in 2-10% of surgical prostheses of aortic valve and 7-17% of patients of those of
mitral valve. Most of patients with paravalvular prosthetic regurgitation do not have symptoms, but 1-5% of them have symptoms of severe heart failure or haemolytic anemia, and 1-3% of patients with paravalvular leak require reoperations due to symptomatic paravalvular leak. Conservative treatment for the clinically-severe regurgitation results in 10-year survival rates of about 30%. For those patients, the treatment of paravalvular prosthetic regurgitation traditionally has been repeat open surgery, which may be challenging because of technical factors and can be associated with high
operative risk and variable results. Actually, the mortality of repeated open surgery for paravalvular regurgitation is as high as 6-42% (13%, 15% and 37% after the first, second and third or subsequent
reoperation, respectively). Additionally, the incidence of stroke during the perioperative period, wound infection on sternotomy, infective endocarditis, and re-paravalvular regurtitation are 5.1%,
25%, 7.5%, and 20-37%, respectively. Overall, 10-year survival rates after the repeated open surgery are 63%.
Recently, percutaneous approaches to treatment of paravalvular prosthetic regurgitation have been developed and can be performed with a relatively high rate of procedural success and an acceptable incidence of complications. Overall,the 30-day complication rate was 8.7%
This study seeks to evaluate the safety of transcatheter closure of prosthetic paravalvular regurgitation for patients with heart failure and/or hemolytic anemia caused by prosthetic paravalvular regurgitation after heart valve replacement in a hospital specializing in heart diseases in Japan.
Safety
Exploratory
Pragmatic
1. Major complication and failure during the procedure
Death, stroke, myocardial infarction, cardiac perforation, cardiac tamponade, cardiogenic shock, prosthetic valve failure, major bleeding, injury of great vessels caused by the procedure, embolism of organs, and embolism and/or malposition of the device.
2. Success rate and efficacy of the procedure
Acute procedural success was defined as successful deployment of one and more occluder devices that resulted in significant reduction in paravalvular regurgitation to mild or less-residual
regurgitation.
1. Assessment of the effectiveness
The effectiveness of the procedure is evaluated by the following items, which are compared with those before the procedure:
(1) Paravalvular regurgitation evaluated by transthoracic echocardiography at day 7 and 30 after the procedure.
(2) Paravalvular regurgitation evaluated by transesophageal echocardiography at day 7 and 30 after the procedure.
(3) NYHA class at day 7 and 30 after the procedure.
(4) 6-minute walk distance at day 7 after the procedure.
(5) Left ventricular diastolic diameters at day 7 and 30 after the procedure.
(6) Left ventricular ejection fraction at day 7 and 30 after the procedure.
(7) Plasma BNP levels at day 7 and 30 after the procedure, compared with those before the procedure.
(8) Pulmonary capillary wedge pressure immdediately after the procedure.
(9) Cardiac index immdediately after the procedure.
2. Assessment of the safety
The safety of the procedure is evaluated by the following items:
(1) Overall death in 30 days after the procedure
(2) Exacerbation of heart failure in 30 days after the procedure
(3) Exacerbation of hemolytic anemia in 30 days after the procedure
(4) Major complication and failure in 30 days after the procedure, including death from any causes, stroke, myocardial infarction, acute renal failure, cardiac perforation, cardiac tamponade, cardiogenic shock, prosthetic valve failure, valve endocarditis, major bleeding, injury of great vessels caused by the procedure, embolism of organs, and embolism and/or malposition of the device.
(5) Major adverse events in 30 days after the procedure
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
The occlusion device (Amplatzer Vascular Plug II, St. Jude Medical, Inc. MN, USA) will be implanted via percutaneous approach. The size and number of the device will be scheduled using transesophageal echocardiography and CT perfomed before the procedure. Actual size and number of the device will be
finally determined during the procedure, evaluating the residual paravalvular regurgitation after the implantation of each device with transesophageal echocardiography.
20 | years-old | <= |
Not applicable |
Male and Female
The candidates of this study are those who are not eligible to undergo elective open-chest surgery for the repair of the paravalvular leak because of the high risk of the operation, although heart failure and/or hemolytic anemia caused by the paravalvular leak are resistant to medical therapy.
Patients will be considered for percutaneous repair if the following criteria were met:
(1) Age of 20 years old and above when got informed concent.
(2) More than mild paravalvular prosthetic regurgitation.
(3) Heart failure or hemolysis anemia which are resistant to medical treatments.
(4) High surgical risk by STS scores or the consensus between a local independent cardiologist and a cardiac surgeon that conventional surgery would be associated with excessive morbidity and mortality.
Patients will not be considered for percutaneous repair if the following criteria were met:
(1) Patients with metal allergy
(2) Patients with allergy to contrast agent
(3) Echocardiographic evidence of intra-cardiac mass, thrombus, or vegetation
(4) Patients in shock
(5) Patients who are or are posslibly, or are lactating
(6) Patients who are participating, or going to participate in other clinical studies.
(7) Patients judged inappropriate for the study by the principal
5
1st name | Junjiro |
Middle name | |
Last name | Kobayashi |
National Cerebral and Cardiovascular Center
Cardiovascular Surgery
5658565
5-7-1, Fujishiro-dai, Suita, Osaka, JAPAN
81-6-6833-5012
hasegawa@ncvc.go.jp
1st name | Takuya |
Middle name | |
Last name | Hasegawa |
National Cerebral and Cardiovascular Center
Cardiovascular Medicine
5658565
5-7-1, Fujishiro-dai, Suita, Osaka, JAPAN
81-6-6833-5012
hasegawa@ncvc.go.jp
National Cerebral and Cardiovascular Center
National Cerebral and Cardiovascular Center
Other
National Cerebral and Cardiovascular Center
5-7-1, Fujishiro-dai, Suita, Osaka JAPAN
06-6833-5012
plandiv@ml.ncvc.go.jp
NO
2016 | Year | 03 | Month | 11 | Day |
Published
4
Completed
2016 | Year | 02 | Month | 26 | Day |
2016 | Year | 02 | Month | 26 | Day |
2016 | Year | 02 | Month | 27 | Day |
2018 | Year | 12 | Month | 08 | Day |
2018 | Year | 12 | Month | 08 | Day |
2016 | Year | 03 | Month | 10 | Day |
2019 | Year | 03 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024400