Prosthetic paravalvular regurgitation after heart valve replacement
Conditions
Interventions
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
Sponsors
National Cerebral and Cardiovascular Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTakuya Hasegawa
National Cerebral and Cardiovascular Center Cardiovascular Medicine
Outcome results
None listed