Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:5/4/2018
Start Date:March 2008
End Date:September 2023
Contact:Ava Mayers
Phone:651-756-5576

Use our guide to learn which trials are right for you!

The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA)
in September, 2007. This study is designed to further evaluate the safety and effectiveness
in subjects implanted with the AMPLATZER Muscular VSD Occluder.


Inclusion Criteria:

1. complex congenital muscular ventricular septal defects (VSD) of significant size to
warrant closure. Subjects must meet at least one of the following:

1. Large volume left to right shunt (Qp/Qs >2:1),

2. Pulmonary hypertension (PA pressure >50% systemic) and/or

3. Clinical symptoms of congestive heart failure

4. Banding of the pulmonary artery(ies) and in the opinion of the treating
investigator closure of the VSD is clinically warranted.

2. Subjects must meet at least one of the following criteria to be considered high risk
for standard transatrial or transarterial surgical closure based on anatomical
conditions:

1. Left ventriculotomy or an extensive right ventriculotomy,

2. Failed previous VSD closure,

3. Multiple apical and/or anterior muscular VSDs ("Swiss Cheese Septum"), and/or

4. Posterior apical VSDs covered by trabeculae.

5. Overall medical condition

3. Subject/legally authorized representative has signed the informed consent

4. Subject/legally authorized representative is willing to complete the follow-up
requirements of this study

Exclusion Criteria:

1. Subjects with defects less than 4 mm distance from the semilunar (aortic and
pulmonary) or atrioventricular valves (mitral and tricuspid)

2. Subjects with severely increased pulmonary vascular resistance above 7 Wood units and
a right-to-left shunt and documented irreversible pulmonary vascular disease

3. Subjects with perimembranous (close to the aortic valve) VSD

4. Subjects with post-infarction VSD

5. Subjects who weigh < 5.2 kg

6. Subjects with sepsis (local/generalized)

7. Subjects with active bacterial infections

8. Subjects with contraindications to anti-platelets
We found this trial at
51
sites
Houston, Texas 77030
Principal Investigator: Mohammed Numan, M.D.
?
mi
from
Houston, TX
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Elman Frantz, M.D.
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Atman Shah, MD
Phone: 773-702-0347
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Russel Hirsch, M.D.
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: John P Cheatham, MD
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Gregory F Fleming, MD
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
1000 Joe DiMaggio Drive
Hollywood, Florida 33021
Principal Investigator: Kak-Chen Chan, MD
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Makram R Ebeid, MD
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Frank F. Ing, MD
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Miami Children's Hospital Welcome to Miami Children
?
mi
from
Miami, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Gurumurthy Hiremath, MD
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Albert Rocchini, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Robert Vincent, MD
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Augusta, Georgia 30912
Principal Investigator: Zahid Amin, MD
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Michael Slack, MD
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Varsha Bandisode, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Ziyad Hijazi, M.D.
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cleveland, Ohio 44195
Principal Investigator: Lourdes Prieto, MD
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Principal Investigator: Thomas Forbes, M.D.
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Henri Justino, MD
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: Mark Hoyer, MD
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Iowa City, Iowa 52242
Principal Investigator: Osamah Aldoss, MD
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Kansas City, Missouri 64108
Principal Investigator: Abhay Divekar, MD
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Lansing, Michigan 48912
Principal Investigator: Gaurav Dhar, MD
Phone: 517-364-5760
?
mi
from
Lansing, MI
Click here to add this to my saved trials
3186 Maryland Parkway
Las Vegas, Nevada 89109
Principal Investigator: Alvaro Galindo, M.D.
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
Principal Investigator: Douglas Schneider, M.D.
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
4733 Sunset Blvd
Los Angeles, California 90027
(800) 954-8000
Principal Investigator: Morris Salem, M.D.
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Madera, California 93638
Principal Investigator: Carl Owada, MD
?
mi
from
Madera, CA
Click here to add this to my saved trials
Memphis, Tennessee 38104
Principal Investigator: Benjamin R. Waller, M.D.
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33136
Principal Investigator: Satinder Sandhu, MD
?
mi
from
Miami, FL
Click here to add this to my saved trials
9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: Todd Gudausky, M.D.
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
Principal Investigator: Charles M. Baker, M.D.
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New York, New York 10032
Principal Investigator: Alejandro Torres, MD
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
Oak Lawn, Illinois 60453
Principal Investigator: Alexander Javois, M.D.
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
Orlando, Florida 32806
Principal Investigator: David Nykanen, MD
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Palo Alto, California 94304
Principal Investigator: Lynn Peng, MD
Phone: 650-721-2121
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85016
Principal Investigator: Stephen G Pophal, MD
Phone: 602-888-0788
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Principal Investigator: Shabana Shahanavaz, MD
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33701
Principal Investigator: Gary Stapleton, M.D.
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
8010 Frost Street
San Diego, California 92123
Principal Investigator: John Moore, MD
?
mi
from
San Diego, CA
Click here to add this to my saved trials
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
555 University Avenue
Toronto, Ontario M5G 1X8
Principal Investigator: Lee Benson, M.D.
?
mi
from
Toronto,
Click here to add this to my saved trials
105 Sixth St
Traverse City, Michigan 49684
(231) 935-5000
Principal Investigator: James Fox, MD
Phone: 231-935-5800
Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
?
mi
from
Traverse City, MI
Click here to add this to my saved trials
Washington, District of Columbia 20010
?
mi
from
Washington,
Click here to add this to my saved trials
Wilmington, Delaware 19803
Principal Investigator: Wolfgang Radtke, MD
?
mi
from
Wilmington, DE
Click here to add this to my saved trials