Heart Failure Clinical Trial

Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy

Summary

The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%

View Full Description

Full Description

The Impulse Dynamics OPTIMIZER Smart Pre-Market Application (PMA) clinical data confirmed that CCM therapy delivered with the Optimizer meaningfully improved health outcomes in patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45%. CCM has shown significant improvements in quality of life measures, with an average improvement of >11 points in MLHWFQ incremental to the improvement of a randomized control group with no device. Six minute hall walk and functional class also showed improvements in the PMA data. The post-approval study (PAS) protocol has been designed to evaluate long term safety and efficacy of the OPTIMIZER Smart in a real-world setting.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient provides written authorization and/or consent per institution and geographical requirements
Male or non-pregnant female, aged 18 or older
Left ventricular ejection fraction of 25-45% (inclusive, per site assessment)
NYHA Class III heart failure symptoms
Stated willingness to comply with all study procedures and availability for the duration of the study
Patient has been treated with guideline-directed medical therapy

Exclusion Criteria:

Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
Myocardial infarction within 90 days prior to implant
Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
Prior heart transplant or ventricular assist device
Mechanical tricuspid valve
Receiving cardiac resynchronization therapy (CRT) or has a Class I indication for CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
Participating in a cardiac investigational study at the same time
Patient is in a vulnerable population (such as significant mental disability, prisoner) that in the judgement of the PI impedes ability to provide informed consent.

Study is for people with:

Heart Failure

Estimated Enrollment:

620

Study ID:

NCT03970343

Recruitment Status:

Recruiting

Sponsor:

Impulse Dynamics

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There are 75 Locations for this study

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CardioVascular Associates of Mesa (CVAM)
Mesa Arizona, 85206, United States More Info
Adam Gitkin
Contact
480-641-5400
[email protected]
Spencer DiSparti
Contact
480-641-5400
[email protected]
Ambrose Panico, MD
Principal Investigator
Chan Heart Rhythm Institute (CHRI)
Mesa Arizona, 85206, United States More Info
Olivia Rivera
Contact
520-437-9833
[email protected]
Rodrigo Chan, MD
Principal Investigator
Southwest Cardiovascular Associates
Mesa Arizona, 85206, United States More Info
Kim Helgeson
Contact
480-945-4343
[email protected]
Angela Baker
Contact
480-945-4343
[email protected]
Charles Jost, MD
Principal Investigator
Banner University Medical Center
Phoenix Arizona, 85006, United States More Info
Raeven Maxwell
Contact
623-694-1275
[email protected]
Radha Gopalan, MD
Principal Investigator
Cardiovascular Society of Arizona
Phoenix Arizona, 85006, United States More Info
Helen Foughi
Contact
480-818-0492
[email protected]
Nathan Laufer, MD
Principal Investigator
Arizona Cardiovascular Research Center
Phoenix Arizona, 85016, United States More Info
Revathy Vilasan
Contact
602-456-2342
[email protected]
Vijendra Swarup, MD
Principal Investigator
Honor Health
Scottsdale Arizona, 85258, United States More Info
Cheryl Gresham
Contact
480-323-1229
[email protected]
Thomas Mattioni, MD
Principal Investigator
Pima Heart and Vascular Research Center
Tucson Arizona, 85712, United States More Info
Bart Torre
Contact
717-615-0659
[email protected]
Darren Peress, MD
Principal Investigator
Pima Heart & Vascular
Tucson Arizona, 85719, United States More Info
Bart Torre
Contact
520-975-6400
[email protected]
Darren Peress, MD
Principal Investigator
University of AZ - Sarver Heart Center
Tucson Arizona, 85724, United States More Info
Lizzette Cruz
Contact
520-626-5431
[email protected]
Mathew Hutchinson, MD
Principal Investigator
Cardiovascular Institute of San Diego
Chula Vista California, 91911, United States More Info
Janet Lawrence
Contact
619-616-2100
[email protected]
Burhan Mohamedali, MD
Principal Investigator
Steven Carlson, MD
Sub-Investigator
NorthBay Health, Heart and Vascular
Fairfield California, 94533, United States More Info
Belmary Astacio
Contact
707-646-4400
[email protected]
Milind Dhond, MD
Principal Investigator
Mid Valley Cardiology - Fresno
Fresno California, 93720, United States More Info
Carmen Martinez
Contact
559-801-5854
[email protected]
Michael L Krueger, DO
Principal Investigator
University of Southern California - Keck School of Medicine
Los Angeles California, 90033, United States More Info
Melissa Ramos
Contact
818-309-5542
[email protected]
Andrew Zadeh, MD
Principal Investigator
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States More Info
Tracey Early
Contact
310-423-1231
[email protected]
Goran Stankovic
Contact
310-423-1620
[email protected]
Lawrence Czer, MD
Principal Investigator
Valley Clinical Trials
Northridge California, 91325, United States More Info
Alex Chila
Contact
626-340-1687
[email protected]
Mehrdad Ariani, MD
Principal Investigator
Valley Clinical Trials
Pasadena California, 91105, United States More Info
Lisa Nakatani
Contact
[email protected]
Tishangi Kumar, MD
Principal Investigator
Torrance Memorial Medical Center
Torrance California, 90505, United States More Info
Jaquelina Patti
Contact
310-257-5781
[email protected]
Suellen Hosino
Contact
[email protected]
Erol Kosar, MD
Principal Investigator
Aurora Denver Cardiology Associates
Aurora Colorado, 80012, United States More Info
Christopher Dutka
Contact
303-597-4243
[email protected]
Chris Porterfield, MD
Principal Investigator
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States More Info
Meseret Deressa
Contact
202-877-0140
[email protected]
David Strouse, MD
Principal Investigator
Heart Rhythm Solutions
Davie Florida, 33328, United States More Info
Jessica Wilkins
Contact
954-707-5200
[email protected]
Awais Humayun, MD
Principal Investigator
Florida Memorial Hospital
Jacksonville Florida, 32216, United States More Info
Robin Serdynski
Contact
904-702-4216
[email protected]
Elizabeth Breting
Contact
904-702-4216
[email protected]
Robert J. Kim, MD
Principal Investigator
Naples Heart Rhythm Specialists
Naples Florida, 34119, United States More Info
Jori Richardson
Contact
239-330-5670
[email protected]
Kenneth Plunkitt, MD
Principal Investigator
Andrew Yin, MD
Sub-Investigator
Florida Cardiology
Orlando Florida, 32792, United States More Info
Saif Memon
Contact
407-965-9848
[email protected]
Usman Siddiqui, MD
Principal Investigator
Piedmont Heart
Atlanta Georgia, 30309, United States
Redmond Regional Medical Center
Rome Georgia, 30165, United States More Info
Kathy Jones
Contact
706-802-3139
[email protected]
Robert Styperek, MD
Principal Investigator
Advocate Illinois Masonic Medical Center
Chicago Illinois, 60657, United States
Advocate Good Samaritan Hospital
Downers Grove Illinois, 60515, United States
Baptist Lexington
Lexington Kentucky, 40503, United States More Info
Kristie Schneider
Contact
859-260-6429
[email protected]
Gery Tomassoni, MD
Principal Investigator
Craig McCotter, MD
Sub-Investigator
Johan Aasbo, MD
Sub-Investigator
University of Kentucky - Gill Heart & Vascular Institute Clinical Research
Lexington Kentucky, 40536, United States More Info
Ben Rushing
Contact
859-323-5259
[email protected]
Ronald T. Smith
Contact
859-323-7195
[email protected]
Aaron Hesselson, MD
Principal Investigator
Karen Ellison, MD
Sub-Investigator
Sparrow Clinical Research Institute
Lansing Michigan, 48912, United States More Info
Lonna Blaske
Contact
517-364-5115
[email protected]
Sandra Mitchell
Contact
517-364-5737
[email protected]
Ascension Providence Park Hospital
Novi Michigan, 38374, United States More Info
Candice Edillo
Contact
248-465-5485
[email protected]
Nathan Foster, MD
Principal Investigator
St. Joseph Mercy Oakland
Pontiac Michigan, 48341, United States More Info
Lynn Boomer
Contact
248-858-3756
[email protected]
Rajiv Nair, MD
Principal Investigator
Aaref Badshah, MD
Sub-Investigator
Downriver Heart and Vascular
Southgate Michigan, 48195, United States More Info
Mukhtar Nasser
Contact
313-717-2400
[email protected]
Qaiser Shafiq, MD
Principal Investigator
Minneapolis Heart Institute Foundation - Allina
Minneapolis Minnesota, 55407, United States More Info
Jessica Whelan
Contact
612-863-1661
[email protected]
Jay Sengupta, MD
Principal Investigator
St. Louis Heart and Vascular
Bridgeton Missouri, 63044, United States More Info
Julia Myers
Contact
405-608-1284
[email protected]
Rafiq Ramadan, MD
Principal Investigator
Cooper Hospital
Haddon Heights New Jersey, 08035, United States More Info
Erin Siderio
Contact
856-582-2000
[email protected]
George Mark, MD
Principal Investigator
Virtua Health - Our Lady of Lourdes
Marlton New Jersey, 08053, United States More Info
Marissa Brown
Contact
856-673-1346
[email protected]
Heath Saltzman, MD
Principal Investigator
Darius Sholevar, MD
Sub-Investigator
George Mark, MD
Sub-Investigator
Steven Levi, MD
Sub-Investigator
Matthew Sandler, MD
Sub-Investigator
Morristown Medical Center
Morristown New Jersey, 07960, United States More Info
Jessica Bukhari
Contact
973-971-8597
[email protected]
Christine Ciprich
Contact
[email protected]
Abhishek Singh, MD
Principal Investigator
Jersey Shore University Medical Center
Neptune New Jersey, 07753, United States More Info
Anne DeToro
Contact
732-776-3499
[email protected]
Mark Mascarenhas, MD
Principal Investigator
Rutgers Medical School
Newark New Jersey, 07719, United States More Info
Jamie Lau
Contact
973-972-6806
[email protected]
Emad Aziz, MD
Principal Investigator
Alfonso Waller, MD
Sub-Investigator
Valley Hospital
Ridgewood New Jersey, 07450, United States More Info
Lauren Tedeschi
Contact
201-447-8453
[email protected]
Rhama Castro
Contact
[email protected]
Suneet Mittal, MD
Principal Investigator
Mount Sinai Morningside
New York New York, 10025, United States More Info
Ammy Alburo-Malinay
Contact
212-523-3281
[email protected]
Ranjit Suri, MD
Principal Investigator
Mission Health
Asheville North Carolina, 28801, United States More Info
Alex Boyd
Contact
828-989-9967
[email protected]
John Rhyner
Principal Investigator
Atrium Health
Charlotte North Carolina, 28204, United States More Info
Connie Dellinger
Contact
704-355-4795
[email protected]
Rohit Mehta, MD
Principal Investigator
NC Heart and Vascular Research
Raleigh North Carolina, 27607, United States More Info
Penny Robinson
Contact
[email protected]
Sameh Mobarek, MD
Principal Investigator
TriHealth Hatton
Cincinnati Ohio, 45242, United States More Info
Laurie Freel
Contact
513-865-1148
[email protected]
Dilesh Patel, MD
Principal Investigator
University Hospitals of Cleveland Medical Center
Cleveland Ohio, 44106, United States More Info
Amy McKnight
Contact
330-501-8215
[email protected]
Ivan Cakulev, MD
Principal Investigator
The Ohio State University
Columbus Ohio, 43210, United States More Info
Anthony Belknap
Contact
614-292-6789
[email protected]
Maeve McLoughlin
Contact
614-292-4084
[email protected]
Ajay Vallakati, MD
Principal Investigator
Mount Carmel Research institute
Columbus Ohio, 43213, United States More Info
Mary Beth McCleary
Contact
614-546-4297
[email protected]
Lee Gemma, MD
Principal Investigator
Regional Cardiac Arrythmia Inc.
Steubenville Ohio, 43952, United States More Info
Emily Anderson
Contact
740-792-4220
[email protected]
Holly Bright
Contact
740-792-4220
[email protected]
Maninder Bedi, MD
Principal Investigator
ProMedica Health Systems
Toledo Ohio, 43606, United States More Info
Abeer Abu-Saif
Contact
419-842-3547
[email protected]
Diane
Contact
Timothy Phelan, MD
Principal Investigator
Mercy Health - St. Vincent Medical Center
Toledo Ohio, 43608, United States More Info
Michelle Hickam
Contact
419-251-4919
[email protected]
Ameer Kabour, MD
Principal Investigator
Oklahoma Heart Hospital
Oklahoma City Oklahoma, 73120, United States More Info
Julia Myers
Contact
405-608-3200
[email protected]
Jenny Stewart
Contact
405-608-3200
[email protected]
Charles Te, MD
Principal Investigator
St. Luke's University Health Network
Allentown Pennsylvania, 18104, United States More Info
Thomas Parson
Contact
[email protected]
Susan Hahn
Contact
484-526-7825
[email protected]
Steve Stevens, MD
Principal Investigator
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States More Info
Morgan Battiste
Contact
610-525-1202
[email protected]
Sheetal Chandhok, MD
Principal Investigator
UPMC Pinnacle Health
Harrisburg Pennsylvania, 17011, United States More Info
Gretchen Meise
Contact
717-920-4400
[email protected]
Roberto Hodara, MD
Principal Investigator
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States More Info
Heather Reesor
Contact
717-531-1452
[email protected]
Howard Eisen, MD
Principal Investigator
Penn Medicine Lancaster General Hospital
Lancaster Pennsylvania, 17602, United States More Info
Andy Hershey
Contact
717-544-1412
[email protected]
Matthew Bernabei, MD
Principal Investigator
Cardiology Consultants of Philadelphia
Philadelphia Pennsylvania, 19067, United States More Info
Sharon Budzinski
Contact
215-321-7400
[email protected]
Christopher Schulze, MD
Principal Investigator
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Penn Presybyterian Medical Center
Philadelphia Pennsylvania, 19104, United States More Info
Katie Shoemaker
Contact
856-630-1547
[email protected]
Benjamin D'Souza, MD
Principal Investigator
Temple University Hospital
Philadelphia Pennsylvania, 19140, United States More Info
Sharon Collins
Contact
215-707-0127
[email protected]
Isaac Whitman, MD
Principal Investigator
Anju Basil, MD
Sub-Investigator
Albert Einstein Medical Center
Philadelphia Pennsylvania, 19141, United States More Info
Christiana Carns
Contact
215-456-7316
[email protected]
David Kwon
Contact
215-456-6736
[email protected]
Sumeet Mainigi, MD
Principal Investigator
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States More Info
Jessica Burkardt
Contact
412-359-8497
[email protected]
Matthew Lander, MD
Principal Investigator
UPMC Heart and Vascular Institute
Pittsburgh Pennsylvania, 15213, United States More Info
Eric Pasquantonio
Contact
412-647-8210
[email protected]
Susan Sweeny
Contact
412-864-1420
[email protected]
Sandeep Jain, MD
Principal Investigator
Reading Hospital | Tower Health
Reading Pennsylvania, 19611, United States More Info
Ellie Alderfer
Contact
484-628-8360
[email protected]
Jared Green, MD
Principal Investigator
Reading Hospital
Reading Pennsylvania, 19611, United States More Info
Crystal Nagle
Contact
484-628-4308
[email protected]
Mary Alderfer
Contact
[email protected]
Jared Green, MD
Principal Investigator
David Scollan, MD
Sub-Investigator
Cardiovascular Consultants of Philadelphia
Yardley Pennsylvania, 19067, United States More Info
Sharon Budzinski
Contact
215-321-7400
[email protected]
Christopher Schulze, MD
Principal Investigator
Texas Cardiac Arrhythmia Research
Austin Texas, 78705, United States More Info
Deb Cardinal
Contact
512-522-9410
[email protected]
Robert Canby, MD
Principal Investigator
VA North Texas Medical Center
Dallas Texas, 75216, United States More Info
Kathryn Anderson
Contact
214-857-3048
[email protected]
D'Angelo Grant
Contact
214-857 3402
d'[email protected]
Phi Wiegn, MD
Principal Investigator
Texan Procedure Center
El Paso Texas, 79915, United States More Info
Christy Willis
Contact
915-867-7860
[email protected]
Ali Nasur, MD
Principal Investigator
Baylor College of Medicine
Houston Texas, 77030, United States More Info
Stephen Harold
Contact
713-798-7227
[email protected]
Mihail Chelu, MD
Principal Investigator
UT Health - Memorial Hermann Hospital
Houston Texas, 77030, United States More Info
Chandni Patel
Contact
713-500-7572
[email protected]
Taylor Layton
Contact
713-486-7309
[email protected]
Anju Bhardwaj, MD
Principal Investigator
Heart and Rhythm Institute of South Texas
San Antonio Texas, 78229, United States More Info
Joelle Bouldoukian-Choucair
Contact
[email protected]
Wassim Choucair, MD
Principal Investigator
CHRISTUS Trinity Clinic Research
Tyler Texas, 75702, United States More Info
Carol Cushman
Contact
903-606-8846
[email protected]
Joni Farmer
Contact
903-606-1621
[email protected]
Stan Weiner, MD
Principal Investigator
John Sims, MD
Sub-Investigator
Centra Health- Lynchburg General Hospital
Lynchburg Virginia, 24501, United States More Info
Cindy Baumann
Contact
434-200-2727
[email protected]
Matthew Sackett, MD
Principal Investigator
Bon Secours St. Mary's Hospital
Midlothian Virginia, 23114, United States More Info
Janet Barrett
Contact
804-794-6400
[email protected]
Harpreet Grewal, MD
Principal Investigator
HCA Chippenham Hospital
Richmond Virginia, 23225, United States More Info
Stephanie Burton
Contact
804-852-2747
[email protected]
Guru Mohanty, MD
Principal Investigator
CAMC Clinical Trials Center
Charleston West Virginia, 25304, United States
Marshall Cardiology
Huntington West Virginia, 25701, United States More Info
Melissa Marcum
Contact
304-691-8560
[email protected]
Carlos Rueda, MD
Principal Investigator
Paul Okhumale, MD
Sub-Investigator
Aurora Research Institute
Milwaukee Wisconsin, 53215, United States More Info
Rebecca Stebnitz
Contact
262-249-5432
[email protected]
Anthony Chambers
Contact
414-385-2565
[email protected]
Imran Niazi, MD
Principal Investigator
Mohamed Hani, MD
Sub-Investigator
Jodi Zilinski, MD
Sub-Investigator
Mohammad Mortada, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

620

Study ID:

NCT03970343

Recruitment Status:

Recruiting

Sponsor:


Impulse Dynamics

How clear is this clinincal trial information?

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