Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

Status: Completed
Location: See all (72) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device.

• In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:

‣ Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms

⁃ Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure

• Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws

• Subject is willing and capable of providing informed consent

• Subject is willing and capable of complying with visits and procedures as defined by this protocol

Locations
United States
Alabama
Affinity Hospital, LLC d/b/a Granview Medical Center
Birmingham
Heart Center Research LLC
Huntsville
Arkansas
Cardiology Associates of NE Arkansas
Jonesboro
Arizona
University of Arizona Sarver Heart Center
Tucson
California
Glendale Adventist Medical Center
Glendale
Salinas Valley Memorial Healthcare System
Salinas
Delaware
Christiana Care Health Services
Newark
Florida
Baptist Health Research Institute
Jacksonville
Watson Clinic Center for Research, Inc
Lakeland
Winter Haven Hospital
Winter Haven
Georgia
Emory University Hospital
Atlanta
Northside Hospital
Atlanta
Iowa
University of Iowa Hospitals
Iowa City
Illinois
The University of Chicago
Chicago
St. John's Hospital
Springfield
Indiana
Heart Group at Deaconness Hospital
Newburgh
Kentucky
St. Elizabeth Healthcare
Edgewood
Baptist Health Lexington
Lexington
Massachusetts
Lahey Hospital and Medical Center
Burlington
Southcoast Health
Fall River
Michigan
Cardiovascular Institute of Michigan
Roseville
Trinity Health Michigan d/b/a Michigan Heart
Ypsilanti
Minnesota
HealthEast St. Joseph's Hospital
Saint Paul
Montana
The International Heart Institute on Montana Foundation
Missoula
North Carolina
Novant Health Heart and Vascular Institute
Charlotte
Novant Health Forsyth Medical Center
Winston-salem
New Jersey
Cardiovascular Associates of the Delaware Valley
Haddon Heights
The Valley Hospital
Paramus
New York
New York Methodist Hospital
Brooklyn
Ohio
The Ohio Health Research Institute- Grant Medical Center
Columbus
Oregon
Providence Heart Institute
Portland
Pennsylvania
Geisinger Clinic
Danville
University of Pennsylvania
Philadelphia
Pottstown Medical Specialist, Inc
Pottstown
South Carolina
Medical University of South Carolina
Charleston
South Dakota
North Central Heart
Sioux Falls
Texas
Dallas VA Research Corporation
Dallas
Michael E. DeBakey VA Medical Center
Houston
Foundation for Advancing Veterans' Health Research
San Antonio
Virginia
Virginia Commonwealth University Medical Center
Richmond
Washington
PeaceHealth Southwest Medical Center
Vancouver
Other Locations
Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Québec
France
Centre hospitalier du pays d'Aix
Aix En Provence
CHU Grenoble
Grenoble
CHRU de Lille
Lille
Hopital Saint Philibert
Lille
CHRU Hopital Pontchaillou
Rennes
Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle
Rouen
Centre Hôpital Universitaire Rangueil
Toulouse
Germany
Unfalkrankenhaus Marzahn
Berlin
University of Berlin, Charite Virchow Standort
Berlin
Uni Jena
Jena
Krankenhaus Landshut-Achdorf
Landshut
Otto-von-Guericke-Universitaet Magdeburg
Magdeburg
Ireland
Mater Misericordiae University Hospital
Dublin
Italy
Ospedale S. Orsola - Malpighi
Bologna
Azienda Sanitaria Universtitaria Integrata di Trieste
Trieste
Japan
Hirosaki University Hospital
Hirosaki-shi
Hiroshima Prefectural Hospital
Hiroshima-shi
Shinshu University Hospital
Nagano
Tokyo Medical University Hospital
Shinjuku-ku
Netherlands
St. Antonius Ziekenhuis
Nieuwegein
Spain
Hospital Infanta Cristina
Badajoz
Hospital 12 de Octubre Madrid
Madrid
Hospital Universitario La Fe
Valencia
Switzerland
Cardiocentro Ticino
Lugano
United Kingdom
Royal Sussex County Hospital
Brighton
University Hospital of Wales
Cardiff
Hammersmith Hospital
London
Freeman Hospital
Newcastle Upon Tyne
Nottingham University Hospital
Nottingham
Southampton University Hospital
Southampton
Time Frame
Start Date: 2017-08-01
Completion Date: 2020-09-15
Participants
Target number of participants: 699
Treatments
Other: SmartDelay™ algorithm
Subjects programmed with AV Delay and pacing chamber determined by SmartDelay
Other: Fixed AV Delay with BiV pacing
Subjects programmed with a Fixed AV Delay of 120ms with BiV pacing
Authors
Frank Cuoco, Kenneth Ellenbogen, Venkata Sagi, Ghulam Chaudhry, Arnoldas Giedrimas, Steven Bailin, Mohamad Sinno, Ramal Weragoda, Advay Bhatt, David Vance, Pugazhendhi Vijayaraman, Edwin Zishiri, Gregory Kidwell, Yuji Saito, Anil Rajendra, Satish Tiyyagura, Abrar Shah, Peter Ott, David Lin, Alborz Hassankhani, Michael Biehl, Seth Rials, Andrew Beaser, John Jennings, Alexi Zemsky, Jeffrey Arkles, Francis Marchlinski, Sandeep Duggal, James Stone, James Kleman, Ali Shakir, Michael Yerkey, Kollagunta Chandrasekhar, Bryon Rubery, David Dunbar, Chandrashekar Kumbar, Sanjay Dixit, Suneet Mittal, Mohammad Kooshkabadi, Mark Preminger, John Bailey, Ziad Issa, Fermin Garcia, John Sturdivant, Steven Levi, Michael Gold, Jay Dinerman, Gaurav Upadhyay, Phi Wiegn, Rodrigo Bolanos, Benjamin John, Jon Hays, John Scherschel, Radmira Greenstein, Neal Kavesh, J. Scott Allison, David Frankel, Simone Musco, Ashkan Babaie, Mark Mitchell, Thomas Carrigan, Prasanna Yelamanchili, Robert Chilton, Hemal Nayak, Faiz Subzposh, Andrew Epstein, Kevin Browne, Nathan Reed, Saman Nazarian, Jayanthi Koneru, Blair Halperin, Michael Broman, Michael Drucker, Michael Giudici, Marc Deyell, Jonathan Silver, Jeffrey Senfield, Conor Barrett, Alexander Mazur, Dan Musat, David Callans, Randle Storm, James Reiss, John Walsh, Gregory Supple, Mathew Hutchinson, James Mullin, Jihn Han, Scott Brancato, Gregory Granrud, Christine Gest, Richard Shepard, Matthew Reynolds, Tina Sichrovsky, Manoj Panday, Paul Tabereaux, Lai Chow Kok, Robert Schaller, Zaheer Yousef, Francois Philippon, Arnaud Savoure, Rudiger Braun-Dullaeus, Corinna Lenz, Bernhard Zrenner, Christophe Leclercq, Benedict Wiles, Jean Champagne, Jerome Taieb, Frederic Anselme, Pascal Defaye, Klaus-Juergen Gutleben, Yves Guyomar, Freya Lodge, Pierre Mondoly, Ralf Surber, Benedicte Godin, Alastair Gray, Sandrine Venier, Shrinivas Hebsur, Steven Mickelsen, Steven DaTorre, Michael Kaufmann, Riyad Mohama, Bharath Reddy, Rupa Bala, Pasquale Santangeli, Jonathon Adams, Piamsook Angkeow, Devi Nair, Paul Olson, Roderick Tung, Zaid Aziz, Matthew Hyman, Mihir Patel, Ryo Yamazato, Nozomu Oda, Toshinori Yuasa, Naoya Mitsuba, Yoji Urabe, Hironori Ueda, Benoit Plourde, Maurits Wijffels, Franck Molin, Cristian Martignani, Francois Regoli, Tiziano Moccetti, Fumiharu Miura, Louis Blier, Jippe Balt, Mark Tanner, Adolfo Fontenla-Cerezuela, Ayako Okada, Paul Roberts, John Paisey, Niall Campbell, Angelo Auricchio, Kenji Masada, Ahran Arnold, Takahiko Kinjo, Valeria Calvi, Shingo Sasaki, Mauro Biffi, Niall Mahon, Vincent Van Dijk, Nathaniel Hawkins, Daniel Keene, Igor Diemberger, Giulio Conte, Derek Exner, Lucas Boersma, Morio Shoda, Christian Steinberg, Matteo Ziacchi, Vishal Luther, Chris Plummer, Glen Sumner
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

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