Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

Description

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

Study Start Date

August, 01 2017

Estimated Completion Date

December 2019

Interventions

  • Device: CRT-D

Study ID

Boston Scientific Corporation -- C2067

Status

Recruiting

Trial ID

NCT03089281

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

726

Sponsor

Boston Scientific Corporation

Inclusion Criteria

  • 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

Exclusion Criteria

  • Subjects with documented permanent complete AV block
  • Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment
  • Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle
  • Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD)
  • Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
  • Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)
  • Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
  • Women of childbearing potential who are or plan to become pregnant during the course of the trial
  • Subjects currently requiring dialysis

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (123)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Conor Barrett 617-726-5067 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Conor Barrett 617-726-5067 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Conor Barrett 617-726-5067 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Conor Barrett 617-726-5067 None
Lahey Hospital and Medical Center - Burlington, Massachusetts 11.0 miles Ghulam Chaudhry 781-744-8863 None
Lahey Hospital and Medical Center - Burlington, Massachusetts 11.0 miles Ghulam Chaudhry 781-744-8863 None
Lahey Hospital and Medical Center - Burlington, Massachusetts 11.0 miles Ghulam Chaudhry 781-744-8863 None
Lahey Hospital and Medical Center - Burlington, Massachusetts 11.0 miles Ghulam Chaudhry 781-744-8863 None
St Josephs Regional Medical Center - Paterson, New Jersey 187.9 miles Satish Tiyyagura None None
St Josephs Regional Medical Center - Paterson, New Jersey 187.9 miles Satish Tiyyagura None None
St Josephs Regional Medical Center - Paterson, New Jersey 187.9 miles Satish Tiyyagura None None
St Josephs Regional Medical Center - Paterson, New Jersey 187.9 miles Satish Tiyyagura None None
Cardiovascular Associates of the Delaware Valley - Haddon Heights, New Jersey 269.0 miles George Mark MD 856-546-3003 None
Cardiovascular Associates of the Delaware Valley - Haddon Heights, New Jersey 269.0 miles George Mark MD 856-546-3003 None
Cardiovascular Associates of the Delaware Valley - Haddon Heights, New Jersey 269.0 miles George Mark MD 856-546-3003 None
Cardiovascular Associates of the Delaware Valley - Haddon Heights, New Jersey 269.0 miles George Mark MD 856-546-3003 None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Robert Schaller 215-662-3999 None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Robert Schaller 215-662-3999 None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Robert Schaller 215-662-3999 None
Geisinger Clinic - Danville, Pennsylvania 301.1 miles Jess Oren None None
Geisinger Clinic - Danville, Pennsylvania 301.1 miles Jess Oren None None
Geisinger Clinic - Danville, Pennsylvania 301.1 miles Jess Oren None None
Christiana Care Health Services - Newark, Delaware 304.3 miles Piamsook Angkeow 302-733-4645 None
Christiana Care Health Services - Newark, Delaware 304.3 miles Piamsook Angkeow 302-733-4645 None
Christiana Care Health Services - Newark, Delaware 304.3 miles Piamsook Angkeow 302-733-4645 None
Virginia Commonwealth University Medical Center - Richmond, Virginia 473.4 miles Jayanthi Koneru None None
Virginia Commonwealth University Medical Center - Richmond, Virginia 473.4 miles Jayanthi Koneru None None
Virginia Commonwealth University Medical Center - Richmond, Virginia 473.4 miles Jayanthi Koneru None None
Virginia Commonwealth University Medical Center - Richmond, Virginia 473.4 miles Jayanthi Koneru None None
Trinity Health Michigan dba Michigan Heart - Ypsilanti, Michigan 640.8 miles Bipin Ravindran None None
Trinity Health Michigan dba Michigan Heart - Ypsilanti, Michigan 640.8 miles Bipin Ravindran None None
Trinity Health Michigan dba Michigan Heart - Ypsilanti, Michigan 640.8 miles Bipin Ravindran None None
Trinity Health Michigan dba Michigan Heart - Ypsilanti, Michigan 640.8 miles Bipin Ravindran None None
The Ohio Health Research Institute Grant Medical Center - Columbus, Ohio 641.8 miles Seth Rials 614-566-9840 None
The Ohio Health Research Institute Grant Medical Center - Columbus, Ohio 641.8 miles Seth Rials 614-566-9840 None
The Ohio Health Research Institute Grant Medical Center - Columbus, Ohio 641.8 miles Seth Rials 614-566-9840 None
The Ohio Health Research Institute Grant Medical Center - Columbus, Ohio 641.8 miles Seth Rials 614-566-9840 None
Novant Health Forsyth Medical Center - Winston-Salem, North Carolina 659.2 miles Lai Chow Kik 336-718-6074 None
Novant Health Forsyth Medical Center - Winston-Salem, North Carolina 659.2 miles Lai Chow Kik 336-718-6074 None
Novant Health Forsyth Medical Center - Winston-Salem, North Carolina 659.2 miles Lai Chow Kik 336-718-6074 None
Novant Health Forsyth Medical Center - Winston-Salem, North Carolina 659.2 miles Lai Chow Kik 336-718-6074 None
St Elizabeth Healthcare - Edgewood, Kentucky 742.9 miles Jon Hays 859-331-3353 None
St Elizabeth Healthcare - Edgewood, Kentucky 742.9 miles Jon Hays 859-331-3353 None
St Elizabeth Healthcare - Edgewood, Kentucky 742.9 miles Jon Hays 859-331-3353 None
St Elizabeth Healthcare - Edgewood, Kentucky 742.9 miles Jon Hays 859-331-3353 None
Baptist Health Lexington - Lexington, Kentucky 771.2 miles Gery Tomassoni 859-260-6429 None
Baptist Health Lexington - Lexington, Kentucky 771.2 miles Gery Tomassoni 859-260-6429 None
Baptist Health Lexington - Lexington, Kentucky 771.2 miles Gery Tomassoni 859-260-6429 None
Baptist Health Lexington - Lexington, Kentucky 771.2 miles Gery Tomassoni 859-260-6429 None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles John Sturdivant 843-792-2994 None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles John Sturdivant 843-792-2994 None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles John Sturdivant 843-792-2994 None
The University of Chicago - Chicago, Illinois 848.0 miles Roderick Tung 773-702-0535 None
The University of Chicago - Chicago, Illinois 848.0 miles Roderick Tung 773-702-0535 None
The University of Chicago - Chicago, Illinois 848.0 miles Roderick Tung 773-702-0535 None
The University of Chicago - Chicago, Illinois 848.0 miles Roderick Tung 773-702-0535 None
Northside Hospital - Atlanta, Georgia 929.9 miles Mohammad Kooshkanadi 404-236-8303 None
Northside Hospital - Atlanta, Georgia 929.9 miles Mohammad Kooshkanadi 404-236-8303 None
Northside Hospital - Atlanta, Georgia 929.9 miles Mohammad Kooshkanadi 404-236-8303 None
Northside Hospital - Atlanta, Georgia 929.9 miles Mohammad Kooshkanadi 404-236-8303 None
St Johns Hospital - Springfield, Illinois 982.5 miles Ziad Issa Dr 217-492-9100 None
St Johns Hospital - Springfield, Illinois 982.5 miles Ziad Issa Dr 217-492-9100 None
St Johns Hospital - Springfield, Illinois 982.5 miles Ziad Issa Dr 217-492-9100 None
St Johns Hospital - Springfield, Illinois 982.5 miles Ziad Issa Dr 217-492-9100 None
University of Iowa Hospitals - Iowa City, Iowa 1,050.4 miles Michael Giudici 319-384-2915 None
University of Iowa Hospitals - Iowa City, Iowa 1,050.4 miles Michael Giudici 319-384-2915 None
University of Iowa Hospitals - Iowa City, Iowa 1,050.4 miles Michael Giudici 319-384-2915 None
University of Iowa Hospitals - Iowa City, Iowa 1,050.4 miles Michael Giudici 319-384-2915 None
Affinity Hospital LLC dba Granview Medical Center - Birmingham, Alabama 1,051.9 miles Joaquin Arciniegas 205-971-7578 None
Affinity Hospital LLC dba Granview Medical Center - Birmingham, Alabama 1,051.9 miles Joaquin Arciniegas 205-971-7578 None
Affinity Hospital LLC dba Granview Medical Center - Birmingham, Alabama 1,051.9 miles Joaquin Arciniegas 205-971-7578 None
Affinity Hospital LLC dba Granview Medical Center - Birmingham, Alabama 1,051.9 miles Joaquin Arciniegas 205-971-7578 None
Cardiology Associates Research LLc - Tupelo, Mississippi 1,108.6 miles Karl Crossen 662-377-7456 None
Cardiology Associates Research LLc - Tupelo, Mississippi 1,108.6 miles Karl Crossen 662-377-7456 None
Cardiology Associates Research LLc - Tupelo, Mississippi 1,108.6 miles Karl Crossen 662-377-7456 None
Cardiology Associates Research LLc - Tupelo, Mississippi 1,108.6 miles Karl Crossen 662-377-7456 None
HealthEast St Josephs Hospital - Saint Paul, Minnesota 1,114.3 miles David Dunbar 651-471-2684 None
HealthEast St Josephs Hospital - Saint Paul, Minnesota 1,114.3 miles David Dunbar 651-471-2684 None
HealthEast St Josephs Hospital - Saint Paul, Minnesota 1,114.3 miles David Dunbar 651-471-2684 None
HealthEast St Josephs Hospital - Saint Paul, Minnesota 1,114.3 miles David Dunbar 651-471-2684 None
Cardiology Associates of NE Arkansas - Jonesboro, Arkansas 1,143.1 miles Devi Nair 870-935-6729 None
Cardiology Associates of NE Arkansas - Jonesboro, Arkansas 1,143.1 miles Devi Nair 870-935-6729 None
Cardiology Associates of NE Arkansas - Jonesboro, Arkansas 1,143.1 miles Devi Nair 870-935-6729 None
Winter Haven Hospital - Winter Haven, Florida 1,157.8 miles Rodrigo Bolanos 863-293-1121 None
Winter Haven Hospital - Winter Haven, Florida 1,157.8 miles Rodrigo Bolanos 863-293-1121 None
Winter Haven Hospital - Winter Haven, Florida 1,157.8 miles Rodrigo Bolanos 863-293-1121 None
Winter Haven Hospital - Winter Haven, Florida 1,157.8 miles Rodrigo Bolanos 863-293-1121 None
Watson Clinic Center for Research Inc - Lakeland, Florida 1,162.6 miles Kevin Browne None None
Watson Clinic Center for Research Inc - Lakeland, Florida 1,162.6 miles Kevin Browne None None
Watson Clinic Center for Research Inc - Lakeland, Florida 1,162.6 miles Kevin Browne None None
Watson Clinic Center for Research Inc - Lakeland, Florida 1,162.6 miles Kevin Browne None None
North Central Heart - Sioux Falls, South Dakota 1,295.1 miles Paul Olson MD 605-977-5000 None
North Central Heart - Sioux Falls, South Dakota 1,295.1 miles Paul Olson MD 605-977-5000 None
North Central Heart - Sioux Falls, South Dakota 1,295.1 miles Paul Olson MD 605-977-5000 None
North Central Heart - Sioux Falls, South Dakota 1,295.1 miles Paul Olson MD 605-977-5000 None
Foundation for Advancing Veterans Health Research - San Antonio, Texas 1,768.2 miles Manoj Panday 210-617-5300 None
Foundation for Advancing Veterans Health Research - San Antonio, Texas 1,768.2 miles Manoj Panday 210-617-5300 None
Foundation for Advancing Veterans Health Research - San Antonio, Texas 1,768.2 miles Manoj Panday 210-617-5300 None
Foundation for Advancing Veterans Health Research - San Antonio, Texas 1,768.2 miles Manoj Panday 210-617-5300 None
The International Heart Institute on Montana Foundation - Missoula, Montana 2,111.5 miles Michael Yerkey 406-329-2797 None
The International Heart Institute on Montana Foundation - Missoula, Montana 2,111.5 miles Michael Yerkey 406-329-2797 None
The International Heart Institute on Montana Foundation - Missoula, Montana 2,111.5 miles Michael Yerkey 406-329-2797 None
The International Heart Institute on Montana Foundation - Missoula, Montana 2,111.5 miles Michael Yerkey 406-329-2797 None
University of Arizona Sarver Heart Center - Tucson, Arizona 2,281.0 miles Mathew Hutchinson None None
PeaceHealth Southwest Medical Center - Vancouver, Washington 2,530.3 miles Jonathon Lowry 360-514-2016 None
PeaceHealth Southwest Medical Center - Vancouver, Washington 2,530.3 miles Jonathon Lowry 360-514-2016 None
PeaceHealth Southwest Medical Center - Vancouver, Washington 2,530.3 miles Jonathon Lowry 360-514-2016 None
PeaceHealth Southwest Medical Center - Vancouver, Washington 2,530.3 miles Jonathon Lowry 360-514-2016 None
Providence Heart Institute - Portland, Oregon 2,542.0 miles Scott Brancato MD None None
Providence Heart Institute - Portland, Oregon 2,542.0 miles Scott Brancato MD None None
Providence Heart Institute - Portland, Oregon 2,542.0 miles Scott Brancato MD None None
Providence Heart Institute - Portland, Oregon 2,542.0 miles Scott Brancato MD None None
Pacific Arrhythmia Services Inc - La Mesa, California 2,573.5 miles Alborz Hassankhani 619-874-1833 None
Pacific Arrhythmia Services Inc - La Mesa, California 2,573.5 miles Alborz Hassankhani 619-874-1833 None
Pacific Arrhythmia Services Inc - La Mesa, California 2,573.5 miles Alborz Hassankhani 619-874-1833 None
Pacific Arrhythmia Services Inc - La Mesa, California 2,573.5 miles Alborz Hassankhani 619-874-1833 None
Glendale Adventist Medical Center - Glendale, California 2,590.6 miles John McKenzie MD 818-409-8009 None
Glendale Adventist Medical Center - Glendale, California 2,590.6 miles John McKenzie MD 818-409-8009 None
Glendale Adventist Medical Center - Glendale, California 2,590.6 miles John McKenzie MD 818-409-8009 None
Glendale Adventist Medical Center - Glendale, California 2,590.6 miles John McKenzie MD 818-409-8009 None
Salinas Valley Memorial Healthcare System - Salinas, California 2,690.2 miles Yuji Saito 859-331-3353 None
Salinas Valley Memorial Healthcare System - Salinas, California 2,690.2 miles Yuji Saito 859-331-3353 None
Salinas Valley Memorial Healthcare System - Salinas, California 2,690.2 miles Yuji Saito 859-331-3353 None

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