Phase
Condition
Congestive Heart Failure
Heart Failure
Chest Pain
Treatment
CRT-D with INGEVITY+ pace/sense lead
CRT-D with a Quadripolar LV lead
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient is age 18 years or above, or of legal age to give informed consent specificto state and national law
Patient meets a guideline-based indication for a de novo CRT-D device
Primary prevention indication for ICD therapy
Ischemic or nonischemic cardiomyopathy with LVEF ≤ 35% within 6 months of enrollment (LVEF must be assessed after the subject has been on GDMT for a minimum of 3 months)using an appropriate method of assessment (i.e. Echo, MRI, etc)
NYHA class II-IV despite maximally tolerated guideline directed medical therapy (GDMT)* for at least 3 months
*GDMT is defined as all four drug classes listed below for at least 3 months priorto enrollment unless the investigator provides justification (e.g., contraindicated,not tolerated or cost): Renin Angiotensin System Inhibitors (ACE, ARB, or ARNI)Evidence based betablockers (metoprolol succinate, carvedilol, bisoprolol)Mineralocorticoid antagonists SGLT2 Inhibitor medications
Sinus rhythm with left bundle branch block (LBBB) defined as a QRS ≥ 140 ms in menand ≥ 130 ms in women with a predominantly negative deflection (QS or rS in lead V1and mid QRS notching or slurring in at least two of the following leads: 1, aVL, V1,V2, V5, V6) within 3 months of enrollment
Patient is willing to participate in LATITUDE™ NXT remote patient monitoring
Patient is willing and capable of providing informed consent and participating inall testing associated with this investigation at an approved study site and at theprotocol defined intervals (Note: Use of a legally authorized representative (LAR)is not allowed)
Patient plans to remain geographically stable (not permanently moving to anotherlocation) and can commit to all study participation requirements (procedure,follow-up visits and testing requirements)
Exclusion
Exclusion Criteria:
Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollmentand documented in the medical record
Frequent premature ventricular contractions (PVCs), atrial arrhythmias, and/or othercauses of expected percentage of cardiac physiologic pacing (CPP) delivery below 95%at the time of enrollment
Non-LBBB conduction abnormalities (including right bundle branch block (RBB) orintraventricular conduction delay (IVCD)) within 3 months prior to enrollment
Complete, second degree or high degree atrioventricular (AV) block, that requirespacing at the time of enrollment
Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICDtechnology and leadless pacemakers)
Prior or planned mechanical or bioprosthetic tricuspid valve replacement
Currently receiving or previously received positive inotrope therapy within 3 monthsprior to enrollment
Unstable angina, acute myocardial infarction, coronary artery bypass grafting, orpercutaneous coronary intervention within 3 months prior to enrollment
History of heart transplantation or left ventricular assist device (LVAD)implantation
Less than 1 year of life expectancy at the time of enrollment
Anticipated heart transplantation or LVAD implantation within 1 year of enrollment
History of ventricular septal defect (VSD)
Complex congenital heart disease
Documented diagnosis of cardiac amyloidosis
Known occlusion or other reason limiting central venous access for transvenous leads
Women of childbearing potential who are, or plan to become, pregnant during thecourse of the study (assessment per investigator's discretion)
Patient currently requiring dialysis
Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)
Patient with contrast dye allergy or unwilling/able to undergo pre-treatment withsteroids and/or diphenhydramine
Inability or refusal to comply with the follow-up schedule including subject livingat such a distance from the investigational site that attending follow-up visitswould be unusually difficult or burdensome
Patient is enrolled in any other concurrent study. Co-enrollment into other studiessuch as observational studies/registries needs prior written approval by BSC. Localmandatory governmental registries are accepted for co-enrollment without approval byBSC.
Study Design
Connect with a study center
Heart Center Research, LLC
Huntsville, Alabama 35801
United StatesActive - Recruiting
Mobile Infirmary Medical Center
Mobile, Alabama 36608
United StatesActive - Recruiting
Heart Center Research, LLC
Huntsville 4068590, Alabama 4829764 35801
United StatesSite Not Available
Mobile Infirmary Medical Center
Mobile 4076598, Alabama 4829764 36608
United StatesSite Not Available
Arrhythmia Research Group
Jonesboro, Arkansas 72401
United StatesActive - Recruiting
Arrhythmia Research Group
Jonesboro 4116834, Arkansas 4099753 72401
United StatesSite Not Available
Scripps Memorial Hospital
La Jolla, California 92037
United StatesActive - Recruiting
Alta Bates Summit Medical Center
Oakland, California 94609
United StatesActive - Recruiting
Pacific Heart Institute
Santa Monica, California 90404
United StatesActive - Recruiting
Torrance Medical Center
Torrance, California 90505
United StatesActive - Recruiting
Cardiology Associates Medical Group, Inc.
Ventura, California 93003
United StatesActive - Recruiting
Alta Bates Summit Medical Center
Oakland 5378538, California 5332921 94609
United StatesSite Not Available
Cardiology Associates Medical Group, Inc.
Ventura 5405878, California 5332921 93003
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesActive - Recruiting
Sarasota Memorial Hospital
Sarasota 4172131, Florida 4155751 34239
United StatesSite Not Available
Emory University Hospital
Atlanta, Georgia 30322
United StatesActive - Recruiting
University of Chicago
Hinsdale, Illinois 60521
United StatesActive - Recruiting
Midwest Cardiovascular Institute
Naperville, Illinois 60540
United StatesActive - Recruiting
Midwest Cardiovascular Institute
Naperville 4903279, Illinois 4896861 60540
United StatesSite Not Available
Community Heart and Vascular Hospital
Indianapolis, Indiana 46250
United StatesActive - Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
Baptist Hospital East Louisville
Louisville, Kentucky 40207
United StatesActive - Recruiting
Southcoast Physicians Group
Fall River, Massachusetts 02720
United StatesActive - Recruiting
Corewell Health
Grand Rapids, Michigan 49525
United StatesActive - Recruiting
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota 55805
United StatesActive - Recruiting
Centracare Heart and Vascular Center
Saint Cloud, Minnesota 56303
United StatesActive - Recruiting
Centracare Heart and Vascular Center
Saint Cloud 5044407, Minnesota 5037779 56303
United StatesSite Not Available
New York Hospital Queens
Flushing, New York 11355
United StatesActive - Recruiting
Rochester General Hospital
New York, New York 14621
United StatesActive - Recruiting
Weill Cornell Medical University
New York, New York 10021
United StatesActive - Recruiting
SUNY-Upstate Medical University
Syracuse, New York 13057
United StatesActive - Recruiting
New York Hospital Queens
Flushing 5117472, New York 5128638 11355
United StatesSite Not Available
Weill Cornell Medical University
New York 5128581, New York 5128638 10021
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesActive - Recruiting
OhioHealth Research and Innovation Institute-Riverside Methodist Hospital
Columbus, Ohio 43214
United StatesActive - Recruiting
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakota 57108
United StatesActive - Recruiting
Avera Heart Hospital of South Dakota
Sioux Falls 5231851, South Dakota 5769223 57108
United StatesSite Not Available
St.Thomas Health
Nashville, Tennessee 37205
United StatesActive - Recruiting
Heart Hospital Baylor Plano
Plano, Texas 75093
United StatesActive - Recruiting
Christus Trinity Mother Frances Health System
Tyler, Texas 75701
United StatesActive - Recruiting
Christus Trinity Mother Frances Health System
Tyler 4738214, Texas 4736286 75701
United StatesSite Not Available

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