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Compares treatment options for Heart Failure - NYHA II - IV
Official title Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
ClinicalTrials.gov ID: NCT07069738
What this study is testing
- What it's testing
- This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient is age 18 years or above, or of legal age to give informed consent specific to 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...
- NYHA class II-IV despite maximally tolerated guideline directed medical therapy (GDMT)\ for at least 3 months \ GDMT is defined as all four drug...
You likely can't join if
- Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollment and documented in the medical record
- Frequent premature ventricular contractions (PVCs), atrial arrhythmias, and/or other causes of expected percentage of cardiac physiologic pacing...
- Non-LBBB conduction abnormalities (including right bundle branch block (RBB) or intraventricular conduction delay (IVCD)) within 3 months prior to...
- Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment
- Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICD technology and leadless pacemakers)
- Prior or planned mechanical or bioprosthetic tricuspid valve replacement
See the full eligibility criteria
Who can join
- Patient is age 18 years or above, or of legal age to give informed consent specific to 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...
- 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 prior to enrollment unless the...
- Sinus rhythm with left bundle branch block (LBBB) defined as a QRS ≥ 140 ms in men and ≥ 130 ms in women with a predominantly negative deflection (QS or rS in lead V1 and mid QRS notching or slurring in at least two of...
- Patient is willing to participate in LATITUDE™ NXT remote patient monitoring
- Patient is willing and capable of providing informed consent and participating in all testing associated with this investigation at an approved study site and at the protocol defined intervals (Note: Use of a legally...
- Patient plans to remain geographically stable (not permanently moving to another location) and can commit to all study participation requirements (procedure, follow-up visits and testing requirements)
What rules you out
- Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollment and documented in the medical record
- Frequent premature ventricular contractions (PVCs), atrial arrhythmias, and/or other causes 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) or intraventricular conduction delay (IVCD)) within 3 months prior to enrollment
- Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment
- Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICD technology and leadless pacemakers)
- Prior or planned mechanical or bioprosthetic tricuspid valve replacement
- Currently receiving or previously received positive inotrope therapy within 3 months prior to enrollment
- Unstable angina, acute myocardial infarction, coronary artery bypass grafting, or percutaneous 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 the course 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 with steroids and/or diphenhydramine
- Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational site that attending follow-up visits would be unusually difficult or burdensome
- Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies/registries needs prior written approval by BSC. Local mandatory governmental registries are accepted for...
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Mobile, Alabama, United States
- Jonesboro, Arkansas, United States
- La Jolla, California, United States
- Las Angeles, California, United States
- Oakland, California, United States
- Santa Monica, California, United States
- Torrance, California, United States
- Ventura, California, United States
- Washington D.C., District of Columbia, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Altanta, Georgia, United States
- Hinsdale, Illinois, United States
- Naperville, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Louisville, Kentucky, United States
- Fall River, Massachusetts, United States
- Grand Rapids, Michigan, United States
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Mobile, Alabama, United States; Jonesboro, Arkansas, United States; La Jolla, California, United States; Las Angeles, California, United States; Oakland, California, United States and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.