Is NCT07069738 recruiting in Torrance, CA?

Yes, NCT07069738 is currently recruiting participants at its Torrance, CA location. This heart failure - nyha ii - iv clinical trial is actively enrolling qualified participants.

How do I join the heart failure - nyha ii - iv clinical trial in Torrance?

To join this clinical trial in Torrance, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Torrance clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Heart Failure - NYHA II - IV Clinical Trial in Torrance, CA

About This Heart Failure - NYHA II - IV Study in Torrance

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. This method is called Cardiac Resynchronization Therapy (CRT). 2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.

Sponsor: Boston Scientific Corporation

Who Can Participate

Inclusion Criteria

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. 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 prior to 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 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 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 in all testing associated with this investigation at an approved study site and at the protocol defined intervals (Note: Use of a legally authorized representative (LAR) is not allowed)

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)

Exclusion Criteria

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 co-enrollment without approval by BSC.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Torrance?

Yes, this clinical trial (NCT07069738) has an active research site in Torrance, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Heart Failure - NYHA II - IV Treatment Options in Torrance, CA

If you're searching for heart failure - nyha ii - iv treatment options in Torrance, CA, this clinical trial (NCT07069738) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Torrance research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart failure - nyha ii - iv specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all heart failure - nyha ii - iv clinical trials near you to find additional studies recruiting in your area.

Heart Failure - NYHA II - IV Clinical Trial in Torrance, CA

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