CRT Device Implant for Heart Failure
(REINVENT Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byBrett Atwater, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Inova Health Care Services

No Placebo Group

Trial Summary

What is the purpose of this trial?Primary Objective - To determine if implantation of a permanent CRT pacing device (with LB-CRT, or conventional BiV-CRT with a coronary sinus LV lead) can improve electromechanical function, HF symptoms, and natriuretic peptide levels among patients with symptomatic HF, LVEF \> 35%, and LBBB.

Eligibility Criteria

This trial is for adults over 18 with heart failure, left ventricular ejection fraction greater than 35%, and a specific heart rhythm issue (LBBB). They must be on stable heart failure medication, able to give consent, and willing to follow the study plan. Pregnant women or those with certain medical conditions like chronic lung disease or recent heart procedures are excluded.

Inclusion Criteria

For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

I have heart failure but can still walk, or I've been hospitalized for it before.

Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization

+6 more

Exclusion Criteria

I have not had a fever or flu-like symptoms in the last 3 days.

I haven't had recent heart surgery or a heart attack in the last 3 months.

I need oxygen for a chronic lung condition.

+12 more

Participant Groups

The REINVENT-CRT trial is testing whether implanting a CRT pacing device using either LB-CRT or conventional BiV-CRT can improve heart function, symptoms of heart failure, and levels of natriuretic peptides in patients with symptomatic heart failure but not severely reduced left ventricular function.

2Treatment groups

Experimental Treatment

Group I: Sequence 2Experimental Treatment2 Interventions

BiV-CRT - Biventricular Pacing Cardiac Resynchronization Therapy. Participants will spend 3 months in this group

Group II: Sequence 1Experimental Treatment2 Interventions

LB-CRT - Left Bundle Cardiac Resynchronization Therapy, Participants will spend 3 months in this group

BIV-CRT is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Biventricular Pacing for:

Heart failure with reduced ejection fraction (LVEF ≤35%) and left bundle branch block (LBBB)
Heart failure with reduced ejection fraction (LVEF ≤35%) and wide QRS

🇺🇸 Approved in United States as Biventricular Pacing for:

Heart failure with reduced ejection fraction (LVEF ≤35%) and left bundle branch block (LBBB)
Heart failure with reduced ejection fraction (LVEF ≤35%) and wide QRS