CRT Device Implant for Heart Failure

(REINVENT Trial)

Recruiting at 1 trial location

Overseen By Edwinia Battle, BSN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Inova Health Care Services

Must be taking: Heart failure regimen

Must not be taking: Investigational drugs

Disqualifiers: Coronary artery disease, Angina, MI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a device called CRT (Cardiac Resynchronization Therapy) can enhance heart function and alleviate symptoms in people with heart failure. Participants will receive either BIV-CRT (Biventricular Pacing) or LB-CRT to identify the more effective option. The trial seeks individuals with heart failure who experience symptoms like difficulty breathing or fatigue, have a specific heart rhythm issue known as left bundle branch block, and demonstrate good heart function in tests. Participants should be stable on their current heart failure medications. As an unphased trial, this study provides a unique opportunity to advance medical knowledge and potentially improve heart failure treatments.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires that you are on a stable heart failure treatment plan without changes during the study.

What prior data suggests that this CRT device is safe for heart failure patients?

Research has shown that both LB-CRT and BiV-CRT treatments are generally well-tolerated by people with heart failure.

For LB-CRT, studies have found relatively low side effects. One study reported fewer hospital visits for heart failure and lower death rates over a two-year period, suggesting that LB-CRT is quite safe for patients.

BiV-CRT has also been extensively studied. Research indicates it lowers the risk of death and reduces hospital stays for heart failure, suggesting it's a safe choice for many patients.

Both treatments aim to improve heart function and symptoms, and studies support their safety with positive results. Always consult a healthcare provider before joining a trial to determine if it's right for you. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for heart failure because they offer innovative approaches to cardiac resynchronization. Unlike traditional methods, which often rely on biventricular pacing (BiV-CRT) to synchronize the heart's ventricles, Left Bundle Cardiac Resynchronization Therapy (LB-CRT) focuses specifically on correcting the left bundle branch block, a common issue in heart failure patients. This targeted approach may improve heart function more efficiently by directly addressing the electrical conduction problems. Additionally, by potentially offering a more tailored therapy, these treatments could enhance patient outcomes and quality of life.

What evidence suggests that this trial's treatments could be effective for heart failure?

This trial will compare the effectiveness of LB-CRT and BiV-CRT in treating heart failure. Studies have shown that Left Bundle Cardiac Resynchronization Therapy (LB-CRT) improves heart function more effectively than traditional methods by significantly reducing the QRS duration, a measure of heart efficiency. Research has indicated that Cardiac Resynchronization Therapy (CRT), including Biventricular Cardiac Resynchronization Therapy (BiV-CRT), can lower the risk of death and hospital visits for heart failure patients. BiV-CRT enhances the heart's pumping ability, particularly in patients with a wide QRS interval. Both treatments in this trial aim to improve heart function and symptoms in heart failure patients, offering promising benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Brett Atwater, MD

Principal Investigator

Inova Health Care Services

Are You a Good Fit for This Trial?

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

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.

You have previously had a tricuspid valve replaced with a mechanical one.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo implantation of a CRT device and are randomly allocated to either LB-CRT or BiV-CRT for 3 months

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BIV-CRT
• LB-CRT

Trial Overview 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.

How Is the Trial Designed?

Group I: Sequence 2 Experimental Treatment 2 Interventions

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

Group II: Sequence 1 Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials

80

Recruited

22,700+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Published Research Related to This Trial

In a study involving 176 patients with heart failure, left ventricular (LV) pacing was found to be noninferior to biventricular (BiV) pacing in terms of clinical and echocardiographic responses after 6 months, indicating that LV-only stimulation can be as effective as BiV stimulation.

Both pacing methods showed similar improvement rates in heart failure symptoms, with 76.2% of BiV patients and 74.7% of LV patients responding positively, suggesting that LV pacing could be a viable alternative to BiV pacing for patients with specific heart failure characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized double-blind comparison of biventricular versus left ventricular stimulation for cardiac resynchronization therapy: the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial. Boriani, G., Kranig, W., Donal, E., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3382419/

Biventricular Pacing (Cardiac Resynchronization Therapy) The goal of treatment with BiV pacing is to improve cardiac output for people in heart failure (HF) with conduction defect on ECG (wide QRS interval)

2. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)00242-X/fulltext

Comparisons of long-term clinical outcomes with left ... Cardiac resynchronization therapy (CRT) with biventricular pacing (BiVP-CRT) reduces all-cause mortality and heart failure hospitalization (HFH) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1071916425001617

Evolving Indications, Challenges and Advances in Cardiac ... Cardiac resynchronization therapy (CRT) via biventricular pacing has markedly improved heart failure outcomes over the past 2 decades.

4. jacc.org jacc.org/doi/10.1016/j.jacep.2022.08.001

Conduction System Pacing vs Biventricular Pacing in Heart ... This study aims to compare ventricular resynchronization achieved by CSP vs BiVP in patients with cardiac resynchronization therapy indication.

5. ahajournals.org ahajournals.org/doi/10.1161/circ.128.suppl_22.A11330

The Influence of Percent Biventricular Pacing on CRT ... Background: Previous studies have found optimal benefit of cardiac resynchronization therapy (CRT) with biventricular (BIV) pacing above 92%.

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.118.006613

Permanent His Bundle Pacing for Cardiac ... His bundle pacing was effective in achieving electric resynchronization in patients with right bundle branch block and cardiomyopathy. •. His ...