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

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.

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 data supports the effectiveness of the treatment BIV-CRT for heart failure?

Research shows that biventricular pacing, a key part of BIV-CRT, improves heart function and reduces hospital visits and death rates in heart failure patients with specific heart conditions. Studies also indicate that it enhances quality of life and exercise capacity for these patients. ^{1 2 3 4 5}

Is the CRT Device Implant for Heart Failure generally safe for humans?

Research shows that biventricular pacing, also known as cardiac resynchronization therapy (CRT), is generally safe for humans. Studies have demonstrated improvements in heart function and quality of life, and a significant reduction in all-cause mortality for certain heart failure patients. ^{3 4 6 7 8}

How is the BIV-CRT treatment for heart failure different from other treatments?

BIV-CRT (Biventricular Pacing) is unique because it involves pacing both the right and left ventricles of the heart to improve coordination and efficiency, unlike traditional treatments that may only pace one side. This approach can reduce hospitalizations and mortality in severe heart failure patients by improving heart function. ^{2 9 10 11 12}

Research Team

Brett Atwater, MD

Principal Investigator

Inova Health Care Services

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

RV-only pacing can produce a Q wave in lead 1 and an R wave in V1: implications for biventricular pacing. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Meta-analysis of randomized controlled trials evaluating left ventricular vs. biventricular pacing in heart failure: effect on all-cause mortality and hospitalizations. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Real-world experience of leadless left ventricular endocardial cardiac resynchronization therapy: A multicenter international registry of the WiSE-CRT pacing system. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Cardiac resynchronisation may reduce all-cause mortality: meta-analysis of preliminary COMPANION data with CONTAK-CD, InSync ICD, MIRACLE and MUSTIC. [2007]

5. Italy pubmed.ncbi.nlm.nih.gov

A review of factors contributing to health related quality of life achieved with cardiac resynchronization therapy for heart failure. [2015]

6. United States 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. [2016]

7. Canada pubmed.ncbi.nlm.nih.gov

Biventricular pacing (cardiac resynchronization therapy): an evidence-based analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Pacing-induced increase in QT dispersion predicts sudden cardiac death following cardiac resynchronization therapy. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Short-Term Hemodynamic and Electrophysiological Effects of Cardiac Resynchronization by Left Ventricular Septal Pacing. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Interventional device implantation, Part I: Basic techniques to avoid complications: A hands-on approach. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Left ventricular endocardial pacing in the real world: Five years of experience at a single center. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

A comparison of cardiac resynchronization by sequential biventricular pacing and left ventricular pacing to simultaneous biventricular pacing: rationale and design of the DECREASE-HF clinical trial. [2019]