What is the mechanism of action of this treatment?

Cardiac Resynchronization Therapy (CRT) aims to improve the heart's efficiency and coordination by synchronizing the contractions of the left and right ventricles. The XSPLINE technology enhances CRT by using 3D ECG and CT imaging to create a detailed roadmap of the heart's electrical activation and venous anatomy. This allows for precise placement of the left ventricular (LV) lead in areas of late electrical activation, optimizing the resynchronization effect. Accurate LV lead placement is crucial as it can significantly reduce left ventricular end-systolic volume, improving cardiac function and patient outcomes.

What side effects are associated with this type of intervention?

Cardiac Resynchronization Therapy (CRT), including advanced methods like the XSPLINE technology that use 3D ECG and CT imaging for guided LV lead placement, can have several side effects. Common complications include infection at the implantation site, lead dislodgement, and device malfunction. Patients may also experience pain or discomfort at the implant site, and there is a risk of bleeding or bruising. Additionally, there can be issues related to the electrical stimulation, such as diaphragmatic stimulation or inappropriate shocks. Despite these risks, CRT is generally well-tolerated and can significantly improve heart function in patients with heart failure.

What prior FDA approvals exist?

Cardiac Resynchronization Therapy (CRT) has seen several FDA-approved treatments aimed at improving heart function in patients with heart failure. Traditional CRT devices, such as those from Medtronic, Boston Scientific, and Abbott, have been approved for their ability to synchronize the contractions of the left and right ventricles using implanted leads. These devices often incorporate advanced imaging techniques, including echocardiography and fluoroscopy, to optimize lead placement. The XSPLINE technology trial represents an evolution in this field by using 3D ECG and CT imaging to guide LV lead placement more precisely, potentially improving outcomes by targeting electrically late-activated regions of the heart.

What other types of research exist?

Promising alternatives to XSPLINE technology for CRT patients include: 1) Image-guided radiation therapy (IGRT), which uses two- or three-dimensional imaging to precisely locate the target area, minimizing the margin of normal tissue affected. 2) Stereotactic body radiation therapy (SBRT), which delivers high doses of radiation in fewer sessions with high precision. 3) Proton-beam radiation therapy, which uses charged particles to deliver high doses of radiation to the target volume while limiting exposure to surrounding tissues. These technologies offer advanced imaging and precision that can potentially enhance the outcomes of CRT by improving the accuracy of LV lead placement.

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Device

Guided CRT Implantation for Chronic Heart Failure (CRT-DRIVE Trial)

N/A

Recruiting

Led By Angelo Auricchio, MD PhD FESC

Research Sponsored by XSpline S.p.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented stable medical treatment for at least 6 months

Age ≥18 years at time of consent

Must not have

Patients with unstable angina

Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve heart device placement using a personalized plan created from advanced 3D images. It targets patients who need precise heart treatment. The detailed images help doctors place the device in the best spot to improve heart function. This therapy has emerged as an established treatment for patients with severe heart conditions and symptoms that do not respond to standard medication.

Who is the study for?

This trial is for adults over 18 with chronic heart failure, left bundle branch block (LBBB), and a specific type of heart rhythm issue. They must have symptoms of heart failure despite stable treatment for 6 months and not be pregnant or at risk of pregnancy without contraception. Exclusions include recent heart attacks, certain surgeries, severe kidney disease, other major cardiac conditions, or participation in conflicting studies.

What is being tested?

The study tests if guiding CRT implantation using XSpline—a non-invasive method combining ECG and CT imaging to create a detailed roadmap—improves outcomes. The goal is that patients will show significant improvement in the size of their left ventricle after six months compared to standard placement methods.

What are the potential side effects?

While the document does not specify side effects related to XSpline technology directly, typical risks associated with CRT implantation may include infection at the site of surgery, bleeding, lead displacement or malfunctioning equipment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My medical treatment has been stable for at least 6 months.

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I am 18 years old or older.

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I have heart failure symptoms that affect my daily activities.

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My heart's pumping ability is significantly reduced.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have unstable chest pain.

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I have severe narrowing of my heart's aortic valve.

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My kidney function is low, with an eGFR below 40 ml/min/1.73m2.

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I cannot undergo CT scans due to health reasons.

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I am on a constant heart failure medication infusion.

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I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using reliable birth control.

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I was born with a heart condition.

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I have a history of ongoing or permanent irregular heartbeat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients

Secondary study objectives

CRT procedural time difference

Feasibility of systematic use of XSpline platform for CRT implantation

Total X-ray exposure time difference

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CRT implantation guided by XSplineExperimental Treatment1 Intervention

The sample size estimation was based on two recent studies including CRT patients with similar clinical and demographic characteristics as in this study: the SMART-MSP and the SMART CRT. The SMART-MSP is a prospective, observational study that enrolled 584 CRT recipients at 52 US sites. In a typical modern CRT population, 75% of patients had a reduction of the end-systolic volume ≥ 15% at 6-month follow-up. The SMART-CRT study enrolled 699 CRT patients randomized to a treatment arm and a control group. At 6-months follow-up, a reduction of LVESV ≥15% was achieved for 67.7% of the patients in the control group and for 74.8% of those in the treatment arm. Therefore, it is assumed that in a modern CRT population at least 70% of the patients will have a reduction of the LVESV ≥15% of the baseline value at 6-months after CRT implantation. To demonstrate that this proportion of patients can be equally achieved with the approach tested in this study at least 150 patients need to be included.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cardiac Resynchronization Therapy (CRT) aims to improve the heart's efficiency and coordination by synchronizing the contractions of the left and right ventricles. The XSPLINE technology enhances CRT by using 3D ECG and CT imaging to create a detailed roadmap of the heart's electrical activation and venous anatomy. This allows for precise placement of the left ventricular (LV) lead in areas of late electrical activation, optimizing the resynchronization effect. Accurate LV lead placement is crucial as it can significantly reduce left ventricular end-systolic volume, improving cardiac function and patient outcomes.