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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months follow-up
Awards & highlights
CRT-DRIVE Trial Summary
This trial is designed to study whether a cloud-based pre-procedural multimodality CRT-roadmap can be used to guide LV lead placement to a coronary vein in an electrically late-activated region, in order to improve the efficacy of CRT.
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.Check my eligibility
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.See study design
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.
CRT-DRIVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
CRT-DRIVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients
Secondary outcome measures
CRT procedural time difference
Feasibility of systematic use of XSpline platform for CRT implantation
Total X-ray exposure time difference
CRT-DRIVE 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.
Find a Location
Who is running the clinical trial?
XSpline S.p.A.Lead Sponsor
Angelo Auricchio, MD PhD FESCPrincipal InvestigatorIstituto Cardiocentro Ticino
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a heart attack in the last 40 days.My medical treatment has been stable for at least 6 months.I am 18 years old or older.I have unstable chest pain.I have heart failure symptoms that affect my daily activities.I haven't had any heart procedures in the last 6 months.I am being considered for a specific type of heart pacing.I am eligible for CRT based on recent heart guidelines.I had heart bypass or valve surgery in the last 90 days.Your heart is beating normally.You have had a pacemaker or ICD implanted before.You have a mechanical heart valve on the right side.My heart's pumping ability is significantly reduced.You need a pacemaker because your heart beats too slowly.I have severe narrowing of my heart's aortic valve.My kidney function is low, with an eGFR below 40 ml/min/1.73m2.I have had a heart transplant, am on the transplant list, or likely to have one soon.I cannot undergo CT scans due to health reasons.Your heart's QRS duration is longer than 130 milliseconds.You have a device to help your heart pump blood.I am on a constant heart failure medication infusion.I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using reliable birth control.I was born with a heart condition.I have a history of ongoing or permanent irregular heartbeat.You have a condition called left bundle branch block.
Research Study Groups:
This trial has the following groups:- Group 1: CRT implantation guided by XSpline
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you give me a ballpark number of how many locations are conducting this research?
"Currently, there are 5 study locations that are operational. These locations are: Rush University Medical center in Chicago, The University of Chicago Medicine in Durham, Duke University Hospital in Richmond, as well as 5 other sites."
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