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Cardiac Resynchronization Therapy
CRT Device Implant for Heart Failure (REINVENT Trial)
N/A
Recruiting
Led By Brett Atwater, MD
Research Sponsored by Inova Health Care Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
NYHA II/III, ambulatory NYHA IV, or NYHA I HF with any prior history of HF symptom decompensation requiring hospitalization, ED visit, or outpatient visit for care with IV diuretic
On a stable guideline directed HF medical regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 month treatment period after each pacing mode
Awards & highlights
REINVENT Trial Summary
This trial tests if a device implant can improve heart failure symptoms, and reduce levels of a peptide that indicates heart failure.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from the CRT devices may include discomfort at the implant site, infection risk, lead displacement requiring repositioning surgery, bleeding complications during implantation procedure, and rarely device malfunction.
REINVENT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have heart failure but can still walk, or I've been hospitalized for it before.
Select...
I am on a stable heart failure medication plan.
REINVENT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 3 month treatment period after each pacing mode
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 month treatment period after each pacing mode
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in myocardial performance index (MPI) as compared to Baseline
REINVENT Trial Design
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
Find a Location
Who is running the clinical trial?
Inova Health Care ServicesLead Sponsor
69 Previous Clinical Trials
22,239 Total Patients Enrolled
MedtronicIndustry Sponsor
606 Previous Clinical Trials
828,645 Total Patients Enrolled
3 Trials studying Left Bundle Branch Block
235 Patients Enrolled for Left Bundle Branch Block
Brett Atwater, MDPrincipal InvestigatorInova Health Care Services
4 Previous Clinical Trials
658 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.You have previously had a tricuspid valve replaced with a mechanical one.I have a serious heart condition, such as thick heart walls or amyloidosis.I have severe high blood pressure in the lungs.I have had long episodes of atrial fibrillation recently.I have a severe heart valve problem.I expect to start or adjust heart failure medications during the study.I have heart failure but can still walk, or I've been hospitalized for it before.I am 18 years old or older.You need to have clear heart images for the study.I am on a stable heart failure medication plan.Your heart's pumping function is above 35% based on a special heart ultrasound.I am willing and able to follow all study rules and attend all appointments.You have a specific type of heart rhythm issue called Strict LBBB.
Research Study Groups:
This trial has the following groups:- Group 1: Sequence 1
- Group 2: Sequence 2
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.
Are there still opportunities for individuals to be involved in this research?
"The information presented on clinicaltrials.gov reveals that this study is no longer actively recruiting participants; the trial initially commenced on December 23rd 2022 and was updated for the last time on December 7th 2022. However, there are currently over 700 other medical studies looking to enrol patients in need of treatment."
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