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Device
Revivent TC System for Heart Failure
N/A
Waitlist Available
Led By Andrew S Wechsler, MD
Research Sponsored by BioVentrix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
LV Aneurysm/Scar Location: Defined as a scar involving septum and/or anterior, apical or anterolateral regions of the left ventricle as evidenced by cardiac imaging and referred for surgical management
Suffering from heart failure symptoms as defined by NYHA Classification > 2 not responsive to medical therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test a new heart device on 126 patients to see if it is better than the current standard treatment. 84 patients will get the new device and 42 will get the standard treatment.
Who is the study for?
This trial is for adults over 18 with heart failure symptoms not improved by medication, left ventricular ejection fraction under 45%, and specific types of LV aneurysm or scar. They must be on standard heart failure therapy, able to do a walk test and questionnaire, not pregnant nor planning pregnancy within a year, and without severe arrhythmias or other major health issues.Check my eligibility
What is being tested?
The BioVentrix Revivent TC System is being tested in this study against active control. The trial will enroll 126 patients; two-thirds will receive the device treatment while one-third are controls. It's designed to see how well the device helps improve heart function compared to current treatments.See study design
What are the potential side effects?
Potential side effects may include complications from implanting the device such as infection risk at the site of surgery, bleeding, blood clots leading to stroke or other problems, irregular heartbeats (arrhythmias), and possible negative reactions to materials in the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart has a scar in specific areas and I am referred for surgery.
Select...
My heart failure symptoms are severe and not improving with medication.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiac Surgery procedures
Cardiac Tamponade
Secondary outcome measures
The rate of re-hospitalization and improvement of HF Symptoms in patients treated with the test device compared to patients who are maintained on Guideline Directed Medical Therapy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Treatment with the Revivent TC System
Group II: Control PoolActive Control1 Intervention
Treatment with Guideline Directed Medical Therapy for Heart Failure Symptoms Only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Revivent TC
2015
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
BioVentrixLead Sponsor
6 Previous Clinical Trials
249 Total Patients Enrolled
Andrew S Wechsler, MDPrincipal InvestigatorDrexel University College of Medicine
Gregg W Stone, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
15 Previous Clinical Trials
21,147 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's left ventricle is too big when it squeezes.I cannot take blood thinners due to health reasons or other issues.I have had open heart surgery or significant inflammation of the heart lining.If you had a certain type of heart treatment within the past 60 days, you cannot join the study.The doctor at the study site thinks you need heart surgery to improve blood flow to your heart.I do not have another serious illness that could cause death within a year, nor do I have cancer that is not in remission.My heart has a scar in specific areas and I am referred for surgery.I have not had a heart attack in the last 90 days.I have had or am waiting for an organ transplant (not heart).I have heart valve disease that may need surgery.Your heart is healthy in areas away from where the scar tissue will be.My kidney function is low with high creatinine or low GFR.I have not had a stroke, brain bleed, or serious brain condition in the last 6 months.My heart failure symptoms are severe and not improving with medication.Your heart's ventricle wall has calcium buildup in the area where the anchor implants are supposed to go, as confirmed by heart imaging.I have a blood clot or mass in my heart that hasn't been treated with blood thinners.Your heart's pumping ability is less than 45%.You have a pacemaker with leads in a specific part of the heart that might cause problems during the study.You are allergic to the materials used in the medical device.You have a specific type of heart condition called LV aneurysm or scar.I am a woman able to have children and I do not plan to become pregnant for at least a year.My heart valve leak is more than moderate due to a functional issue or muscle rupture.My heart's pulmonary artery pressure is high, or I have cor pulmonale.I am following the recommended treatment plan for my condition.You have a serious irregular heartbeat in the lower chambers of your heart.I am 18 years old or older.I have completed a 6-minute walk test and a heart failure questionnaire.I've had surgery or radiation on my right neck that may affect catheter placement.
Research Study Groups:
This trial has the following groups:- Group 1: Control Pool
- Group 2: Treatment
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 any patients presently being enrolled in this trial?
"That is accurate. The information available on clinicaltrials.gov demonstrates that this trial is recruiting patients. The study was originally posted on 8/29/2017, and the most recent update was on 3/10/2021. They are looking for 126 people to participate at 26 different sites."
Answered by AI
Are there any medical conditions which would disqualify a person from being a test subject in this research?
"This trial is currently looking for 126 patients that suffer from ventricular dysfunction and are between the ages of 18 and 100. Eligible candidates must meet the following requirements: Be over 18 years old, have an aneurysm or scar in the left ventricle, have viable myocardium in regions remote from the exclusion area, have an ejection fraction of less than 45%, have a left ventricular end-systolic volume index of 50 mL/m2 or more, suffer from heart failure symptoms that are unresponsive to medical therapy, have completed the 6 Minute Walk Test and MLHF Quality of Life Questionnaire, be"
Answered by AI
Is there an age limit for those who can participate in this research?
"According to the inclusion criteria published for this trial, eligible participants must be between 18-100 years of age. There are 4 other trials for patients under 18 and 34 for patients 65 and older."
Answered by AI
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