Heart Failure study: OPTIMIZER™ Smart Mini System
Official title Assessment of CCM in HF With Higher Ejection Fraction
ClinicalTrials.gov ID: NCT05064709
What this study is testing
- What it's testing
- This study is testing whether a new heart treatment works well. It also checks how safe it is and what side effects it causes.
- Who it's for
- You may be able to join if you have heart failure with a pumping rate between 40% and 70%.
- What's involved
- You would get a new treatment called Cardiac Contractility Modulation (CCM). This is a therapy that helps the heart muscle squeeze better.
- Time commitment
- The source text does not say how long the study lasts or what visits are needed.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed and dated informed consent form;
- Male or non-pregnant female, 18 years or older;
- Diagnosed with symptomatic heart failure;
- LVEF ≥40 and ≤70% (as assessed by site echo). A historical echo within 60 days of consent may be used for baseline.
- Normal Sinus Rhythm (NSR): NTproBNP (pg/ml) ≥ 150 or BNP (pg/ml) ≥ 50
You likely can't join if
- Resting ventricular rate \ 110 bpm;
- Resting systolic blood pressure \<100 or ≥160 mmHg;
- BMI greater than 46
- Any severe valvular stenotic disease or any severe valvular regurgitation;
- Mechanical tricuspid valve;
- Complex congenital heart disease;
See the full eligibility criteria
- Signed and dated informed consent form;
- Male or non-pregnant female, 18 years or older;
- Diagnosed with symptomatic heart failure;
- LVEF ≥40 and ≤70% (as assessed by site echo). A historical echo within 60 days of consent may be used for baseline. Ultrafiltration should not be performed within 30 days of echo;
- Normal Sinus Rhythm (NSR): NTproBNP (pg/ml) ≥ 150 or BNP (pg/ml) ≥ 50
- Atrial Tachyarrhythmia (AT): NTproBNP (pg/ml) ≥ 450 or BNP (pg/ml) ≥ 150
- Historical natriuretic peptide values within 6 months of consent may be used if subject is in NSR. people in AT on baseline ECG must have natriuretic peptide values collected post-consent.
- Have stable, scheduled oral loop diuretic treatment (not just PRN) for a minimum of 30 days before providing study consent unless there is a documented allergy or intolerance.
- Eligibility for enrollment is maintained for patients on an SGLT2 inhibitor without prescribed concurrent standing loop diuretic therapy if investigators provide instructions for a flexible PRN diuretic regimen (deemed...
- Resting ventricular rate \ 110 bpm;
- Resting systolic blood pressure \<100 or ≥160 mmHg;
- BMI greater than 46
- Any severe valvular stenotic disease or any severe valvular regurgitation;
- Mechanical tricuspid valve;
- Complex congenital heart disease;
- Diagnosis of any of the following conditions that, in the opinion of the investigator, contributes significantly to the primary symptoms of exercise intolerance: angina, significant pulmonary disease, or currently...
- Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
- A KCCQ CCS score higher than 85;
- Infiltrative/restrictive (e.g., amyloidosis, sarcoidosis, hemochromatosis, Fabry, or radiation-induced heart disease), eccentric LV hypertrophy or inflammatory cardiomyopathy as documented in the medical record;
- Unstable angina pectoris within 30 days prior to study consent;
- Receiving cardiac resynchronization therapy (CRT); NOTE: people with active/ongoing cardiac resynchronization therapy (CRT) implanted more than one year ago are eligible for inclusion if they are currently classified as...
- Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
- Myocardial infarction within 90 days prior to study consent;
- Prior heart transplant or ventricular assist device;
- Planning to become pregnant during the study;
- Dialysis (permanent) or GFR \<15 ml/min/1.73m2;
- Participating in another investigational drug or device study that may interfere with the interpretation of study data;
- Currently undergoing active chemotherapeutic and/or radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent;
- Expected lifespan of less than 18 months from time of study consent;
- Unable to follow through study protocol for any reasons (social support, incarceration, mental illness etc.) in the investigator's judgement.
- Insurance denial (after all attempts and appeals have been exhausted, and prior-authorization services utilized, if applicable)
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Mesa, Arizona, United States
- Scottsdale, Arizona, United States
- Tuscon, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- Redwood City, California, United States
- Danbury, Connecticut, United States
- Hartford, Connecticut, United States
- Cutler Bay, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Weston, Florida, United States
- Gainesville, Georgia, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- West Des Moines, Iowa, United States
- Kansas City, Kansas, United States
- Lexington, Kentucky, United States
+ 32 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Mesa, Arizona, United States; Scottsdale, Arizona, United States; Tuscon, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States and 46 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.