Clinical Trials
The OPTIMIZER INTEGRA CCM-D System is an implantable cardiac device system that combines cardiac contractility modulation, also known as CCM™, and implantable cardioverter defibrillator (ICD) modules into one device. CCM-D is also known as a “Cardiac Contractility Modulation – Defibrillator”
- Patient is aged 18 years or older
- Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure
- Patient has HFrEF (LVEF ≤40%)
- Patient is on GDMT for heart failure
- Patient has a Class I or Class II indication for an ICD
- Patient has a reasonable expectation of meaningful survival of > 1 year
- Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred
- Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location
The purpose of this study is to test the comparative effectiveness of His/LBBP in relation to patient centered outcomes (QoL, physical activity, HF hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care BiVP in patients with HF.
Please reach out to the study team for additional details.
- Men and women 18 years of age or older
- A LVEF ≤ 50% within 6 months prior to enrollment
- Resting QRS duration ≥ 130 ms as evidenced by a historical 12-lead ECG prior to enrollment OR Anticipated right ventricular pacing > 40% OR Device in place with right ventricular pacing > 40%
- Are optimized on HF guideline directed medical therapy according to current HF published guidelines
EXCLUSION CRITERIA:
- Women who are pregnant, lactating, or plan to become pregnant
- Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the next three (3) months
- Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment
- Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment
- Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis)
- Participants with known Chagas disease, cardiac sarcoidosis or amyloidosis
- Expected to receive left ventricular assist device or heart transplantation within 6 months
- Participants with severe valvular disease (e.g., aortic stenosis)
- Have a life expectancy of less than 12 months
- Participants with irreversible brain damage from preexisting cerebral disease
- Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine
- Participants participating in any other interventional cardiovascular clinical trial
- Participants who would be unable to return for follow-up visits due to the distance from the clinic
- Participants who do not anticipate being a resident of the area for the scheduled duration of the trial
- Participants who had any prior unsuccessful attempt at implantation of biventricular
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group, event-driven, superiority, group sequential study to evaluate the efficacy and safety of milvexian in participants enrolled within 7 days of an ACS.
Please reach out to the study team for additional details:
- ≥18 years of age
- Participants must have an index event that meets all criteria within 7 days prior to randomization
- A female participant must not be pregnant, breastfeeding, or planning to become pregnant
- Willing and able to adhere to the lifestyle restrictions
The purpose of the PSR platform is to provide continuing evaluation and periodic reporting of safety and effectiveness of market-released products for their intended use.
Inclusion Criteria
- Patient within enrollment window of therapy received at the time of their initial PSR platform enrollment, or meets criteria for retrospective enrollment
Exclusion Criteria
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
- To find the causes of heart damage in people with open arteries using images of the heart arteries (called optical coherence tomography or OCT) and the heart itself (called magnetic resonance imaging or MRI). By “open arteries”, we mean arteries that are less than halfway blocked.
- To find out what blood markers can tell us about the reasons for heart events, and whether stress is related to heart events.
Inclusion / Exclusion Criteria
- Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms
- Age ≥ 21 years
Exclusion Criteria
- History of known obstructive CAD at angiography, including history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- Recent use of vasospastic agents, such as cocaine, triptans, or ergot alkaloids (≤1 month)
- Pregnancy
The purpose of this research is to evaluate the safety of long-term use of the OPTIMIZER Smart and CCM therapy. The PAS will also evaluate the effects of CCM therapy on your quality of life and heart failure symptoms, as well as your heart’s ability to pump effectively (echo) and some potential blood related chemical changes.
Inclusion Criteria
- Male or non-pregnant female, aged 18 or older
- NYHA Class III heart failure symptoms
Exclusion Criteria
- Infiltrative or inflammatory cardiomyopathy (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, Fabry disease, cardiac tumor)
- Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days prior to implant
- IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant, including continuous IV inotrope therapy
- Myocardial infarction within 90 days prior to implant
- Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days prior to implant
- Prior heart transplant or ventricular assist device
- Mechanical tricuspid valve
- Receiving cardiac resynchronization therapy (CRT) or has a Class I indication for CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
- Currently on dialysis
- Currently undergoing treatment for cancer
Post-approval study for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and who are eligible for treatment using the ENROUTE TSS and the ENROUTE Transcarotid NPS.
- Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis: Symptomatic: ≥70% stenosis of the common or internal carotid artery by ultrasound or ≥50% stenosis of the common or internal carotid artery by angiogram OR Asymptomatic: ≥70% stenosis of the common or internal carotid artery by ultrasound or ≥60% stenosis of the common or internal carotid artery by angiogram.
- Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System (refer to IFU for requirements).
- Patient is ≥18 and older.
The Nectero EAST® System is indicated for a locally delivered, single-dose endovascular treatment of infrarenal abdominal aortic aneurysms with a maximum diameter of 3.5 cm to 5.0 cm.
1. Males and females ≥21 years of age. Females must be of nonchildbearing potential (menopause or sterilization).
2. Subject understands the purpose of the trial, agrees to voluntarily participate in the trial, signs the informed consent and is willing to complete the follow-up according to the requirements of the protocol.
3. Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
4. Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
5. Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm.
6. Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters, including severe infrarenal neck angulation.
7. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
8. Subject has > two-year life expectancy.
9. Subject is able and willing to comply with all required follow-up clinic visits including CT scans.