Quality Awards
Clinical Trials
Deliver Insight in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World (Discover-HCM): United States Prospective Registry Study.
Willing and able to provide written informed consent form (ICF) and any required privacy authorization prior to the initiation of study procedures.
a. Diagnosis of obstructive HCM consistent with 2020 American Health Association/American College of Cardiology (AHA/ACC) guidelines.
b. Obstructive HCM is defined clinically by the presence of increased LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of HCM) in a non[1]dilated ventricular chamber that is not solely explained by abnormal loading conditions (eg, another cardiac or systemic disease) and peak LVOT gradient of ≥ 30 mmHg at rest or with provocation.
Receiving BBs, non-DHP CCBs, disopyramide, and/or mavacamten (once available) as part of routine clinical care; or currently receiving no treatment due to intolerance or failure of prior treatment (eg, BBs, non-DHP CCBs, or disopyramide) for obstructive HCM.
DEFINE AFib is a prospective, observational, post-market clinical study administered to patients via the Medtronic Discovery app platform. The Study App is designed to easily collect data using an iPhone® and is built using the Apple® ResearchKit® framework. Interested participants will be screened through the Medtronic Discovery app and those eligible will complete an app-based informed consent. Participants will receive health-focused and quality of life surveys at variable timepoints. DEFINE AFib will measure healthcare interactions using administered surveys to identify said interactions. The Medtronic Discovery app will provide participants with a summary of their ICM data. Participants will be followed up to 5 years or to the end of their ICM service life.
Inclusion Criteria
Patients with a LINQ ICM who have a self-reported history of AF and who have received an ICM for the following device-logged indications, categorized into the following discrete groups:
- Stroke: Cryptogenic stroke indication
- AF management: AF management and post-ablation management indications
- Suspected AF: Suspected AF and palpitations indications
- Individual Access and ability to use an Apple iPhone® compatible with Medtronic's research app (iOS® v. 13.X or higher)
- Patient is 22 years of age or older
- Located in the United States, with CareLink managed through servers located in United States (50 states or District of Columbia)
- Valid email address from self-report at enrollment
- Patient must be able to read and write in English
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.
