BMS DISCOVER REGISTRY
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 nondilated 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.
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
Medtronic Product Surveillance Registry (PSR)
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.
- Patient within enrollment window of therapy received at the time of their initial PSR platform enrollment, or meets criteria for retrospective enrollment
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
NYU Women’s Heart Attack Research Program (NYU HARP)
- 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
- 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)
OPTIMIZER SMART POST-APPROVAL STUDY
A Prospective, Multi-center, Non-randomized, Single Arm Open Label Study of 620 Subjects Receiving the OPTIMIZER Smart With CCM Therapy as Standard of Care
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.
- Male or non-pregnant female, aged 18 or older
- NYHA Class III heart failure symptoms
- 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
Left Atrial Posterior Wall Isolation in Conjunction with Pulmonary Vein Isolation Using the Cryoballon for Treatment of Persistent Atrial FibrilLation Trial (PIVoTAL-IDE Trial)
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous component will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison to PVI alone. The investigator hypothesizes that the combination of PVI + PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation.
- Consistent with the current definitions, all patients with AFp must exhibit an episode of continuous AF that is sustained >7 days.
- Patients must have symptomatic AFp refractory or intolerant to at least one class I, II, III or IV antiarrhythmic drug
- Males and females with an age <18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted
- Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months
- Patients with a history of hypertrophic cardiomyopathy
- Patients with cardiomyopathy and a left ventricular ejection fraction <40%
- Congestive heart failure, class IV
- Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure
- History of left-sided left atrial ablation (catheter or surgically-based)
SRM-2022-01 SILK ROAD-ROADSTER
POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in STANDARD RISK PATIENTS with SIGNIFICANT CAROTID ARTERY DISEASE
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.