Clinical Trials

Primary Inclusion Criteria:

• Subject has severe (Grade III or greater per the ASE criteria, which includes severitygrades of 3+ and 4+) primary MR (mixed etiology is acceptable provided theprincipal mechanism of action is a degenerative mitral valve) as assessed bythe ECL.

• Subject is at least 75 years of age

Primary Inclusion Criteria:

• Patients ≥ 18 years old
• Patients with paroxysmal or persistent AF undergoing routine pulmonary vein isolation (PVI)
• Patients undergoing a cardiac MRI prior to AF ablation

Primary Exclusion Criteria:

• Contraindication to MRI
• Abnormal renal function (eGFR < 60 mL/min/1.73 m2)

• Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
• Bioprosthetic valve size suitable for SAPIEN X4 THV based on computed tomography angiography (CTA) analysis
• NYHA functional class ≥ II

• Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab
• Patient is symptomatic despite medical therapy
• The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention

Patient will undergo treatment with a Thoraflex Hybrid device

• Ascending Aortic pathologies warranting surgical repair
• Anatomic compatibility with the ASG device based on Gore Imaging Sciences review
• Must be considered high-risk for open surgical repair

Listed for heart transplantation

• Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
• Bioprosthetic valve size suitable for SAPIEN X4/X4S THV based on computed tomography angiography (CTA) analysis
• NYHA functional class ≥ II

• De novo Type A aortic dissection (≤30 days from symptom onset to index endovascular procedure) compatible with the treatment requirements of the ASG device
• Primarily intended to be treated by placement of the ASG device in the ascending aorta. Distal adjunctive procedures not in contact with the ASG device may be performed during the index endovascular procedure at the discretion of the Investigator
• Anatomic compatibility of the ascending aorta required for implanting the ASG device

• Moderate-severe or severe MR (grade 3+ to 4+); either degenerative MR (DMR) or functional (FMR)
• Symptomatic MR (i.e., NYHA Class ≥ II) despite optimal or maximally tolerated guideline-directed medical therapy (GDMT)
• Deemed to be at elevated risk for conventional mitral valve surgery by the heart team

• Patient has one of the following indications for open surgery based on computed tomography angiography (CTA) completed within 90 days of informed consent
  • Acute, subacute, or chronic dissection that involves the aortic arch and the descending thoracic aorta, with or without involvement of the ascending aorta
  • Aneurysm that involves the aortic arch and the descending thoracic aorta, with or without involvement of the ascending aorta

• Subject is eligible for percutaneous coronary intervention (PCI)
• Target lesion is a de novo lesion located in a native coronary artery and meets at least 1 of the 3 criteria

• Subject has history of documented paroxysmal (AF that is intermittent and terminates within ≤ 7 days of onset) or persistent/long standing persistent atrial fibrillation (AF that is continuous and sustains for > 7 days and requires intervention) within one year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor or telemetry strip from the study hospital or an outside physician
• Subject is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery via sternotomy for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Ascending aortic aneurysms, Atrial Septal Defect (ASD)/Patent Foramen Ovalle (PFO) or Coronary artery bypass procedures
• Left ventricular ejection fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)

All patients with a stoma (independent of diagnosis)

Age 18 or greater

Surgical oncology patient where routine radiologic surveillance for malignancy is planned

Patient accepts participation and gives informed consent