Clinical Trials

• Patients ≥ 18 years old
• Patients with paroxysmal or early persistent AF undergoing routine pulmonary vein isolation (PVI)
• Subjects who are scheduled to undergo clinically ordered cardiac MRI for planning of AF ablation

Primary Exclusion Criteria:

• Longstanding persistent AF (continuous AF > 1 year) or AF from a reversible cause
• Previous catheter or surgical ablation for AF
• Contraindication to MRI
• Advanced chronic renal insufficiency (GFR < 30 mL/min/1.73 m2), anemia (hemoglobin < 10 g/dL) or thrombocytopenia (platelet count < 100K/UL)
• History of pulmonary emboli, CVA or TIA (within the past 6 months), atrial clot/thrombus on imaging, or blood clotting/bleeding abnormalities

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

• Completion of a Cytokinetics study investigating CK-3773274. If unable to complete due to circumstances not related to compliance or safety, Medical Monitor may review and determine eligibility.
• LVEF ≥ 55%

• Subject has pre-existing heart failure, with NYHA Class IV prior to the index admission
• Presenting with acute heart failure and meets one of the following criteria:
• Sustained episode of systolic blood pressure ≤90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure
• Or a cardiac index (CI) <2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
• Or required support with an intra-aortic balloon pump

• Acute DeBakey type I dissection based on computed tomography angiography (CTA) and diagnosed ≤14 days from of the index event
• Presence of malperfusion (cerebral, visceral, renal, spinal cord, and/or peripheral)

• Documentation of any of the following clinical criteria:
• CHA2DS2-VASc ≥ 4 with age ≥ 65
• CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP *
• CHA2DS2-VASc = 3 with age ≥ 75
• CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP *
• CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP *
• Significant left atrium enlargement or elevated NT-proBNP

• Ejection Fraction >=45%
• In the hospital setting >24 hours for the management of acute decompensated heart failure (ADHF), or diagnosed with ADHF after being hospitalized for another reason

• Documented history of symptomatic or asymptomatic paroxysmal or persistent AF
• CHA2DS2-VASC score of 1-4 without prior stroke or TIA
• Participant is on a DOAC at time of screening

Diagnosed with oHCM per study criteria by cardiac magnetic resonance imaging (CMR) or echocardiography

• History of heart failure or suspected heart failure
• Scheduled to undergo a right heart catheterization (RHC) procedure
• Willing to wear the CardioTag device during their RHC procedure

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

• Chronic symptomatic heart failure (HF) due to non-valvular and noncongenital left heart disease (LHD)
• on stable medically optimized guideline-directed medical therapy (GDMT) for HFpEF/HFmrEF, for >30 days

Ambulatory with an age of 22-85 years at time of enrollment

Heart Failure with EF ≥ 40% (by TTE within last 3 months)

NYHA Class II or III

• NYHA Functional Classification II or III,
• Elevated NT-proBNP OR BNP with adjusted clinical thresholds (only ONE needed)
• Presence of structural or functional cardiac disease confirmed by echocardiographic evidence of at least one of the following
• (1) Increased LV filling pressures OR
• (2) Left atrial enlargement OR
• (3) LV hypertrophy
• LVEF ≥ 55%
• Established diagnosis of HFpEF consistent with local heart failure guidelines

Diagnosis of ATTR-CM

Medical history of HF

Treatment for HF/ATTR-CM is optimized and symptoms are clinically stable

Documented symptomatic PAF or PersAF

Plans to undergo a PVI catheter ablation procedure due to symptomatic PAF or PersAF

• A screening LVEF between 40% and 65% in the absence of hemodynamically significant and/or severe valvular disease on 2D-TTE, with at least one other documented LVEF measurement between 40% and 65% and within 52 weeks prior to screening as confirmed by echocardiography, radionuclide ventriculogram, cardiac CT, or CMR, AND
• Elevated level of NT-proBNP (≥ 600 pg/mL)
• Documented evidence of paroxysmal (on ≥ 2 occasions ≥ 1 week apart), persistent or permanent atrial fibrillation/flutter by electrocardiogram, Holter, implantable device, or telemetry based event monitoring within the last 5 years

• Is suspected of having cardiac amyloidosis and is undergoing or will undergo a diagnostic evaluation for cardiac amyloidosis (e.g., echocardiography, CMR, bone avid tracer cardiac SPECT, extracardiac or endomyocardial biopsy, etc.). Participants can be enrolled before or during their diagnostic evaluation for cardiac amyloidosis.
• Able to undergo PET/CT imaging as part of the study, including ability to lie supine for approximately 1 hour.