ALternate Site Cardiac ReSYNChronization (ALSYNC) Study

Inclusion Criteria:

• Cardiac Resynchronization Therapy candidate/recipient with:
• Failed Cardiac Resynchronization Therapy implant or required CRT replacement without viable access to Coronary sinus or,
• Sub-optimal Coronary sinus anatomy per investigator discretion or,
• Worsened or unchanged clinical status after Cardiac Resynchronization Therapy implant
• Patients able and willing to take optimal Vitamin K antagonist therapy (INR of 2-4)
• Patients willing to sign and date the Patient Informed Consent form
• Patients 18 years of age or older
• Patients able and willing to comply with the protocol, and is expected to remain available for follow-up visits

Exclusion Criteria:

• Patients having contraindications to Vitamin K antagonist therapy
• Patients contraindicated for < 100 micrograms beclomethasone dipropionate
• Patients unable to tolerate an urgent thoracotomy
• Documented (previous) ischemic or hemorrhagic stroke
• Patients with known previous atrial septal defect closure, or history of mural thrombus that has not been resolved
• Patients with documented atrial fibrillation AND increased stroke risk as determined by the Congestive Heart Failure, Hypertension, Age(2), Diabetes, Stroke(2), Vascular disease, Age, and Sex Category (CHA2DS2-VASc) Score of equal to or greater than 5
• Patients with unstable angina pectoris or who have had an acute myocardial infarct within the past 30 days
• Patients with known ASD and/or left superior vena cava
• Patient with known internal carotid artery stenosis of greater than 50%
• Patients diagnosed with peripheral artery disease that are expected to undergo stenting within the next three months
• Patients who have had a Coronary artery bypass graft or stent within the past three months
• Patients with history of mitral or aortic valve repair or replacement
• Post heart transplant patients (patients waiting for heart transplant are allowed in the study)
• Patients currently undergoing dialysis treatment
• Patients with ongoing chemotherapy and radiation therapy that may have an effect on cardiac function
• Patients with ongoing Adverse Events from a previous Left Ventricle lead implant attempt
• Patients enrolled in any concurrent drug and/or device study that may confound the results of this study
• Patients who are not expected to survive more than twelve months
• Patients with exclusion criteria required by local law