ALternate Site Cardiac ReSYNChronization (ALSYNC) Study

ALternate Site Cardiac ReSYNChronization Study

The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective, non-randomized, multi-national clinical investigation.

The purpose of this clinical investigation is to evaluate the safety and performance of the investigational atrial transseptal endocardial LV lead delivery system and the implant procedure for delivering the SelectSecure® Model 3830 lead into the Left Ventricle via a superior approach, and to evaluate the performance of the SelectSecure® Model 3830 lead in the Left Ventricle.

Cardiac resynchronization therapy (CRT) reduces mortality and the risk of heart failure decompensation and improves quality of life in indicated patients. However, many do not benefit due to failure to deliver the left ventricular (LV) lead via coronary sinus (5-10%) or lack of symptomatic improvement (30-40%).

The purpose of the ALSYNC Study was to evaluate the feasibility and safety of LV endocardial (LVE) pacing using a Model 3830 lead implanted by a novel pectoral atrial transseptal lead delivery system.

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 (International Normalized Ratio (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 atrial septum defect (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