Inclusion Criteria:
Patients with heart failure meeting standard criteria for CRT based upon the current European Society of Cardiology / European Heart Rhythm Association (ESC/EHRA) guidelines and meeting criteria in one of these categorizations:
Untreated by conventional CRT:
This includes:
* Patients that have had an attempted but failed CS lead implant due to such complications as venous occlusion, difficult CS access or anatomy, poor lead stability or previous CS repositioning procedures.
* Patients with a previously implanted CS lead that is programmed off due to such complications as high pacing threshold, non-capture, phrenic nerve stimulation, lead failure, lead dislodgement, or other justifications due to lead issues documented by the prescribing physician.
Non-responder to conventional CRT
This includes:
• Patients with a previously implanted CRT device who based on prescribing physician judgment experience no change or worsening of heart failure symptoms or no change or worsening of NYHA functional class after 6 months of CRT treatment.
Upgrade:
This includes:
* Patients that have a relative contraindication for a CS lead implant such as difficult subclavian access, venous thrombosis, venous occlusion, risk of lead dislodgment, or other justification documented by the prescribing physician.
* Patients that have a relative contraindication for revising an implanted device to a CRT device such as previous pocket erosion, previous pocket infection, previous explantations, or other justifications documented by the prescribing physicians.
* Patients with other justifications based upon the prescribing physician's judgment of risk to reopening the device pocket including consideration for the remaining longevity of the pacemaker/ICD battery.
Exclusion Criteria:
Triple anticoagulation therapy (warfarin, clopidogrel, ASA, or other agents) Stage 4 or 5 renal dysfunction defined as GFR \<30 Grade 4 mitral valve regurgitation Thrombocytopenia (platelet count \<150,000) Non-ambulatory (or unstable) NYHA class 4 Contraindication to heparin Contraindication to both chronic anticoagulants and antiplatelet agents Contraindication to iodinated contrast agents Insufficient acoustic window to the LV as assessed from diagnostic transthoracic echocardiography Left atrial or left ventricular thrombus Attempted implant of a Pacemaker, ICD, or CRT device within 3 days Life expectancy \< 12 months Chronic hemodialysis Myocardial infarction within one month Major cardiac surgery within one month Incompatible electrical stimulation therapy devices, for example transcutaneous electrical nerve stimulation (TENS) or other neurological stimulation devices Exposure to magnetic resonance imaging (MRI) Use of diathermy Use of therapeutic ultrasound Use of echocardiography imaging using vascular, intracardiac, Doppler, and trans-esophageal probes and systems Use of ionizing radiation treatments
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