Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: AV Delay programming through cardiac resynchronization therapy; AV Delay programming through cardiac resynchronization therapy; AV Delay programming through cardiac resynchronization therapy
Intervention description: All subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm.; All subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm.; All subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1060.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Failure; HF; Cardiac Resynchronization Therapy; CRT; Optimization; SmartDelay; Echocardiography; AV Delay

Summary:

      The primary objective of SMART-AV is to assess the effect of SmartDelay for determining
      optimal AV delay timing during CRT compared to both a fixed AV delay and
      echocardiography-determined optimal AV timing chronically over a 6-month period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who meet current indications for a BSC CRT-D device with the SmartDelay
             algorithm

          -  Patients who are willing and capable of undergoing a device implant and participating
             in all testing associated with the SMART-AV Study

          -  Patients who are on optimal and stable pharmacologic therapy

          -  Patients who are expected to be in sinus rhythm at the time of implant

          -  Patients who have a life expectancy of more than 360 days, per physician's discretion

          -  Patients who are geographically stable and willing to comply with the required
             follow-up schedule

          -  Patients who are 18 years of age or above, or of legal age to give informed consent
             specific to state and national law

        Exclusion Criteria:

          -  Patients who are in complete heart block, or who otherwise are unable to tolerate
             pacing at VVI-40 RV for up to 14 days

          -  Patients undergoing an upgrade of a pacemaker or implantable
             cardioverter-defibrillator who are unable to tolerate pacing at VVI-40 RV for up to 14
             days

          -  Patients who have previously received cardiac resynchronization therapy

          -  Patients who are expected to receive a heart transplant or have other cardiac
             surgeries or procedures planned during the course of the study

          -  Patients who currently have or who are likely to receive a tricuspid valve prosthesis

          -  Patients who have a neuromuscular, orthopedic, or other non-cardiac condition that
             prevents normal, unsupported walking

          -  Patients who are pregnant or planning to become pregnant during the study

          -  Patients who are currently enrolled in another investigational study or registry that
             would directly impact the treatment or outcome of the current study