Heart Failure - Integra-D

Evaluate the device effectiveness in converting induced VF at the time of implantation. The
primary hypothesis of the study is that the Integra CCM D ca n safely and effectively convert induced
VF and spontaneous VT/VF episodes.

Criteria:
Inclusion:

  • Patient is aged 18 years or older
  • Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure8;
    NOTE: Stage C or D criteria of the Universal Definition of Heart Failure include symptoms and or signs caused by a structural and/or functional cardiac abnormality (as determined by an EF of <50%, abnormal cardiac chamber enlargement, E/E' of >15, moderate/severe ventricular hypertrophy or moderate/severe valvular obstructive or regurgitant lesion) and corroborated by at least one of the following:
  • Elevated natriuretic peptide levels:
    Ambulatory Hospitalized/Decompensated
    BNP, pg/mL ≥35 ≥100
    NT-proBNP, pg/mL ≥125 ≥300
  • Objective evidence of cardiogenic pulmonary or systemic congestion by diagnostic modalities, such as imaging (e.g., by chest radiograph or elevated filling pressures by echocardiography) or hemodynamic measurement (e.g., right heart catheterization, pulmonary artery catheter) at rest or with provocation (e.g., exercise).
  • Patient has HFrEF (LVEF ≤40%)
  • Patient is on GDMT for heart failure
  • Patient has a Class I or Class II indication for an ICD
  • Patient has a reasonable expectation of meaningful survival of > 1 year
  • Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred
  • Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location.

Exclusion:

  • Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR
  • Patients who have undergone mitral valve repair or clip within 90 days prior to study consent
  • Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent
  • Prior heart transplant or ventricular assist device
  • Implanted mechanical tricuspid valve
  • PR interval greater than 375ms or advanced AV block
  • In situ S-ICD, pacemaker, or CRT device
  • Indicated for CRT
  • End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer)
    Indicated for permanent bradyarrhythmia pacing
  • Unstable angina pectoris within 30 days prior to study consent
  • Pregnant or planning to become pregnant during the study
  • Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent);
    Note: Registries and other observational studies are acceptable.
  • Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator

Location(s): Hartford Hospital, Midstate, Backus

Contact(s): Jennifer Rossi, 860-972-5311, [email protected]