Study: NCT02985268

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: MitraClip
Description: The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus \[degenerative MR\] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: MitraClip
Description: The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus \[degenerative MR\] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Optimal Medical Therapy
Description: Optimal medical therapy administered as per the Guideline Direct Medical Therapy (GDMT) as defined in the 2013 ACCF/AHA Heart Failure Guidelines with maximum tolerated doses of an ACE-inhibitor or Angiotensin Receptor Blocker (ARB) and beta-blocker

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Optimal Medical Therapy
Description: Optimal medical therapy administered as per the Guideline Direct Medical Therapy (GDMT) as defined in the 2013 ACCF/AHA Heart Failure Guidelines with maximum tolerated doses of an ACE-inhibitor or Angiotensin Receptor Blocker (ARB) and beta-blocker

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Optimal Medical Therapy
Description: Optimal medical therapy administered as per the Guideline Direct Medical Therapy (GDMT) as defined in the 2013 ACCF/AHA Heart Failure Guidelines with maximum tolerated doses of an ACE-inhibitor or Angiotensin Receptor Blocker (ARB) and beta-blocker

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Optimal Medical Therapy
Description: Optimal medical therapy administered as per the Guideline Direct Medical Therapy (GDMT) as defined in the 2013 ACCF/AHA Heart Failure Guidelines with maximum tolerated doses of an ACE-inhibitor or Angiotensin Receptor Blocker (ARB) and beta-blocker

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: CRT-D
Description: Cardiac Resynchronization Therapy with defibrillation therapy devices will be implanted according to the Heart Rhythm Society Guidelines for implanted devices.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: CRT-D
Description: Cardiac Resynchronization Therapy with defibrillation therapy devices will be implanted according to the Heart Rhythm Society Guidelines for implanted devices.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: CRT-D
Description: Cardiac Resynchronization Therapy with defibrillation therapy devices will be implanted according to the Heart Rhythm Society Guidelines for implanted devices.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: CRT-D
Description: Cardiac Resynchronization Therapy with defibrillation therapy devices will be implanted according to the Heart Rhythm Society Guidelines for implanted devices.