Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Subjects were recruited if their healthcare provider decided that they needed treatment with a special Internal Cardiac Defibrillator (ICD) called a biventricular ICD. The investigators did this study to see if part of the nerve organ, called the sympathetic nervous system, may be responsible for the improvement seen in patients that receive biventricular pacing. The investigators had three ways to measure sympathetic nervous activity: 1) by using a special blood sample, 2) by monitoring heart rhythm, and 3) by performing a special heart scan.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: GE Healthcare
• Treatments: 3-Iodobenzylguanidine; Iodine

Criteria

Inclusion criteria: Indications for Biv-ICD implantation

1. Chronic moderate to severe congestive heart failure (CHF) (NYHA class II or IV)

2. Left ventricular ejection fraction (LVEF) of 35% or less

3. Q wave, R wave and S wave (QRS complex) QRS duration of 120 ms or more

4. On optimized anti-heart failure medical regimen

5. Meet one of the following indications for ICD

• Survivors of cardiac arrest due to ventricular fibrillation (VF) or ventricular tachycardia (VT) or spontaneous sustained VT

• Nonsustained VT with coronary disease, prior myocardial infarction, LVEF 35% or less, and inducible VF or sustained VT at electrophysiologic study

• LVEF of 30% or less with severe coronary artery disease

Exclusion criteria:

1. Patient condition is unstable

2. Patient is unable to give informed consent

3. Not feasible for patient to be followed at Mayo Clinic

4. Female in pregnancy and breast feeding