Status:
TERMINATED
Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
GE Healthcare
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
The Specific Aim #1 of this study is to assess, with 123iodine metaiodobenzylguanidine (123I-MIBG imaging), whether cardiac resynchronization therapy (CRT) rebalances and improves the integrity and fu...
Eligibility Criteria
Inclusion
- Inclusion criteria: Indications for Biv-ICD implantation
- Chronic moderate to severe congestive heart failure (CHF) (NYHA class II or IV)
- Left ventricular ejection fraction (LVEF) of 35% or less
- Q wave, R wave and S wave (QRS complex) QRS duration of 120 ms or more
- On optimized anti-heart failure medical regimen
- 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:
- Patient condition is unstable
- Patient is unable to give informed consent
- Not feasible for patient to be followed at Mayo Clinic
- Female in pregnancy and breast feeding
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01522378
Start Date
February 1 2012
End Date
February 1 2016
Last Update
April 26 2017
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905