'Effect of CRT on Defibrillation Threshold Estimates' Study

Completed · Phase 4

Conditions studied: Sudden Cardiac Death

In brief

The purpose of this prospective study is to evaluate the effect of cardiac resynchronization therapy (CRT) on the defibrillation threshold (DFT) estimates in cardiac resynchronization therapy defibrillators (CRT-D) patients. The hypothesis of the study is that defibrillation threshold (DFT) will decrease with 6 months of cardiac resynchronization therapy (CRT).

Key facts

Study ID

NCT00626093

Run by

Abbott Medical Devices

People needed

77

Starts

2008-01-01

Expected to finish

2010-04-01

Last updated by the study team

2019-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient meets standard indications for a Cardiac Resynchronization Therapy - Defibrillator (CRT-D).
• Patient will be implanted with an FDA approved St Jude Medical (SJM) Cardiac Resynchronization Therapy - Defibrillator (CRT-D) and compatible defibrillation lead system.
• Patient is able to tolerate defibrillation threshold (DFT) testing.
• Patient is geographically stable and willing to comply with the required follow-up schedule.
• Patient has a life expectancy of greater than 6 months from the time of implant.
• Patient has stable heart failure (HF) medications at least one month prior to enrollment.

You may not qualify if…

• Inability to successfully implant an intravascular lead Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device. (i.e. exclude epicardial leads).
• Patient is getting his Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device replaced.
• Inability to successfully obtain the defibrillation threshold (DFT) at implant.
• Currently participating in a clinical trial that includes an active treatment arm or another data collection registry.
• Recent (within 24 hours) administration of Nesiritide™.
• Patient is on amiodarone (other antiarrhythmic agents known to affect defibrillation thresholds - DFTs) at the time of enrollment.
• Patient is pregnant.
• Patient is less than 18 years old.

Where it is running

• Pacific Heart Institute — Santa Monica, California, United States
• Penrose Hospital — Colorado Springs, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.