Phase 4
Completed N=77
'Effect of CRT on Defibrillation Threshold Estimates' Study
Source: ClinicalTrials.gov NCT00626093 ↗Enrolled (actual)
77
Serious AEs
1.3%
Results posted
Jan 2013
Primary outcomePrimary: Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months — 5.6 Volts
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months |
5.6 | — |
| SECONDARY Defibrillation Threshold Difference Obtained in Joules (J) |
0.3 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00626093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.