N/A
N=128
Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds
Heart Failure · Ventricular Arrythmias
Bottom Line
View on ClinicalTrials.gov: NCT00746356 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Percentage of Participants Free of System-related Complications at 3-months Post Implant — 93.6 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Testing of the autocapture features of the device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Free of System-related Complications at 3-months Post Implant |
93.6 | — |
| PRIMARY Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test |
0.743; 0.737 | <0.0001 sig |
| PRIMARY Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test |
0.809; 0.862 | 0.0001 sig |
| PRIMARY Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test |
0.739; 0.794 | 0.0001 sig |
| PRIMARY Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test |
1.458; 1.456 | 0.0001 sig |
Summary
This study is a prospective, non-randomized, multi-center clinical trial that will assess the safety and effectiveness of investigational models of the Promote™ RF CRT-D and Current™ RF ICD devices. These new ICD and CRT-D devices have new features that allow the device to periodically check how much energy is needed to pace a patient's heart and to automatically adjust the amount of energy used to pace the heart.
Eligibility Criteria
Inclusion Criteria
- Have an approved indication, as outlined by American Heart Association/Heart Rhythm Society (AHA/HRS) guidelines, for implantation of an ICD or CRT-D for the treatment of life-threatening ventricular tachyarrhythmia(s) or heart failure, or undergo revision of their ICD or CRT-D system to replace the pulse generator.
- Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Exclusion Criteria
- Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months.
- Have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA), Stent or Coronary Artery Bypass Graft(CABG)) within 40 days of enrollment.
- Have had a recent cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment.
- Are allergic to dexamethasone sodium phosphate (DSP).
- Be currently participating in a clinical investigation that includes an active treatment arm.
- Be pregnant or are planning for pregnancy within 6 months following enrollment.
- Have a life expectancy of less than 6 months.
- Be less than 18 years of age.
Data sourced from ClinicalTrials.gov (NCT00746356). 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.