N/A
Completed N=83
ConsultaTM CRT-D Clinical Evaluation Study
Tachyarrhythmias · Heart Failure · Ventricular Dysfunction
Source: ClinicalTrials.gov NCT00526162 ↗
Enrolled (actual)
83
Serious AEs
22.5%
Results posted
Jun 2009
Primary outcomePrimary: Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. — 100 percentage of patients — p=<0.03
Summary
The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. |
100 | <0.03 sig |
| SECONDARY Adverse Events |
70 | — |
| SECONDARY System Performance Assessed by Holter Records |
20 | — |
| SECONDARY System Performance Assessed by Save to Disk Files |
94 | — |
| SECONDARY System Performance Assessed by Technical Observations |
3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have an indication for a defibrillator.
- Patients who are optimally treated with medication.
- Patients who are New York Heart Association (NYHA) Class III or IV
Exclusion Criteria
- Patients with a life expectancy less than the duration of the study.
- Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.
- Patients with mechanical tricuspid heart valves.
Data sourced from ClinicalTrials.gov (NCT00526162). 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.