CompletedNot Applicable

ConsultaTM CRT-D Clinical Evaluation Study

Germany83 participantsStarted 2007-10

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.

Timeframe: 1 month

Trial details

NCT IDNCT00526162

SponsorMedtronic Cardiac Rhythm and Heart Failure

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01

Results submitted2009-02-06

View on ClinicalTrials.gov More Tachyarrhythmias trials