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Completed

NCT Number: NCT00526162

ConsultaTM CRT-D Clinical Evaluation Study

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).

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Key information

Conditions

Tachyarrhythmias Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Ventricular Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital

Bonn, Germany

About this study

The Consulta CRT-D is an investigational bi-ventricular device that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation and cardiac resynchronization therapy.

The study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 18 centers.

To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Consulta device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bi-ventricular Implantable Cardioverter Defibrillator

Device

Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator

Other names: ConsultaTM

Primary outcomes

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

    Time frame: 1 month

    Percentage of subjects without an unanticipated serious adverse device effects at 1-month post implant.Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis.

Secondary outcomes

  1. Adverse Events

    Time frame: 1 month

    Number of Adverse Events reported in the implanted subjects.

  2. System Performance Assessed by Holter Records

    Time frame: 1 month follow-up

    The first 20 digital Holter records that were successfully collected in the total of 80 implanted subjects were analysed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.

  3. System Performance Assessed by Save to Disk Files

    Time frame: 1 month follow-up

    94 Save to Disk files were reviewed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.

  4. System Performance Assessed by Technical Observations

    Time frame: 1 month follow-up

    Reported technical observations will be reviewed to determine if there are any device performance issues.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Clinical Study to Evaluate System Safety and Clinical Performance of the ConsultaTM CRT-D Device

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 10, 2007
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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