ConsultaTM CRT-D Clinical Evaluation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00526162
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : June 10, 2009
Last Update Posted : June 10, 2009
Information provided by:
Medtronic Bakken Research Center

Brief 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).

Condition or disease Intervention/treatment Phase
Tachyarrhythmias Heart Failure Ventricular Dysfunction Device: Bi-ventricular Implantable Cardioverter Defibrillator Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate System Safety and Clinical Performance of the ConsultaTM CRT-D Device
Study Start Date : October 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Device: Bi-ventricular Implantable Cardioverter Defibrillator
Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator
Other Name: ConsultaTM

Primary Outcome Measures :
  1. Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Describe System Performance [ Time Frame: 1 month ]
  2. Adverse Events [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have an indication for a defibrillator.
  • Patients who are optimally treated with medication.
  • Patients who are 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00526162

City, Germany
Sponsors and Collaborators
Medtronic Bakken Research Center
Study Chair: Consulta Clinical Study Team Medtronic Bakken Research Center

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00526162     History of Changes
Other Study ID Numbers: 112
First Posted: September 10, 2007    Key Record Dates
Results First Posted: June 10, 2009
Last Update Posted: June 10, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes