ConsultaTM CRT-D Clinical Evaluation Study

This study has been completed.
Information provided by:
Medtronic Bakken Research Center Identifier:
First received: September 6, 2007
Last updated: April 21, 2009
Last verified: April 2009

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 Intervention
Heart Failure
Ventricular Dysfunction
Device: Bi-ventricular Implantable Cardioverter Defibrillator

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate System Safety and Clinical Performance of the ConsultaTM CRT-D Device

Resource links provided by NLM:

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Describe System Performance [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Bi-ventricular Implantable Cardioverter Defibrillator
Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator
Other Name: ConsultaTM

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00526162

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

No publications provided by Medtronic Bakken Research Center

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00526162     History of Changes
Other Study ID Numbers: 112
Study First Received: September 6, 2007
Results First Received: February 6, 2009
Last Updated: April 21, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Denmark: Danish Medicines Agency
Norway: Directorate of Health
Sweden: Medical Products Agency
Netherlands: Dutch Health Care Inspectorate
Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Ministry for Health and Women
Switzerland: Swissmedic
Israel: Ministry of Health

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes processed this record on April 17, 2014