ConsultaTM CRT-D Clinical Evaluation Study

This study has been completed.
Sponsor:
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00526162
First received: September 6, 2007
Last updated: April 21, 2009
Last verified: April 2009
  Purpose

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
Tachyarrhythmias
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526162

Locations
Germany
Hospital
City, Germany
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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
Tachycardia
Ventricular Dysfunction
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014