ConsultaTM CRT-D Clinical Evaluation Study - Full Text View

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:

MedlinePlus related topics: Heart Failure Pacemakers and Implantable Defibrillators

U.S. FDA Resources

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

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):

Murgatroyd FD, Helmling E, Lemke B, Eber B, Mewis C, van der Meer-Hensgens J, Chang Y, Khalameizer V, Katz A. Manual vs. automatic capture management in implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. Europace. 2010 Jun;12(6):811-6. Epub 2010 Mar 14.

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
Heart Diseases

Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013