NCT00526162

ConsultaTM CRT-D Clinical Evaluation Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Tachyarrhythmias
• Heart Failure
• Ventricular Dysfunction

Interventions

Type	Name	Description
DEVICE	Bi-ventricular Implantable Cardioverter Defibrillator	Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-01-01
• Completion: 2008-10-01
• First posted: 2007-09-10
• Last updated: 2025-07-02
• Results posted: 2009-06-10

Locations

1 site across 1 country: Germany