ConsultaTM CRT-D Clinical Evaluation Study

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

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure; Ventricular Dysfunction; Tachyarrhythmias
• Intervention / Treatment: Device: Bi-ventricular Implantable Cardioverter Defibrillator

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
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany
    • Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who have an indication for a defibrillator.
• Patients who are optimally treated with medication.
• Patients who are New York Heart Association (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implantation of Consulta CRT-D; Patients have an implant attempt with a Bi-ventricular Implantable Cardioverter Defibrillator	Device: Bi-ventricular Implantable Cardioverter Defibrillator; Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator; Other Names: ConsultaTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.	Percentage of subjects without an unanticipated serious adverse device effects at 1-month post implant.Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Performance Assessed by Technical Observations	Reported technical observations will be reviewed to determine if there are any device performance issues.	1 month follow-up
Adverse Events	Number of Adverse Events reported in the implanted subjects.	1 month
System Performance Assessed by Holter Records	The first 20 digital Holter records that were successfully collected in the total of 80 implanted subjects were analysed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.	1 month follow-up
System Performance Assessed by Save to Disk Files	94 Save to Disk files were reviewed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.	1 month follow-up

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Chair: Consulta Clinical Study Team, Medtronic Cardiac Rhythm and Heart Failure

Publications and helpful links

General Publications

• 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. doi: 10.1093/europace/euq053. Epub 2010 Mar 14.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: September 6, 2007
• First Submitted That Met QC Criteria: September 6, 2007
• First Posted (Estimated): September 10, 2007

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Ventricular Dysfunction
• Other Study ID Numbers: 112