ConsultaTM CRT-D Clinical Evaluation Study

NCT00526162 | Completed Results

• 1 other identifier: 112
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Tachyarrhythmias; Heart Failure; Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adverse Events

  1 month

• System Performance Assessed by Holter Records

  1 month follow-up

• System Performance Assessed by Save to Disk Files

  1 month follow-up

• System Performance Assessed by Technical Observations

  1 month follow-up

Study Arms (1)

Implantation of Consulta CRT-D

EXPERIMENTAL

Patients have an implant attempt with a Bi-ventricular Implantable Cardioverter Defibrillator

Device: Bi-ventricular Implantable Cardioverter Defibrillator

Interventions

Bi-ventricular Implantable Cardioverter Defibrillator DEVICE

Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator

Also known as: ConsultaTM

Implantation of Consulta CRT-D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Hospital

Bonn, Germany

Location

Related Publications (1)

• 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.

  PMID: 20231152 DERIVED

MeSH Terms

Conditions

Tachycardia; Heart Failure; Ventricular Dysfunction

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: CRDM Core Clinical Organization
• Organization: Medtronic CRDM

jamie.l.reynolds@medtronic.com

800-328-2518

Study Officials

• Consulta Clinical Study Team

  Medtronic Cardiac Rhythm and Heart Failure

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 2, 2025
• Results First Posted: June 10, 2009

Record last verified: 2019-03

Locations

DE (1)