Quartet Lead and Resynchronization Therapy Options

NCT01295840 | Completed Phase 4 Results

• 1 other identifier: CR 10-046-SP-HF
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Clinical Trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new Quartet® left ventricular lead, as a result of its four electrodes, with respect to the configurations offered by a standard bipolar lead. Furthermore, the optimal stimulation configuration will be determined from a comparison with traditional configurations.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode.

  Enrollment visit (in the seven days after implantation of the device)

Secondary Outcomes (10)

• Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors

  At enrollment

• Cardiac Output (CO) With Different Configurations at Enrollment

  Enrollment visit (in the seven days after implantation of the device)

• Capture Threshold

  Enrollment visit (in the seven days after implantation of the device)

• Capture Threshold

  6 months post-implant

• Number of Vectors With Phrenic Nerve Stimulation (PNS)

  Enrollment visit (in the seven days after implantation of the device)

Study Arms (1)

CRT therapy

NO INTERVENTION

Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Device: Cardiac Resynchronization Therapy Defibrillator

Interventions

Cardiac Resynchronization Therapy Defibrillator DEVICE

Cardiac Resynchronization Therapy Defibrillator

Also known as: Promote Q. Model, Promote Quadra™., Quartet®: Tetrapolar left ventricular lead. Model 1458Q.

CRT therapy

Eligibility Criteria

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

You may qualify if:

• Patients with a Cardiac resynchronization Therapy Defibrillator device (CRT-D) and a Quartet® quadripolar electrode from St Jude Medical (used in "Single Site Pacing" mode) implanted in the left ventricle.
• Patients who have provided written informed consent
• Patients who are in sinus rhythm.
• Patients older than 18 years of age.

You may not qualify if:

• Patients in atrial fibrillation at the time of the echocardiographic study of the enrollment visit.
• Patients with valvular disease.
• Patients in functional class New York Heart Association (NYHA) IV
• Patients for whom echocardiography images suitable for determining the cardiac output cannot be obtained.
• Patients whose device has been changed/upgraded.
• Pregnant patients.
• Patients who are unable to provide written informed consent

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Hospital Clínico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr Javier Alzueta
• Organization: Hospital Universitario Virgen de la Victoria

jalzueta@telefonica.net

+34 952 64 15 50

Study Officials

• Dr. Francisco Javier Alzueta Rodríguez, PhD

  Hospital Clínico Universitario Virgen de la Victoria

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 15, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 20, 2019
• Results First Posted: March 6, 2015

Record last verified: 2019-02

Locations

ES (1)