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Quartet Lead and Resynchronization Therapy Options (QUARTO)

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy Defibrillator
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Patients who have provided written informed consent
  3. Patients who are in sinus rhythm.
  4. Patients older than 18 years of age.

Exclusion Criteria:

  1. Patients in atrial fibrillation at the time of the echocardiographic study of the enrollment visit.
  2. Patients with valvular disease.
  3. Patients in functional class New York Heart Association (NYHA) IV
  4. Patients for whom echocardiography images suitable for determining the cardiac output cannot be obtained.
  5. Patients whose device has been changed/upgraded.
  6. Pregnant patients.
  7. Patients who do not fulfill all the inclusion criteria.
  8. Patients who are unable to provide written informed consent

Sites / Locations

  • Hospital Clínico Universitario Virgen de la Victoria

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

CRT therapy

Arm Description

Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors
In patients with best CO obtained from Non-traditional, to calculate the percent difference between the best CO from Non-traditional vectors and best CO from Traditional vectors, vectors.This percentage was the CO from Non-traditional vectors minus CO from Traditional vectors then divided by CO from Traditional vectors. The Quartet® lead has 4 poles: Distal (D1), Mid 2 (M2), Mid 3 (M3) and Proximal (P4). The 3 Traditional vectors are the traditional configurations available in a standard bipolar lead: D1-M2, D1-Right Ventricular Coil (RVC) and M2-RVC. The 7 Non-traditional vectors are the additional configurations available in a Quartet® lead: D1-P4, M2-P4, M3-M2, M3-RVC, M3-P4, P4-M2 and P4-RVC.
Cardiac Output (CO) With Different Configurations at Enrollment
Means of baseline non-paced CO, best CO obtained from traditional configurations and best CO obtained from all quadripolar configurations at enrollment.
Capture Threshold
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Capture Threshold
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Number of Vectors With Phrenic Nerve Stimulation (PNS)
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, while maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Number of Vectors With Phrenic Nerve Stimulation (PNS)
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Number of Patients With PNS in All Vectors
To calculate the number of patients that exhibit PNS in all traditional vector
Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector
To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector
Number of Patients With PNS in All Vectors
To calculate the number of patients that exhibit PNS in all traditional vector
Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector
To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector

Full Information

First Posted
February 3, 2011
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01295840
Brief Title
Quartet Lead and Resynchronization Therapy Options
Acronym
QUARTO
Official Title
QUARTET LEAD AND RESYNCHRONIZATION THERAPY OPTIONS To Investigate the Stimulatory Possibilities Offered by the Different Configurations Available for the Quartet Lead and Their Effect on Haemodynamic and Clinical Response.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a prospective, non-randomised, multi-centre, national, interventional clinical trial of a medical device. This trial involves two visits: one at the beginning of the study, which will be undertaken in the seven days following implant, and another visit at 6 months after enrollment. It is recommended that the enrollment visit is undertaken as soon as possible after implantation, although the time window allows the timing to be adapted to each centre's standard practice. Resynchronization therapy in those patients suitable for participation in this trial is expected to begin once this enrollment visit has been completed. Once data collection at enrollment visit has been completed, final device programming will be based on each investigator's criteria and will be undertaken following the standard practice of each centre.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT therapy
Arm Type
No Intervention
Arm Description
Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy Defibrillator
Other Intervention Name(s)
Promote Q. Model, Promote Quadra™., Quartet®: Tetrapolar left ventricular lead. Model 1458Q.
Intervention Description
Cardiac Resynchronization Therapy Defibrillator
Primary Outcome Measure Information:
Title
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.
Time Frame
Enrollment visit (in the seven days after implantation of the device)
Secondary Outcome Measure Information:
Title
Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors
Description
In patients with best CO obtained from Non-traditional, to calculate the percent difference between the best CO from Non-traditional vectors and best CO from Traditional vectors, vectors.This percentage was the CO from Non-traditional vectors minus CO from Traditional vectors then divided by CO from Traditional vectors. The Quartet® lead has 4 poles: Distal (D1), Mid 2 (M2), Mid 3 (M3) and Proximal (P4). The 3 Traditional vectors are the traditional configurations available in a standard bipolar lead: D1-M2, D1-Right Ventricular Coil (RVC) and M2-RVC. The 7 Non-traditional vectors are the additional configurations available in a Quartet® lead: D1-P4, M2-P4, M3-M2, M3-RVC, M3-P4, P4-M2 and P4-RVC.
Time Frame
At enrollment
Title
Cardiac Output (CO) With Different Configurations at Enrollment
Description
Means of baseline non-paced CO, best CO obtained from traditional configurations and best CO obtained from all quadripolar configurations at enrollment.
Time Frame
Enrollment visit (in the seven days after implantation of the device)
Title
Capture Threshold
Description
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Time Frame
Enrollment visit (in the seven days after implantation of the device)
Title
Capture Threshold
Description
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Time Frame
6 months post-implant
Title
Number of Vectors With Phrenic Nerve Stimulation (PNS)
Description
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, while maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Time Frame
Enrollment visit (in the seven days after implantation of the device)
Title
Number of Vectors With Phrenic Nerve Stimulation (PNS)
Description
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Time Frame
At 6 months
Title
Number of Patients With PNS in All Vectors
Description
To calculate the number of patients that exhibit PNS in all traditional vector
Time Frame
At enrollment
Title
Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector
Description
To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector
Time Frame
At enrollment
Title
Number of Patients With PNS in All Vectors
Description
To calculate the number of patients that exhibit PNS in all traditional vector
Time Frame
At 6 months
Title
Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector
Description
To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 do not fulfill all the inclusion criteria. Patients who are unable to provide written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Francisco Javier Alzueta Rodríguez, PhD
Organizational Affiliation
Hospital Clínico Universitario Virgen de la Victoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain

12. IPD Sharing Statement

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Quartet Lead and Resynchronization Therapy Options

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