Quartet Lead and Resynchronization Therapy Options

Heart Failure Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295840
• Other study ID #: CR 10-046-SP-HF
• Status: Completed
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Cardiac Resynchronization Therapy Defibrillator
Cardiac Resynchronization Therapy Defibrillator

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario Virgen de la Victoria	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At enrollment
Secondary	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.	Enrollment visit (in the seven days after implantation of the device)
Secondary	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.	Enrollment visit (in the seven days after implantation of the device)
Secondary	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.	6 months post-implant
Secondary	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.	Enrollment visit (in the seven days after implantation of the device)
Secondary	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.	At 6 months
Secondary	Number of Patients With PNS in All Vectors	To calculate the number of patients that exhibit PNS in all traditional vector	At enrollment
Secondary	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	At enrollment
Secondary	Number of Patients With PNS in All Vectors	To calculate the number of patients that exhibit PNS in all traditional vector	At 6 months
Secondary	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	At 6 months