DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Quartet Lead and Resynchronization Therapy Options III

Information source: St. Jude Medical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: MPP ON Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead (Device)

Phase: N/A

Status: Not yet recruiting

Sponsored by: St. Jude Medical

Official(s) and/or principal investigator(s):
Elena Llorente, Study Director, Affiliation: St. Jude Medical

Overall contact:
Javier Alzueta, Email: jalzueta@telefonica.net

Summary

The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.

Clinical Details

Official title: Quartet Lead and Resynchronization Therapy Options - Assessing the Response Rate at 6 Months in CRT Patients Implanted With a Quartet Left Ventricular(LV) Quadripolar Lead and the MultiPoint Pacing (MPP) Feature Activated

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The percentage of responder patients.

Secondary outcome:

Reverse LV remodeling

Percentage of super-responders

Detailed description: The primary endpoint of the study is to measure prospectively at 6 months the percentage of responder* patients implanted with a Quartet LV quadripolar lead and with the MultiPoint Pacing feature activated compared with No Pacing at baseline. *A positive CRT response is defined as an improvement of more than 15 % in Left Ventricular End Systolic Volume (LVESV) at 6 months post-implant, measured by Echocardiography.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient that will be implanted with a Cardiac Resynchronization Therapy (CRT-D) with

the MultiPoint Pacing (MPP) feature under the current Guidelines indications for CRT-D implant (including upgrades from single or dual chamber Defibrillator or Pacemaker).

- Patient that will be implanted with a Quartet Left Ventricular (LV) quadripolar lead.

- In sinus rhythm at baseline visit.

- Patients with Left Bundle Branch Block (LBBB)

- Must be willing and able to comply with study requirements.

- Older than 18 years

- Must indicate their understanding of the study and willingness to participate by

signing an appropriate informed consent form. Exclusion Criteria:

- Already has a CRT device implanted.

- Myocardial Infarction or unstable angina within 40 days prior the enrollment.

- New York Heart Association (NYHA) Class IV

- Recent cardiac revascularization in the 4 weeks prior to enrollment.

- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months

prior the enrollment.

- Classification of Status 1 for cardiac transplantation or consideration for

transplantation over the next 12 months.

- Primary valvular disease requiring surgical intervention.

- Atrial Fibrillation (AF):

- Persistent AF at the time of enrollment or 30 days prior the enrollment

- Permanent AF not treated with Atrio-Ventricular node ablation within 2 weeks

after the CRT-D implant

- History or incidence of Paroxysmal or Persistent AF within 30 days prior the

enrollment

- Patient for whom suitable Transthoracic echocardiographic images for determining the

cardiac output (CO) and LV volumes cannot be obtained.

- Undergone a cardiac transplantation or being waiting for it

- Life expectancy < 6 months

- Pregnancy or planning to become pregnant

- Unable to comply with the follow up schedule

- Currently participating in any other clinical investigation.-

Locations and Contacts

Javier Alzueta, Email: jalzueta@telefonica.net

Additional Information

Starting date: July 2015
Last updated: June 18, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017