Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02548455|
Recruitment Status : Completed
First Posted : September 14, 2015
Results First Posted : May 8, 2018
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: Quartet 1457Q LV Lead||Not Applicable|
This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead.
A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide.
All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||499 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study|
|Actual Study Start Date :||October 27, 2015|
|Actual Primary Completion Date :||August 19, 2016|
|Actual Study Completion Date :||March 21, 2017|
Subjects implanted with the Quartet 1457Q LV lead
Device: Quartet 1457Q LV Lead
- Number of Patients Free From LV Lead-related Complications Through 3 Months [ Time Frame: 3 months ]A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead. A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548455
|Study Chair:||David Delurgio, MD||Emory University|