Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Subjects implanted with the Quartet 1457Q LV lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quartet 1457Q LV Lead | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Free From LV Lead-related Complications Through 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. | 3 months |
Not provided
Not provided
Inclusion Criteria:
Meets current St. Jude Medical clinical indication for implantation of a cardiac resynchronization therapy system:
" to provide a reduction of the symptoms of moderate to severe heart failure (New York Heart Association Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, OR " to maintain synchrony of the left and right ventricles in patients who have undergone an Atrio Ventricular nodal ablation for chronic (permanent) atrial fibrillation and have New York Heart Association Functional Class II or III heart failure.
Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead.
Have the ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Are 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Delurgio, MD | Emory University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research | Huntsville | Alabama | 35801 | United States | ||
| Arizona Arrhythmia Research Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Left Ventricular Lead model Quartet 1457Q Left Ventricular Lead |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Cardiology Associates of Northeast Arkansas | Jonesboro | Arkansas | 72401 | United States |
| Scripps Health | La Jolla | California | 92037 | United States |
| Premier Cardiology, Inc. | Newport Beach | California | 92663 | United States |
| Stanford University Hospital | Stanford | California | 94305 | United States |
| Munroe Regional Medical Center | Ocala | Florida | 34471 | United States |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| North Georgia Heart Foundation | Gainesville | Georgia | 30501 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| One Health Cardiology | Owensboro | Kentucky | 42304 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Thoracic Cardiovascular Healthcare Foundation | Lansing | Michigan | 48912 | United States |
| Missouri Heart Center | Columbia | Missouri | 65201 | United States |
| Catholic Medical Center | Manchester | New Hampshire | 03102 | United States |
| Cardiovascular Associates of Delaware Valley | Haddon Heights | New Jersey | 08035 | United States |
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Oklahoma Heart Institute at Utica | Tulsa | Oklahoma | 74104 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17602 | United States |
| Donald Guthrie Foundation for Education & Research | Sayre | Pennsylvania | 18840 | United States |
| Greenville Health System | Greenville | South Carolina | 29605 | United States |
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | United States |
| The Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Swedish Medical Center - Heart & Vascular | Seattle | Washington | 98122 | United States |
| St. Mary's Hospital | Madison | Wisconsin | 53715 | United States |
|
| Completed Pre-Discharge |
|
| Completed 6-Month Follow-up |
|
| Completed 12-Month Follow-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Left Ventricular Lead model Quartet 1457Q Left Ventricular Lead |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Free From LV Lead-related Complications Through 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. | The first 94 subjects who underwent an attempted implant of the Quartet 1457Q lead and either completed a 3-month follow-up visit, withdrew from the study or died prior to the 3-month follow-up visit. | Posted | Count of Participants | Participants | 3 months |
|
|
|
|
Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Subjects implanted with the Quartet 1457Q left ventricular lead | 27 | 499 | 60 | 499 | 56 | 499 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Tamponade | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Coronary Sinus Dissection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Coronary Sinus Perforation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Excessive Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hematoma/Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Induced Arrhythmias Atrial/Ventricular | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infections | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infections | Infections and infestations | Systematic Assessment |
| ||
| Lead Dislodgement | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Lead Dislodgement | Product Issues | Systematic Assessment |
| ||
| Loss of Pacing/Sensing | Product Issues | Systematic Assessment |
| ||
| Pectoral/Diaphragmatic Stimulation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pericardial Effusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pneumothorax | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pulmonary Edema | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Rise in Threshold | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Rise in Threshold | Product Issues | Systematic Assessment |
| ||
| Anesthesia Complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cardiogenic Shock | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Elevated Pacing Threshold | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Guide Wire Problem | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Loose Set Screw | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Respiratory Compromise | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Upper Extremity Deep Vein Thrombosis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac/Coronary Sinus Dissection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cardiac/Coronary Sinus Perforation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hematoma/Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Induced Atrial or Ventricular Arrythmias | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Lead Dislodgement | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Lead Dislodgement | Product Issues | Systematic Assessment |
| ||
| Local Tissue Reaction; Formation of Fibrotic Tissue | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pectoral/Diaphramatic/Phrenic Nerve Stimulation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pectoral/Diaphramatic/Phrenic Nerve Stimulation | Product Issues | Systematic Assessment |
| ||
| Oversensing | General disorders | Systematic Assessment |
| ||
| Upper Extremity Discomfort | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Oversensing | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Should Pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Suture Sleeve Disruption | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Upper Extremity Deep Vein Thrombosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Device Reset Mode | Product Issues | Systematic Assessment |
| ||
| Elevated Threshold | Product Issues | Systematic Assessment |
| ||
| Oversensing | Product Issues | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clay Cohorn, Clinical Program Director | Abbott | 972-309-8087 | clay.cohorn@abbott.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|