Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02548455
• Collaborator: (none)
• Enrollment: 499
• Locations: 30
• Arm: 1
• Actual Duration (Months): 16.8
• Patients Per Site: 16.6
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Quartet 1457Q LV Lead	N/A

Detailed Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 499 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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: Oct 27, 2015
• Actual Primary Completion Date: Aug 19, 2016
• Actual Study Completion Date: Mar 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Subjects implanted with the Quartet 1457Q LV lead	Device: Quartet 1457Q LV Lead

Outcome Measures

Primary Outcome Measures

1. Number of Patients Free From LV Lead-related Complications Through 3 Months [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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.

1. Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead.

2. 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.

3. Are 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

1. Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt

2. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate

3. Patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in other studies may be allowed if pre-approval is granted from the study manager.

4. Are pregnant or planning pregnancy in the next 6 months

5. Have a life expectancy of less than 24 months due to any condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center Research	Huntsville	Alabama	United States	35801
2	Arizona Arrhythmia Research Center	Phoenix	Arizona	United States	85013
3	Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas	United States	72401
4	Scripps Health	La Jolla	California	United States	92037
5	Premier Cardiology, Inc.	Newport Beach	California	United States	92663
6	Stanford University Hospital	Stanford	California	United States	94305
7	Munroe Regional Medical Center	Ocala	Florida	United States	34471
8	Tallahassee Research Institute	Tallahassee	Florida	United States	32308
9	Emory University Hospital	Atlanta	Georgia	United States	30322
10	North Georgia Heart Foundation	Gainesville	Georgia	United States	30501
11	Iowa Heart Center	West Des Moines	Iowa	United States	50266
12	Central Baptist Hospital	Lexington	Kentucky	United States	40503
13	One Health Cardiology	Owensboro	Kentucky	United States	42304
14	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
15	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
16	Thoracic Cardiovascular Healthcare Foundation	Lansing	Michigan	United States	48912
17	Missouri Heart Center	Columbia	Missouri	United States	65201
18	Catholic Medical Center	Manchester	New Hampshire	United States	03102
19	Cardiovascular Associates of Delaware Valley	Haddon Heights	New Jersey	United States	08035
20	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
21	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
22	Oklahoma Heart Institute at Utica	Tulsa	Oklahoma	United States	74104
23	Lancaster General Hospital	Lancaster	Pennsylvania	United States	17602
24	Donald Guthrie Foundation for Education & Research	Sayre	Pennsylvania	United States	18840
25	Greenville Health System	Greenville	South Carolina	United States	29605
26	Erlanger Medical Center	Chattanooga	Tennessee	United States	37403
27	The Stern Cardiovascular Foundation	Germantown	Tennessee	United States	38138
28	The Heart Hospital Baylor Plano	Plano	Texas	United States	75093
29	Swedish Medical Center - Heart & Vascular	Seattle	Washington	United States	98122
30	St. Mary's Hospital	Madison	Wisconsin	United States	53715

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Chair: David Delurgio, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02548455
• Other Study ID Numbers: CRD 616
• First Posted: Sep 14, 2015
• Last Update Posted: Feb 4, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Heart Failure; Ethinyl estradiol, levonorgestrel drug combination

Study Results

Participant Flow

Arm/Group Title	Treatment
Arm/Group Description	Left Ventricular Lead model Quartet 1457Q Left Ventricular Lead
Period Title: Overall Study
STARTED	499
Completed Pre-Discharge	484
Completed 6-Month Follow-up	259
Completed 12-Month Follow-up	61
COMPLETED	259
NOT COMPLETED	240

Baseline Characteristics

Arm/Group Title	Treatment
Arm/Group Description	Left Ventricular Lead model Quartet 1457Q Left Ventricular Lead
Overall Participants	499
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.3 (10.4)
Sex: Female, Male (Count of Participants)
Female	194 38.9%
Male	305 61.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 0.8%
Not Hispanic or Latino	491 98.4%
Unknown or Not Reported	4 0.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	5 1%
Asian	1 0.2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	39 7.8%
White	450 90.2%
More than one race	0 0%
Unknown or Not Reported	4 0.8%
Region of Enrollment (Count of Participants)
United States	499 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Free From LV Lead-related Complications Through 3 Months
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/Group Description	Subjects implanted with the Quartet 1457Q left ventricular lead
Measure Participants	94
Count of Participants [Participants]	4 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment
	Comments	The hypothesis for the endpoint is: H0: Freedom from LV lead-related complications through 3 months (91 days) ≤ 85% H1: Freedom from LV lead-related complications through 3 months (91 days) > 85% A total of 85 subjects were required to have at least 80% power to reject the null hypothesis at the 5% significance level at three months (91 days) post-implant or attempted implant. After accounting for 9% attrition, the required sample size was 94 subjects.
	Type of Statistical Test	Equivalence
	Comments	Freedom from left ventricular lead-related complications through 3 months was estimated to be 96.0% with a 95% lower confidence bound of 92.6% based on the Promote Q IDE study (NCT00990665), and 98.3% with a 95% lower confidence bound of 97.7% based on data from the Quadripolar Post-Approval study (NCT01555619).
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Kaplan-Meier Estimate
	Estimated Value	85
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse event data was collected on all subjects from enrollment through 12 months of follow-up.
Arm/Group Title	Treatment
Arm/Group Description	Subjects implanted with the Quartet 1457Q left ventricular lead
All Cause Mortality
	Treatment
	Affected / at Risk (%)	# Events
Total	27/499 (5.4%)
Serious Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	60/499 (12%)
Infections and infestations
Infections	5/499 (1%)	5
Injury, poisoning and procedural complications
Cardiac Tamponade	3/499 (0.6%)	3
Coronary Sinus Dissection	4/499 (0.8%)	4
Coronary Sinus Perforation	1/499 (0.2%)	1
Excessive Bleeding	2/499 (0.4%)	2
Hematoma/Seroma	1/499 (0.2%)	1
Induced Arrhythmias Atrial/Ventricular	2/499 (0.4%)	2
Infections	1/499 (0.2%)	1
Lead Dislodgement	20/499 (4%)	20
Pectoral/Diaphragmatic Stimulation	1/499 (0.2%)	1
Pericardial Effusion	1/499 (0.2%)	1
Pneumothorax	6/499 (1.2%)	6
Pulmonary Edema	2/499 (0.4%)	2
Rise in Threshold	1/499 (0.2%)	1
Anesthesia Complication	1/499 (0.2%)	1
Cardiogenic Shock	1/499 (0.2%)	1
Elevated Pacing Threshold	1/499 (0.2%)	1
Guide Wire Problem	1/499 (0.2%)	1
Hypotension	1/499 (0.2%)	1
Loose Set Screw	1/499 (0.2%)	1
Upper Extremity Deep Vein Thrombosis	2/499 (0.4%)	2
Product Issues
Lead Dislodgement	14/499 (2.8%)	14
Loss of Pacing/Sensing	1/499 (0.2%)	1
Rise in Threshold	1/499 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory Compromise	1/499 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	56/499 (11.2%)
General disorders
Oversensing	2/499 (0.4%)	2
Injury, poisoning and procedural complications
Cardiac/Coronary Sinus Dissection	2/499 (0.4%)	2
Cardiac/Coronary Sinus Perforation	1/499 (0.2%)	1
Hematoma/Seroma	7/499 (1.4%)	7
Induced Atrial or Ventricular Arrythmias	1/499 (0.2%)	1
Infection	1/499 (0.2%)	1
Lead Dislodgement	5/499 (1%)	6
Pectoral/Diaphramatic/Phrenic Nerve Stimulation	20/499 (4%)	22
Upper Extremity Discomfort	1/499 (0.2%)	1
Oversensing	1/499 (0.2%)	1
Should Pain	1/499 (0.2%)	1
Suture Sleeve Disruption	1/499 (0.2%)	1
Upper Extremity Deep Vein Thrombosis	3/499 (0.6%)	3
Product Issues
Lead Dislodgement	1/499 (0.2%)	1
Pectoral/Diaphramatic/Phrenic Nerve Stimulation	10/499 (2%)	10
Device Reset Mode	1/499 (0.2%)	1
Elevated Threshold	1/499 (0.2%)	1
Oversensing	1/499 (0.2%)	1
Skin and subcutaneous tissue disorders
Local Tissue Reaction; Formation of Fibrotic Tissue	1/499 (0.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.