Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00990665
• Collaborator: (none)
• Enrollment: 178
• Locations: 24
• Arm: 1
• Duration (Months): 34
• Patients Per Site: 7.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 178 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CRT-D and LV lead	Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system); Promote Q CRT-D and Quartet LV lead

Outcome Measures

Primary Outcome Measures

1. Freedom From Left Ventricular Lead-Related Complications Through 3 Months [3 months]

   The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.

2. Freedom From System-related Complications Through 3 Months [3 Months]

   The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.

3. The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months. [3 Months]

   The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)

• Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.

• 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

Exclusion Criteria:

• Have had a recent CVA or TIA within three months of enrollment

• Have a contraindication for an emergency thoracotomy

• Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin

• Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months

• Have undergone a cardiac transplantation within 40 days of enrollment

• Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment

• Are currently participating in a clinical investigation that includes an active treatment arm

• Are pregnant or planning to become pregnant during the duration of the study

• Have a life expectancy of less than 6 months due to any condition

• Are less than 18 years of age

• Are unable to comply with the follow up schedule

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Baptist Health Medical Center	Little Rock	Arkansas	United States	72205
3	Arkansas Heart Hospital	Little Rock	Arkansas	United States	72211
4	Glendale Memorial Medical Center	Glendale	California	United States	91204
5	University of Southern California	Los Angeles	California	United States	90033
6	ACS Research Group	Mountain View	California	United States	94040
7	Regional Cardiology Associates	Sacramento	California	United States	95819
8	Scripps Green Hospital	San Diego	California	United States	92037
9	Orlando Heart Center	Orlando	Florida	United States	32806
10	The Heart and Vascular Institute of Florida - S. Pinellas	Saint Petersburg	Florida	United States	33705
11	Piedmont Hospital	Atlanta	Georgia	United States	30309
12	Midwest Heart Foundation	Lombard	Illinois	United States	60148
13	Central Baptist Hospital	Lexington	Kentucky	United States	40503
14	Lahey Clinical Medical Center	Burlington	Massachusetts	United States	01805
15	Thoracic Cardiovascular Healthcare Foundation	Lansing	Michigan	United States	48910
16	Deborah Heart and Lung Center	Browns Mills	New Jersey	United States	08015
17	Morristown Memorial Hospital	Morristown	New Jersey	United States	07962
18	Mount Sinai Hospital	New York	New York	United States	10029
19	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
20	EMH Regional Medical Center	Elyria	Ohio	United States	44035
21	Lancaster Heart Foundation	Lancaster	Pennsylvania	United States	17602
22	Methodist University Hospital	Memphis	Tennessee	United States	38104
23	St. Thomas Hospital	Nashville	Tennessee	United States	37205
24	Arrhythmia Center for Southern Wisconsin	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Chair: Gery Tomassoni, MD, Central Baptist Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00990665
• Other Study ID Numbers: 60024498/E
• First Posted: Oct 7, 2009
• Last Update Posted: Feb 27, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Abbott Medical Devices: CRT; Heart Failure; LV Leads
• Additional relevant MeSH terms: Heart Failure; Ethinyl estradiol, levonorgestrel drug combination

Study Results

Participant Flow

Arm/Group Title	CRT-D and LV Lead
Arm/Group Description	CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead
Period Title: Overall Study
STARTED	178
COMPLETED	130
NOT COMPLETED	48

Baseline Characteristics

Arm/Group Title	CRT-D and LV Lead
Arm/Group Description	CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead
Overall Participants	178
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68 (11)
Sex: Female, Male (Count of Participants)
Female	56 31.5%
Male	122 68.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	5 2.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	29 16.3%
White	140 78.7%
More than one race	2 1.1%
Unknown or Not Reported	2 1.1%
New York Heart Association Class (participants) [Number]
Class III	175 98.3%
Class IV	3 1.7%

Outcome Measures

1. Primary Outcome

Title	Freedom From Left Ventricular Lead-Related Complications Through 3 Months
Description	The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Patients implanted with a Promote Q CRT-D device and Quartet LV lead.

Arm/Group Title	CRT-D and LV Lead
Arm/Group Description	CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead
Measure Participants	178
Number (97.5% Confidence Interval) [percentage probability]	96

2. Primary Outcome

Title	Freedom From System-related Complications Through 3 Months
Description	The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

Participants implanted with a Promote Q CRT-D device and Quartet LV lead.

Arm/Group Title	CRT-D and LV Lead
Arm/Group Description	CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead
Measure Participants	178
Number (97.5% Confidence Interval) [percentage probability]	92

3. Primary Outcome

Title	The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months.
Description	The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil).
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Per Statistical Analysis Plan	Patients Per Complete Case Analysis
Arm/Group Description	Total number of participants enrolled in the study (with an attempted implant of a Promote Q CRT-D and Quartet LV lead including unsuccessful implants).	Complete case analysis includes only the number of patients that were successfully implanted with the Promote Q CRT-D and Quartet LV lead.
Measure Participants	178	162
Number (97.5% Confidence Interval) [percentage of participants]	79.2 44.5%	83.3 NaN

Adverse Events

Arm/Group Title	CRT-D and LV Lead
Arm/Group Description	CRT-D and LV Lead
All Cause Mortality
	CRT-D and LV Lead
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	CRT-D and LV Lead
	Affected / at Risk (%)	# Events
Total	0/178 (0%)
Other (Not Including Serious) Adverse Events
	CRT-D and LV Lead
	Affected / at Risk (%)	# Events
Total	76/178 (42.7%)
Cardiac disorders
Complications	28/178 (15.7%)	36
Observations	48/178 (27%)	59

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.