Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00763698
• Collaborator: (none)
• Enrollment: 86
• Locations: 13
• Arm: 1
• Duration (Months): 19
• Patients Per Site: 6.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. The study will be conducted at a maximum of 20 investigational centers located in the United States and a total of 68 patients will be enrolled.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: QuickFlex Micro Model 1258T Left Heart Lead	N/A

Detailed Description

The investigational left heart lead, QuickFlex Model 1258T, will be implanted with a legally marketed St. Jude Medical cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) device.

Patients will be followed at Pre-Discharge, 1-Month, 3-Month,and then every 6 months until the end of the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: QuickFlex Micro Model 1258T Left Heart Pacing Lead
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QuickFlex micro 1258T left heart lead	Device: QuickFlex Micro Model 1258T Left Heart Lead; Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.; Other Names: Model 1258T left heart pacing lead

Outcome Measures

Primary Outcome Measures

1. Freedom From Left Ventricular Lead-related Complications [3 months]

   A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.

2. Percentage of Successful Left Ventricular Lead Implants [3 months]

   Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.

3. Left Ventricular Bipolar Pacing Capture Threshold (Volts) [3 months]

   The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of < 3 volts is required to meet this endpoint.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Approved indication for CRT-D system

Exclusion Criteria:

• Previous cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment

• Previous left ventricular (LV) lead implant

• Have had a heart attack,unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA),coronary artery bypass grafting (CABG), Stent) within 40 days prior to enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital-University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Arkansas Cardiology	Little Rock	Arkansas	United States	72205
3	Arkansas Heart Hospital	Little Rock	Arkansas	United States	72211
4	Glendale Memorial Hospital and Medical Center	Glendale	California	United States	91204
5	Regional Cardiology Associates	Sacramento	California	United States	95819
6	Midwest Heart Foundation	Lombard	Illinois	United States	60148
7	Central Baptist Hospital	Lexington	Kentucky	United States	40503
8	St. John Hospital and Medical Center	Detroit	Michigan	United States	48236
9	Thoracic Cardiovascular Healthcare Foundation	Lansing	Michigan	United States	48910
10	Deborah Heart and Lung Center	Browns Mills	New Jersey	United States	08015
11	St. Francis Hospital	Roslyn	New York	United States	11576
12	EMH Regional Medical Center	Elyria	Ohio	United States	44035
13	St. Thomas Hospital	Nashville	Tennessee	United States	37205

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Director: Tamara Shipman, Abbott Medical Devices

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00763698
• Other Study ID Numbers: CRD 435
• First Posted: Oct 1, 2008
• Last Update Posted: Feb 19, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Abbott Medical Devices: Left heart pacing lead; Cardiac resynchronization therapy (CRT); Heart failure; ICD
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Recruitment Details	The study was conducted at 18 investigational centers located in the United States (US). The first patient was enrolled on October 30, 2008 and follow up was completed on May 31, 2009.
Pre-assignment Detail	All patients were included in the study analysis with the exception of patients who underwent unsuccessful implantation of the 1258T lead system. These patients were followed for a period of 30 days and then were withdrawn from the study.

Arm/Group Title	QuickFlex Micro 1258T Left Heart Lead
Arm/Group Description	All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
Period Title: Overall Study
STARTED	86
COMPLETED	76
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	QuickFlex Micro 1258T Left Heart Lead
Arm/Group Description	All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
Overall Participants	86
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	21 24.4%
>=65 years	65 75.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.0 (11.3)
Sex: Female, Male (Count of Participants)
Female	29 33.7%
Male	57 66.3%
Region of Enrollment (participants) [Number]
United States	86 100%

Outcome Measures

1. Primary Outcome

Title	Freedom From Left Ventricular Lead-related Complications
Description	A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Analysis was conducted on the 81 patients with a successful left ventricular lead implant.

Arm/Group Title	QuickFlex Micro 1258T Left Heart Lead
Arm/Group Description	All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
Measure Participants	81
Number (95% Confidence Interval) [percent of participants]	100 116.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	QuickFlex Micro 1258T Left Heart Lead
	Comments	The objective performance criteria established for freedom from left ventricular lead related complications at 3 months was greater than 80%. At least 80% of the patients were required to be free from left venticular lead related complications at 3 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Objective Performance Criteria
	Estimated Value	80
	Confidence Interval	(1-Sided) 95%; 5 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Successful Left Ventricular Lead Implants
Description	Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

All patients with an implant or attempted implant were included in the analysis.

Arm/Group Title	QuickFlex Micro 1258T Left Heart Lead
Arm/Group Description	All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
Measure Participants	86
Number (95% Confidence Interval) [percentage of participants]	94 109.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	QuickFlex Micro 1258T Left Heart Lead
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Objective Performance Criteria
	Estimated Value	80
	Confidence Interval	(1-Sided) 97.5%; 2.5 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Left Ventricular Bipolar Pacing Capture Threshold (Volts)
Description	The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of < 3 volts is required to meet this endpoint.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

This effectiveness endpoint was carried out on the first 16 patients who had a LV lead bipolar pacing capture threshold measurement at 3 months at 0.5 ms pulse width. This patient cohort is referred to as the "Primary Pacing Capture Threshold Patient Cohort".

Arm/Group Title	QuickFlex Micro 1258T Left Heart Leads
Arm/Group Description	Patients included in this analysis include the first 16 patients to provide LV lead bipolar pacing capture threshold data at 3 months with a pulse width of 0.5 ms.
Measure Participants	16
Mean (Standard Deviation) [volts]	1.1 (0.3)

Adverse Events

Time Frame	Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Arm/Group Title	QuickFlex Micro 1258T Left Heart Lead
Arm/Group Description	All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
All Cause Mortality
	QuickFlex Micro 1258T Left Heart Lead
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	QuickFlex Micro 1258T Left Heart Lead
	Affected / at Risk (%)	# Events
Total	4/86 (4.7%)
Cardiac disorders
Cardiac vein thrombus	1/86 (1.2%)	1
Right ventricular lead cardiac perforation	1/86 (1.2%)	1
Skin and subcutaneous tissue disorders
Hematoma	1/86 (1.2%)	1
Surgical and medical procedures
Right ventricular lead dislodgement/migration	1/86 (1.2%)	1
Other (Not Including Serious) Adverse Events
	QuickFlex Micro 1258T Left Heart Lead
	Affected / at Risk (%)	# Events
Total	20/86 (23.3%)
Cardiac disorders
Cardiac vein thrombus	1/86 (1.2%)	1
High defibrillation threshold	3/86 (3.5%)	3
Hypotension	1/86 (1.2%)	1
Elevated left ventricular pacing threshold	1/86 (1.2%)	1
Right atrial lead undersensing	1/86 (1.2%)	1
Therapy for non-ventricular rhythm	3/86 (3.5%)	3
Atrial Arrhythmia	1/86 (1.2%)	1
Skin and subcutaneous tissue disorders
Hematoma	4/86 (4.7%)	4
Surgical and medical procedures
Left ventricular lead dislodgement/migration	1/86 (1.2%)	1
Phrenic Nerve/Diaphragmatic Nerve stimulation	10/86 (11.6%)	10
Device pocket stimulation	1/86 (1.2%)	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.