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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

St. Jude Medical

ClinicalTrials.gov Identifier:

NCT00763698

First received: September 29, 2008

Last updated: September 28, 2011

Last verified: September 2011

History of Changes

Results First Received: July 26, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Heart Failure
Intervention:	Device: QuickFlex Micro Model 1258T Left Heart Lead

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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 These patients were followed for a period of 30 days and then were withdrawn from the study.

Reporting Groups

	Description
QuickFlex Micro 1258T Left Heart Lead	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.

Participant Flow: Overall Study

	QuickFlex Micro 1258T Left Heart Lead
STARTED	86
COMPLETED	76
NOT COMPLETED	10
Unsuccessful Implant	5
Death	4
Withdrawal by Subject	1

Baseline Characteristics

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Reporting Groups

	Description
QuickFlex Micro 1258T Left Heart Lead	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.

Baseline Measures

	QuickFlex Micro 1258T Left Heart Lead
Number of Participants [units: participants]	86
Age [units: participants]
<=18 years	0
Between 18 and 65 years	21
>=65 years	65
Age [units: years] Mean ± Standard Deviation	71.0 ± 11.3
Gender [units: participants]
Female	29
Male	57
Region of Enrollment [units: participants]
United States	86

Outcome Measures

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1. Primary:

Freedom From Left Ventricular Lead-related Complications [ Time Frame: 3 months ]

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Measure Type	Primary
Measure Title	Freedom From Left Ventricular Lead-related Complications
Measure 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
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was conducted on the 81 patients with a successful left ventricular lead implant.

Reporting Groups

	Description
QuickFlex Micro 1258T Left Heart Lead	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.

Measured Values

	QuickFlex Micro 1258T Left Heart Lead
Number of Participants Analyzed [units: participants]	81
Freedom From Left Ventricular Lead-related Complications [units: percent of participants] Number ( 95% Confidence Interval )	100 ( 100 to 100 )

Statistical Analysis 1 for Freedom From Left Ventricular Lead-related Complications

Groups ^[1]	QuickFlex Micro 1258T Left Heart Lead
Objective Performance Criteria ^[2]	80

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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.
[2]	Other relevant estimation information:
	No text entered.

2. Primary:

Percentage of Successful Left Ventricular Lead Implants [ Time Frame: 3 months ]

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3. Primary:

Left Ventricular Bipolar Pacing Capture Threshold (Volts) [ Time Frame: 3 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS 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.

The agreement is:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Director, Clinical Affairs
Organization: St. Jude Medical
phone: (408) 522-6410
e-mail: tshipman@sjm.com

No publications provided

Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00763698 History of Changes
Other Study ID Numbers:	CRD 435
Study First Received:	September 29, 2008
Results First Received:	July 26, 2011
Last Updated:	September 28, 2011
Health Authority:	United States: Food and Drug Administration

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