Trial Outcomes & Findings for Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead (NCT NCT00763698)

NCT ID: NCT00763698

Last Updated: 2019-02-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 86 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2019-02-19

Participant Flow

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.

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 These patients were followed for a period of 30 days and then were withdrawn from the study.

Participant milestones

Measure	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.
Overall Study STARTED	86
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	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.
Overall Study Unsuccessful Implant	5
Overall Study Death	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	QuickFlex Micro 1258T Left Heart Lead n=86 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	65 Participants n=5 Participants
Age, Continuous	71.0 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants
Region of Enrollment United States	86 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

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

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.

Outcome measures

Measure	QuickFlex Micro 1258T Left Heart Lead n=81 Participants 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.
Freedom From Left Ventricular Lead-related Complications	100 percent of participants Interval 100.0 to 100.0

PRIMARY outcome

Timeframe: 3 months

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

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.

Outcome measures

Measure	QuickFlex Micro 1258T Left Heart Lead n=86 Participants 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.
Percentage of Successful Left Ventricular Lead Implants	94 percentage of participants Interval 87.0 to 100.0

PRIMARY outcome

Timeframe: 3 months

Population: 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".

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.

Outcome measures

Measure	QuickFlex Micro 1258T Left Heart Lead n=16 Participants 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.
Left Ventricular Bipolar Pacing Capture Threshold (Volts)	1.1 volts Standard Deviation 0.3

Adverse Events

QuickFlex Micro 1258T Left Heart Lead

Serious events: 4 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	QuickFlex Micro 1258T Left Heart Lead n=86 participants at risk 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.
Cardiac disorders Cardiac vein thrombus	1.2% 1/86 • Number of events 1 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Skin and subcutaneous tissue disorders Hematoma	1.2% 1/86 • Number of events 1 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Surgical and medical procedures Right ventricular lead dislodgement/migration	1.2% 1/86 • Number of events 1 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Cardiac disorders Right ventricular lead cardiac perforation	1.2% 1/86 • Number of events 1 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.

Other adverse events

Measure	QuickFlex Micro 1258T Left Heart Lead n=86 participants at risk 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.
Cardiac disorders Cardiac vein thrombus	1.2% 1/86 • Number of events 1 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Skin and subcutaneous tissue disorders Hematoma	4.7% 4/86 • Number of events 4 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Cardiac disorders High defibrillation threshold	3.5% 3/86 • Number of events 3 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Cardiac disorders Hypotension	1.2% 1/86 • Number of events 1 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Surgical and medical procedures Left ventricular lead dislodgement/migration	1.2% 1/86 • Number of events 1 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Cardiac disorders Elevated left ventricular pacing threshold	1.2% 1/86 • Number of events 1 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Surgical and medical procedures Phrenic Nerve/Diaphragmatic Nerve stimulation	11.6% 10/86 • Number of events 10 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Cardiac disorders Right atrial lead undersensing	1.2% 1/86 • Number of events 1 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Surgical and medical procedures Device pocket stimulation	1.2% 1/86 • Number of events 1 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Cardiac disorders Therapy for non-ventricular rhythm	3.5% 3/86 • Number of events 3 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
Cardiac disorders Atrial Arrhythmia	1.2% 1/86 • Number of events 1 • Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.

Additional Information

Director, Clinical Affairs

St. Jude Medical

Phone: (408) 522-6410

Email: tshipman@sjm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60