Trial Outcomes & Findings for Model 4965 Post-Approval Study (NCT NCT01076348)

Last Updated: 2019-02-27

Results Overview

A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.

Recruitment status

COMPLETED

Target enrollment

73 participants

Primary outcome timeframe

1 year

Results posted on

2019-02-27

Participant Flow

The study utilized centers that had implanted model 4965 leads in adult subjects to obtain information regarding safety, lead events, and lead survival.

Participant milestones

Participant milestones
Measure	Medtronic 4965 Subjects Single arm registry of Model 4965 implanted patients
Overall Study STARTED	73
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Model 4965 Post-Approval Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medtronic 4965 Subjects n=73 Participants Single arm registry of Model 4965 implanted patients
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=93 Participants
Age, Categorical >=65 years	41 Participants n=93 Participants
Age, Continuous	61.8 years STANDARD_DEVIATION 15.5 • n=93 Participants
Sex: Female, Male Female	29 Participants n=93 Participants
Sex: Female, Male Male	44 Participants n=93 Participants
Region of Enrollment United States	72 participants n=93 Participants
Region of Enrollment Germany	1 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Patients ≥ 19 yrs at implant of MDT 4965 Epicardial Lead.

A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.

Outcome measures

Outcome measures
Measure	Medtronic 4965 Epicardial Lead n=98 4965 leads Subjects who were implanted with at least 1 model 4965 lead.
Model 4965 Complication Free Rate	98.8 Model 4965 complication free rate Interval 91.8 to 99.8

Adverse Events

Medtronic 4965 Subjects

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Medtronic 4965 Subjects n=73 participants at risk Single arm registry of Model 4965 implanted patients
Vascular disorders Failure to capture	1.4% 1/73 • Number of events 1 For this study, "serious" is defined as requiring an invasive intervention to resolve.
Vascular disorders Lead conductor fracture	1.4% 1/73 • Number of events 1 For this study, "serious" is defined as requiring an invasive intervention to resolve.

Other adverse events

Adverse event data not reported

Additional Information

Stefanie Lorinser, Sr. Clinical Research Specialist

Medtronic, Inc.

Phone: 763-526-2742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place