Trial Outcomes & Findings for COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring (NCT NCT00396136)

NCT ID: NCT00396136

Last Updated: 2012-05-28

Results Overview

Evaluate threshold voltage of the COROX OTW Unipolar Lead.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 221 participants
• Primary outcome timeframe: All follow-ups for 3 years post implant
• Results posted on: 2012-05-28

Participant Flow

Participant milestones

Measure	Corox OTW Unipolar Lead Study Participants followed for three years post implant.
Overall Study STARTED	221
Overall Study COMPLETED	96
Overall Study NOT COMPLETED	125

Reasons for withdrawal

Measure	Corox OTW Unipolar Lead Study Participants followed for three years post implant.
Overall Study Death	43
Overall Study Withdrawal by Subject	59
Overall Study Lost to Follow-up	15
Overall Study Study device explanted	8

Baseline Characteristics

COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring

Baseline characteristics by cohort

Measure	Corox OTW Unipolar Lead n=221 Participants Study Participants followed for three years post implant.
Age Continuous	67.3 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	168 Participants n=5 Participants
Region of Enrollment United States	221 participants n=5 Participants

PRIMARY outcome

Timeframe: All follow-ups for 3 years post implant

Population: All study participants.

Evaluate threshold voltage of the COROX OTW Unipolar Lead.

Outcome measures

Measure	Corox OTW Unipolar Lead n=1130 LV Lead Threshold Tests Study Participants followed for three years post implant.
Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing	1.3 Threshold Voltage Standard Deviation 1.1

PRIMARY outcome

Timeframe: 3 years post implant

Population: All study participants.

Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve.

Outcome measures

Measure	Corox OTW Unipolar Lead n=221 Participants Study Participants followed for three years post implant.
Safety of the COROX OTW Steroid LV Pacing Lead	9 participants

Adverse Events

Group 1

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=221 participants at risk
Cardiac disorders High LV Lead Threshold	0.90% 2/221 • Number of events 2
Surgical and medical procedures Infection	0.90% 2/221 • Number of events 2
Cardiac disorders LV Lead Dislodgement	1.4% 3/221 • Number of events 3
Surgical and medical procedures Lead Integrity Comprimised noted at Device Change-Out	0.45% 1/221 • Number of events 1
Cardiac disorders Phrenic Nerve Stimulation	0.45% 1/221 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Clinical Studies

Biotronik, Inc.

Phone: 503-451-8050

Email: katerina.demetz@biotronik.com

Results disclosure agreements

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

Restriction type: OTHER