Trial Outcomes & Findings for Model 20105 Lead Study (NCT NCT02301429)

Results Overview

All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

1 month

Results posted on

2016-10-26

Participant milestones
Measure	Model 20105 Receiving the model 20105 Lead Model 20105: implant and follow-up of study device
Overall Study STARTED	16
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Model 20105 Receiving the model 20105 Lead Model 20105: implant and follow-up of study device
Overall Study not acceptable vascular anatomy	3

Model 20105 Lead Study

Baseline characteristics by cohort
Measure	Model 20105 n=16 Participants Receiving the model 20105 Lead Model 20105: implant and follow-up of study device
Age, Continuous	73.2 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
QRS duration	108.7 msec STANDARD_DEVIATION 17.6 • n=5 Participants

Timeframe: 1 month

Population: all subject who underwent a Model 20105 Lead implant attempt are considered in this analysis

All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.

Outcome measures
Measure	Model 20105 n=13 Participants Receiving the model 20105 Lead Model 20105: implant and follow-up of study device
All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.	3 Adverse Events

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events
Measure	Model 20105 n=13 participants at risk Receiving the model 20105 Lead Model 20105: implant and follow-up of study device
Injury, poisoning and procedural complications Coronary Sinus Dissection	7.7% 1/13 • Number of events 1
Injury, poisoning and procedural complications Iatrogenic pneumothorax	7.7% 1/13 • Number of events 1
Surgical and medical procedures Coronary Artery Stent Insertion	7.7% 1/13 • Number of events 1

Other adverse events
Measure	Model 20105 n=13 participants at risk Receiving the model 20105 Lead Model 20105: implant and follow-up of study device
Injury, poisoning and procedural complications Coronary Sinus Dissection	7.7% 1/13 • Number of events 1
Cardiac disorders Atrioventricular nodal reentrant tachycardia	7.7% 1/13 • Number of events 1
Cardiac disorders Angina Pectoris	7.7% 1/13 • Number of events 1

Medtronic Regional Clinical Center

Phone: 0039(0)22 241371

Restriction type: GT60