Trial Outcomes & Findings for Actions Elicited by In-hospital Follow-up of Cardiac Devices (NCT NCT01073449)

Results Overview

Recruitment status

COMPLETED

Target enrollment

3362 participants

Primary outcome timeframe

4 months

Results posted on

2011-02-28

Participant milestones
Measure	Cardiac Device All patients implanted with a cardiac device (PM or ICD)
Overall Study STARTED	3362
Overall Study COMPLETED	3362
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Actions Elicited by In-hospital Follow-up of Cardiac Devices

Baseline characteristics by cohort
Measure	Cardiac Device n=3362 Participants All patients implanted with a cardiac device (PM or ICD)
Age, Categorical <=18 years	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	640 Participants n=5 Participants
Age, Categorical >=65 years	2718 Participants n=5 Participants
Age Continuous	73.36 years STANDARD_DEVIATION 12.16 • n=5 Participants
Sex: Female, Male Female	1156 Participants n=5 Participants
Sex: Female, Male Male	2206 Participants n=5 Participants
Region of Enrollment Italy	3362 participants n=5 Participants

Timeframe: 4 months

Outcome measures
Measure	Cardiac Device n=3362 Participants All patients implanted with a cardiac device (PM or ICD)
Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up	767 Participants Interval 719.0 to 816.0

Timeframe: 4 months

Population: 2246 represents the number of patients in the whole population that were implanted with a PM

Outcome measures
Measure	Cardiac Device n=2246 Participants All patients implanted with a cardiac device (PM or ICD)
Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up	512 Participants Interval 492.0 to 532.0

Timeframe: 4 months

Population: 693 represents the number of patients implanted with an ICD within the whole population

Outcome measures
Measure	Cardiac Device n=693 Participants All patients implanted with a cardiac device (PM or ICD)
Number of Patients - Amongst Those Implanted With an Implantable Cardioverter Defibrillator (ICD)- in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up	129 Participants Interval 128.0 to 130.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Dept. of Arrhythmology - Cliniche Humanitas Gavazzeni

Phone: +39 035 4204159