Trial Outcomes & Findings for Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications (NCT NCT00976482)

Last Updated: 2017-02-01

Results Overview

Recruitment status

COMPLETED

Target enrollment

1745 participants

Primary outcome timeframe

2 years

Results posted on

2017-02-01

Participant milestones
Measure	Pacemaker Patients currently implanted with permanent Pacemaker according to guidelines
Overall Study STARTED	1745
Overall Study Eligible for Last Follow up	1487
Overall Study COMPLETED	1486
Overall Study NOT COMPLETED	259

Reasons for withdrawal
Measure	Pacemaker Patients currently implanted with permanent Pacemaker according to guidelines
Overall Study Death	208
Overall Study Withdrawal by Subject	45
Overall Study Center terminated	1
Overall Study Protocol Violation	5

Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

Baseline characteristics by cohort
Measure	Pacemaker n=1740 Participants Patients currently implanted with permanent Pacemaker according to guidelines
Age, Continuous	76 years STANDARD_DEVIATION 10 • n=99 Participants
Gender Female	1047 Participants n=99 Participants
Gender Male	693 Participants n=99 Participants
Primary Indication for Permanent Pacing sinus node dysfunction	565 participants n=99 Participants
Primary Indication for Permanent Pacing Atrioventricular Block	840 participants n=99 Participants
Primary Indication for Permanent Pacing Neuro-mediated	61 participants n=99 Participants
Primary Indication for Permanent Pacing Permanent AF with Slow Ventr. Response	274 participants n=99 Participants

Timeframe: 2 years

Outcome measures
Measure	Pacemaker n=1740 Participants Patients currently implanted with permanent Pacemaker according to guidelines
Two-year All-cause Mortality	11 percentage of participants Interval 9.3 to 13.8

Serious events: 611 serious events

Other events: 206 other events

Deaths: 0 deaths

Serious adverse events
Measure	Pacemaker n=1740 participants at risk implanted Patients
Cardiac disorders disease progression leading to death	12.0% 208/1740 • Number of events 208
Cardiac disorders leading to invasive interventions	23.2% 403/1740 • Number of events 632

Other adverse events
Measure	Pacemaker n=1740 participants at risk implanted Patients
Cardiac disorders atrial fibrillation	11.8% 206/1740

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