Trial Outcomes & Findings for Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination (NCT NCT01410552)

Results Overview

Percentage of patients presenting with inappropriate shock(s)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1013 participants

Primary outcome timeframe

552 days

Results posted on

2019-03-22

Participant milestones
Measure	ICD or CRT-D With PARAD+ only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770: PARADYM ICD and CRT-d with PARAD+ algorithm available
Overall Study STARTED	1013
Overall Study COMPLETED	877
Overall Study NOT COMPLETED	136

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Single Arm n=993 Participants ICD or CRT-D with PARAD+
Age, Continuous	68.0 years n=993 Participants
Sex: Female, Male Female	204 Participants n=993 Participants
Sex: Female, Male Male	789 Participants n=993 Participants

Timeframe: 552 days

Percentage of patients presenting with inappropriate shock(s)

Outcome measures
Measure	Single Arm n=993 Participants ICD or CRT-D with PARAD+
Patients With Inappropriate Shock(s)	1.4 Percentage of pts with inap shocks

Timeframe: 552 days

Percentage of shocks appropriately delivered

Outcome measures
Measure	Single Arm n=993 Participants ICD or CRT-D with PARAD+
Shock(s) Appropriately Delivered	73.7 Percentage of appropriate shocks

Serious events: 282 serious events

Other events: 0 other events

Deaths: 70 deaths

Serious adverse events
Measure	ICD or CRT-D With PARAD+ n=1013 participants at risk only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770: PARADYM ICD and CRT-d with PARAD+ algorithm available
Cardiac disorders Cardiovascular serious adverse event	16.3% 165/1013 • Over a median follow up of 552 days (Q1: 354.0; Q3: 725.0). Serious adverse events and hospitalizations were documented on specific case report forms and classified by the sponsor's safety officer. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Non cardiovascular serious adverse event	13.8% 140/1013 • Over a median follow up of 552 days (Q1: 354.0; Q3: 725.0). Serious adverse events and hospitalizations were documented on specific case report forms and classified by the sponsor's safety officer. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Investigations Device related serious adverse event	3.3% 33/1013 • Over a median follow up of 552 days (Q1: 354.0; Q3: 725.0). Serious adverse events and hospitalizations were documented on specific case report forms and classified by the sponsor's safety officer. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.

Adverse event data not reported

LivaNova

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