Trial Outcomes & Findings for Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III (NCT NCT00617175)

Last Updated: 2025-07-02

Results Overview

for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed. The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times \* 100.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1902 participants

Primary outcome timeframe

From enrollment to study completion or exit whichever occured first

Results posted on

2025-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Short NID Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia	Long NID Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
Overall Study STARTED	954	948
Overall Study COMPLETED	954	948
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Short NID n=954 Participants Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia	Long NID n=948 Participants Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia	Total n=1902 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	391 Participants n=5 Participants	390 Participants n=7 Participants	781 Participants n=5 Participants
Age, Categorical >=65 years	563 Participants n=5 Participants	558 Participants n=7 Participants	1121 Participants n=5 Participants
Age, Continuous	65.5 years STANDARD_DEVIATION 11.1 • n=5 Participants	65.4 years STANDARD_DEVIATION 11.0 • n=7 Participants	65.47 years STANDARD_DEVIATION 11.04 • n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants	153 Participants n=7 Participants	304 Participants n=5 Participants
Sex: Female, Male Male	803 Participants n=5 Participants	795 Participants n=7 Participants	1598 Participants n=5 Participants
Region of Enrollment Germany	52 participants n=5 Participants	60 participants n=7 Participants	112 participants n=5 Participants
Region of Enrollment Spain	196 participants n=5 Participants	196 participants n=7 Participants	392 participants n=5 Participants
Region of Enrollment Italy	448 participants n=5 Participants	429 participants n=7 Participants	877 participants n=5 Participants
Region of Enrollment Hungary	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Netherlands	25 participants n=5 Participants	23 participants n=7 Participants	48 participants n=5 Participants
Region of Enrollment Belgium	18 participants n=5 Participants	22 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment France	61 participants n=5 Participants	62 participants n=7 Participants	123 participants n=5 Participants
Region of Enrollment Russian Federation	9 participants n=5 Participants	18 participants n=7 Participants	27 participants n=5 Participants
Region of Enrollment Saudi Arabia	45 participants n=5 Participants	45 participants n=7 Participants	90 participants n=5 Participants
Region of Enrollment Denmark	9 participants n=5 Participants	14 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment Finland	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment South Africa	32 participants n=5 Participants	24 participants n=7 Participants	56 participants n=5 Participants
Region of Enrollment Poland	22 participants n=5 Participants	14 participants n=7 Participants	36 participants n=5 Participants
Region of Enrollment Portugal	23 participants n=5 Participants	30 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: From enrollment to study completion or exit whichever occured first

Population: For the primary endpoint analysis, only patients with at least a device data record were considered.

Outcome measures

Outcome measures
Measure	NID 18/24 n=891 Participants standard number of interval to detect ventricular arrhythmias	NID 30/40 n=876 Participants Prolonged number of interval to detect ventricular arrhythmias
For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.	67.1 rate of therapies per 100 patient-years Interval 61.7 to 72.9	41.9 rate of therapies per 100 patient-years Interval 27.6 to 46.5

SECONDARY outcome

Timeframe: end of study

Outcome measures

Outcome data not reported

Adverse Events

Short NID

Serious events: 300 serious events

Other events: 0 other events

Deaths: 0 deaths

Long NID

Serious events: 258 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Laura Manotta

MEDTRONIC Clinical Research Institute

Phone: +39022413.1

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Short NID n=954 participants at risk Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia	Long NID n=948 participants at risk Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
Blood and lymphatic system disorders Thromboembolic Events	1.7% 16/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.84% 8/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders Lead Dislodgment	2.8% 27/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	2.1% 20/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders Worsening heart failure	10.0% 95/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	8.8% 83/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders System Dysfunction	0.10% 1/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.11% 1/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders Inappropriate Tachyarrhythmia Therapy	0.73% 7/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.53% 5/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Renal and urinary disorders Renal Failure	1.0% 10/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.84% 8/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Surgical and medical procedures Pocket Hematoma	0.31% 3/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.63% 6/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Surgical and medical procedures Post Surgical Infection	0.52% 5/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.32% 3/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders Acute Myocardial Infarction	0.94% 9/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	1.2% 11/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders Coronary Artery disease	0.73% 7/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.42% 4/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders Elevated Threshold	0.42% 4/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.11% 1/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders All cause syncope	0.94% 9/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	1.6% 15/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.63% 6/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.63% 6/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders Cardiogenic shock	0.31% 3/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.32% 3/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders Ventricular Arrhythmia	2.5% 24/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	2.3% 22/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Surgical and medical procedures epicardial LV implant	0.00% 0/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.11% 1/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Surgical and medical procedures Pericardial Effusion	0.10% 1/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.21% 2/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders Atrial Arrhthmias	2.3% 22/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	1.6% 15/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Surgical and medical procedures Pocket Infection	1.2% 11/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	1.8% 17/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders Angina	0.63% 6/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.53% 5/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders Extracardiac Stimulation	0.21% 2/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.32% 3/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Surgical and medical procedures Pneumothorax	0.10% 1/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.11% 1/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders Dyspnea	0.21% 2/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.42% 4/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
General disorders Neoplasia	2.0% 19/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.84% 8/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.21% 2/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.53% 5/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Surgical and medical procedures Device migration	0.10% 1/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.32% 3/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Blood and lymphatic system disorders hypotension	0.10% 1/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.11% 1/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Blood and lymphatic system disorders Hypertension	0.10% 1/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.11% 1/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Cardiac disorders bradycardia	0.10% 1/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.00% 0/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
Musculoskeletal and connective tissue disorders Musculoskeletal diseases	1.0% 10/954 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.	0.63% 6/948 • Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.