Trial Outcomes & Findings for Full Automaticity and Remote Follow-up (NCT NCT01526629)

NCT ID: NCT01526629

Last Updated: 2025-07-02

Results Overview

Evaluate the percentage of patients who had a successful remote follow up, as an alternative to onsite visit for patients implanted with a fully automatic ICD

• Recruitment status: COMPLETED
• Target enrollment: 354 participants
• Primary outcome timeframe: 13 months
• Results posted on: 2025-07-02

Participant Flow

Participant milestones

Measure	ICD Patients With Remote Follow-up Patients implanted with a fully automatic ICD and remotely followed-up.
Overall Study STARTED	354
Overall Study COMPLETED	308
Overall Study NOT COMPLETED	46

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Full Automaticity and Remote Follow-up

Baseline characteristics by cohort

Measure	ICD Patients With Remote Follow-up n=354 Participants Patients implanted with a fully automatic ICD and remotely followed-up.
Age, Customized Men	65 years n=5 Participants
Age, Customized Women	56 years n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	288 Participants n=5 Participants
Region of Enrollment France	354 participants n=5 Participants

PRIMARY outcome

Timeframe: 13 months

Evaluate the percentage of patients who had a successful remote follow up, as an alternative to onsite visit for patients implanted with a fully automatic ICD

Outcome measures

Measure	ICD Patients With Remote Follow-up n=308 Participants Patients implanted with a fully automatic ICD and remotely followed-up.
Remote Follow-up as an Alternative to Onsite Visit	203 Participants

Adverse Events

ICD Patients With Remote Follow-up

Serious events: 75 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	ICD Patients With Remote Follow-up n=354 participants at risk Patients implanted with a fully automatic ICD and remotely followed-up.
General disorders Death	2.8% 10/354
Cardiac disorders Ventricular arrhytmias	2.5% 9/354
Cardiac disorders Cardiac decompensation	4.0% 14/354
Cardiac disorders Atrial arrhytmias	1.7% 6/354
Skin and subcutaneous tissue disorders Infection or pocket hematoma	1.4% 5/354
Cardiac disorders Event of aggravation	1.7% 6/354
Cardiac disorders cardiovascular procedures	1.1% 4/354
Cardiac disorders cardiovascular complication	1.4% 5/354
General disorders Non cardiovascular causes	3.4% 12/354
Injury, poisoning and procedural complications Integrity default of material components	1.1% 4/354

Other adverse events

Adverse event data not reported

Additional Information

Latifa Foudali

Medtronic

Phone: 0155381700

Email: latifa.foudali@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place