Trial Outcomes & Findings for Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices (NCT NCT01369706)

Results Overview

inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

388 participants

Primary outcome timeframe

time during exposure to hand-held metal detector (2x 30 sec)

Results posted on

2017-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Hand-held Metal Detector Exposure to two hand-held metal detectors Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)
Overall Study STARTED	388
Overall Study COMPLETED	388
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hand-held Metal Detector n=388 Participants Exposure to two hand-held metal detectors Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)
Age, Continuous	66 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants
Sex: Female, Male Male	295 Participants n=5 Participants
Region of Enrollment Greece	71 participants n=5 Participants
Region of Enrollment Germany	317 participants n=5 Participants

PRIMARY outcome

Timeframe: time during exposure to hand-held metal detector (2x 30 sec)

Population: Electromagnetic interference

inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function

Outcome measures

Outcome measures
Measure	Hand-held Metal Detector n=388 Participants Exposure to two hand-held metal detectors Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)
Electromagnetic Interference	0 participants

Adverse Events

Hand-held Metal Detector

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Christof Kolb

Deutsches Herzzentrum München

Phone: +49891218

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place