Clinical Study to analyse safety, effectiveness and efficiency of new EVIA pacemaker family during routine pacemaker follow up after implantation.

REgistry for PaceMakers Offering Therapy Enhancement EVIA - REMOTE-EVIA

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2011/05/001746

Enrollment

1500

Registered

2011-05-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Bradyarrhythmia

Interventions

Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. The patient is willing and able to comply with the clinical investigation plan and has provided written informed consent. 2. EVIA pacemaker implantation performed within 6 weeks prior to enrollment.

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years. 2. Participation in another clinical study.

Design outcomes

Primary

Measure	Time frame
Number of (Serious) pacemaker - related Adverse Device EffectsTimepoint: 12 +/- 2 Months	—

Secondary

Measure	Time frame
Calculated battery lifetime and benefit of this tool based on the investigators judgmentTimepoint: 12 +/- 2 Months;Differences between automatic, manual, and initial data after pacemaker interrogation of P/R wave amplitude, A/V threshold and A/V lead impedance dataTimepoint: 12 +/- 2 Months;Number of patients with successful A/V Capture Control during the studyTimepoint: 12 +/- 2 Months;Number of patients without additional automatic and/or manual avaluation of sensing, threshold, and lead Impedance data after pacemaker interrogationTimepoint: 12 +/- 2 Months;Percentage of ventricular pacing with respect to the programming in two-chamber pacemakers: AV dalay, IRS plus, DDD(R)-ADI(R)mode/ Vp suppressionTimepoint: 12 +/- 2 Months;Producing the intended results based on the investigators judgment: A/V Auto Sensing, A/V Capture Control, Vp suppression/ DDD(R)-ADI(R) mode, IRS plus, Home Monitoring service center III & traffic light concept, IEGM-online HDTimepoint: 12 +/- 2 Months;Saving of time based on the investigators judgment: A/V Sensing, A/V Capture, Control, Vp suppression/ DDD(R)-ADI(R) mode, IRS plus, Home Monitoring service cente III & traffic light concept, IEGM-online HDTimepoint: 12 +/- 2 Months	—

Measure

Time frame

Calculated battery lifetime and benefit of this tool based on the investigators judgmentTimepoint: 12 +/- 2 Months;Differences between automatic, manual, and initial data after pacemaker interrogation of P/R wave amplitude, A/V threshold and A/V lead impedance dataTimepoint: 12 +/- 2 Months;Number of patients with successful A/V Capture Control during the studyTimepoint: 12 +/- 2 Months;Number of patients without additional automatic and/or manual avaluation of sensing, threshold, and lead Impedance data after pacemaker interrogationTimepoint: 12 +/- 2 Months;Percentage of ventricular pacing with respect to the programming in two-chamber pacemakers: AV dalay, IRS plus, DDD(R)-ADI(R)mode/ Vp suppressionTimepoint: 12 +/- 2 Months;Producing the intended results based on the investigators judgment: A/V Auto Sensing, A/V Capture Control, Vp suppression/ DDD(R)-ADI(R) mode, IRS plus, Home Monitoring service center III & traffic light concept, IEGM-online HDTimepoint: 12 +/- 2 Months;Saving of time based on the investigators judgment: A/V Sensing, A/V Capture, Control, Vp suppression/ DDD(R)-ADI(R) mode, IRS plus, Home Monitoring service cente III & traffic light concept, IEGM-online HDTimepoint: 12 +/- 2 Months

—

Countries

Austria, Belgium, Czech Republic, Denmark, Germany, India, Sweden, Switzerland, United Kingdom

Contacts

Public ContactMr Prabhas Goswami

Vibgyor Scientific Research Pvt Ltd.

bina.naik@vibgyorcare.com917926565076

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026