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Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation

NCT ID: NCT06330675

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2027-06-01

Brief Summary

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Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication. Due to the lack of guidelines available on the timing of postoperative mobilization management, the aim of the study is to evaluate the safety of early mobilization, comparing mobilization at 4-h against day-after procedure.

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Detailed Description

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Conditions

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Pacemaker Defibrillators, Implantable

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mobilization 4-h after procedure

Short-term bed-rest (4-h) after CIED implantation

Group Type EXPERIMENTAL

Early mobilization

Intervention Type OTHER

Short-term bed-rest and immobilization

Mobilization day-after procedure

Standard of care with prolungate bed-rest after CIED implantation

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Bed-rest and immobility until the day-after procedure

Interventions

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Early mobilization

Short-term bed-rest and immobilization

Intervention Type OTHER

Standard of care

Bed-rest and immobility until the day-after procedure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years old
* Signed informed consent form
* New permanent pacemaker implantation (PM) or implantable cardioverter-defibrillator (ICD)

Exclusion Criteria

* CIED implants after recent cardiac surgery
* Upgrade or revision of implanted device
* CRT implantation
* Intraoperative complications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiocentro Ticino

OTHER

Sponsor Role collaborator

Caporali Elena

OTHER

Sponsor Role lead

Responsible Party

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Caporali Elena

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Elena Caporali, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiocentro Ticino Institute - EOC

Locations

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Cardiocentro Ticino Institute - EOC

Lugano, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Elena Caporali, MD

Role: CONTACT

[email protected]
+41 (0)91 811 53 24

Michele Villa, RN

Role: CONTACT

[email protected]
+41 (0)91 811 50 59

Facility Contacts

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Elena Caporali, MD

Role: primary

Other Identifiers

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2022-01820

Identifier Type: -

Identifier Source: org_study_id

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