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Not yet recruiting NCT07494825

CIED Post-OR Rehabilitation

No phase Interventional CIED Postoperative Upper Limb Stiffness and Disability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: a systematic rehabilitation exercise program (rehabilitation exercise routine), regular guidance.
Who it may be relevant to
Registry conditions: CIED Postoperative Upper Limb Stiffness and Disability. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Construction of a Postoperative Upper Limb Rehabilitation Exercise System With Transvenous Leads for CIED Implantation and Its Safety and Effectiveness Verification

Overview

The purpose of this study is to develop a systematic rehabilitation exercise program (rehabilitation exercise routine), focusing on the rehabilitation training of the upper limb on the implantation side after transvenous cardiac implantable electronic devices (CIEDs) implantation, and to explore its impact on the joint function of the implanted upper limb and the overall quality of life of patients. This study will conduct long-term follow-up by comprehensively using imaging examinations and relevant professional assessment scales, focusing on evaluating the clinical safety of this rehabilitation exercise routine, and simultaneously clarifying its improvement effect on discomfort symptoms (such as pain, stiffness, etc.) and functional abnormalities of the implanted limb, so as to provide scientific basis and practical guidance for the standardized rehabilitation of patients after transvenous CIEDs implantation.

Interventions

  • Behavioral a systematic rehabilitation exercise program (rehabilitation exercise routine)
    a systematic rehabilitation exercise program (rehabilitation exercise routine)
  • Other regular guidance
    regular guidance

Primary outcome measures

  • Change in shoulder joint range of motion of the implanted upper limb after rehabilitation exercise intervention [Time frame: 3-month follow-up (compared with baseline preoperative data)]
  • Major safety endpoint - Composite of severe rehabilitation-related complications [Time frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)]
Secondary outcome measures (4)
  • Change in upper limb functional ability of the implanted upper limb [Time frame: 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)]
  • Change in pain level of the implanted upper limb [Time frame: Immediate postoperative (within 24 hours), 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)]
  • Change in quality of life [Time frame: 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)]
  • Minor safety endpoint - Incidence of rehabilitation-related adverse events [Time frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)]

Eligibility criteria

Inclusion criteria

  • Patients who meet the indications for transvenous CIEDs implantation in accordance with ACC/AHA/HRS or ESC guidelines, including single-chamber, dual-chamber, and triple-chamber pacemakers;
  • Patients who have previously implanted a transvenous pacemaker and plan to upgrade the pacemaker requiring the addition of electrode leads;
  • Patients aged > 18 years at the time of enrollment;
  • The subject (or the patient's legal authorized representative) is willing and able to sign their name and date on the patient informed consent form.

Exclusion criteria

  • Subjects aged ≤ 18 years old, pregnant women or lactating patients;
  • Patients with disease conditions that the researcher deems inappropriate for participation in this study;
  • Patients who have previously implanted a transvenous pacemaker and only need to replace the pulse generator;
  • Patients who are simultaneously participating in other clinical studies related to cardiac electronic implantable devices.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 1. Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009--a World Society of Arrhythmia's project. Pacing Clin Electrophysiol. 2011;34(8):1013-27. 2. Burri H, Starck C, Auricchio A, Biffi M, Burri M, D'Avila A, et al. EHRA expert consensus statement and practical guide on optimal implantation technique for conventional pacemak

Identifiers

NCT: NCT07494825 · CIEDrehabilitation2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗