Change in Heart Rate Variability Prior to Tachyarrhythmia in ICD Implanted Patients

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To investigate changes in HRV during the time before a spontaneous episode of ventricular tachyarrhythmia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventricular Tachyarrhythmia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ICD ICD implanted patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observation

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* S/P lexos VR/-T,DR/-T implantation
* Signed patient informed consent

Exclusion Criteria

* CAF
* Life expectancy\<6 months
* Impending heart transplant
* Persistent recurring tachycardia
* Rhythm disturbances that preclude a meaningful HRV analysis
* Participation in another study.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Michael Glikson

Director , Davidai Arrhythmia Center, Leviev Heart Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Glikson, MD

Role: PRINCIPAL_INVESTIGATOR

SHEBA MC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arrythmia Service Center

Ramat Gan, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SHEBA-4743-07-MG-CTIL

Identifier Type: -

Identifier Source: org_study_id