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Treatment Satisfaction in Implantable Cardioverter Defibrillator Recipients

NCT ID: NCT01230073

Last Updated: 2018-05-24

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2017-12-31

Brief Summary

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Remote monitoring of implantable cardioverter defibrillators (ICD) is a promising new development in ICD therapy and has been shown to be technically feasible and safe.While data on safety and feasibility of remote monitoring are in favour of this technology, patients´ treatment satisfaction has not been sufficiently investigated. To date, there is only one small, non-randomised study investigating patients´ treatment satisfaction in highly selected and highly motivated patients at the time of implantation and 12 months thereafter7. Therefore, the aim of the San Remo Trial is to investigate factors that are associated with patients´ willingness to accept the new method of follow-up on a broad basis of ICD recipients and to determine their treatment satisfaction with ICD therapy in a randomised, prospective trial.

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Detailed Description

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Conditions

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Improvement of Treatment Satisfaction

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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ICD traditional follow-up

ICD with traditional follow-up in the outpatient clinic

Group Type ACTIVE_COMPARATOR

Home-Monitoring

Intervention Type DEVICE

Home-Monitoring

Follow-up by Home-Monitoring

Intervention Type DEVICE

Follow-up by Home-Monitoring

Home-Monitoring

Home-Monitoring

Group Type ACTIVE_COMPARATOR

Home-Monitoring

Intervention Type DEVICE

Home-Monitoring

Follow-up by Home-Monitoring

Intervention Type DEVICE

Follow-up by Home-Monitoring

Interventions

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Home-Monitoring

Home-Monitoring

Intervention Type DEVICE

Follow-up by Home-Monitoring

Follow-up by Home-Monitoring

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ICD indication according to current national or international guidelines
* Patient available for follow-up during study period

Exclusion Criteria

* Clinically unstable medical conditions that require regular outpatient clinic follow-up
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kolb Christof

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum

Locations

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Deutsches Hezzentrum

München, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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GER-EP-004

Identifier Type: -

Identifier Source: org_study_id

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