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OpenTrials
Completed

NCT Number: NCT01230073

Treatment Satisfaction in Implantable Cardioverter Defibrillator Recipients

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Deutsches Hezzentrum

München, Bavaria, 80636, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-Monitoring

Device

Home-Monitoring

Follow-up by Home-Monitoring

Device

Follow-up by Home-Monitoring

Primary outcomes

  1. Treatment satisfaction with ICD therapy and follow-up

    Time frame: 12 months

Secondary outcomes

  1. Number of healthcare consultations

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Official study title

Treatment Satisfaction With Remote Monitoring in Implantable Cardioverter Defibrillator Recipients

Acronym: SAN REMO 2

Important dates

Study start
2011
Primary completion
2014
Study completion
2017
First posted
Oct 28, 2010
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.