Treatment Satisfaction in Implantable Cardioverter Defibrillator Recipients
SAN REMO 2
Treatment Satisfaction With Remote Monitoring in Implantable Cardioverter Defibrillator Recipients
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2010
CompletedFirst Posted
Study publicly available on registry
October 28, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 24, 2018
May 1, 2018
3.4 years
October 26, 2010
May 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment satisfaction with ICD therapy and follow-up
12 months
Secondary Outcomes (1)
Number of healthcare consultations
12 months
Study Arms (2)
ICD traditional follow-up
ACTIVE COMPARATORICD with traditional follow-up in the outpatient clinic
Home-Monitoring
ACTIVE COMPARATORHome-Monitoring
Interventions
Follow-up by Home-Monitoring
Eligibility Criteria
You may qualify if:
- ICD indication according to current national or international guidelines
- Patient available for follow-up during study period
You may not qualify if:
- Clinically unstable medical conditions that require regular outpatient clinic follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Deutsches Hezzentrum
München, Bavaria, 80636, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Kolb Christof
Deutsches Herzzentrum
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2010
First Posted
October 28, 2010
Study Start
February 1, 2011
Primary Completion
July 1, 2014
Study Completion
December 1, 2017
Last Updated
May 24, 2018
Record last verified: 2018-05