Improvement of Treatment SatisfactionPhase 4SAN REMO 2NCT01230073
Treatment Satisfaction in Implantable Cardioverter Defibrillator Recipients
A Phase 4 study testing Home-Monitoring and Follow-up by Home-Monitoring in people with Improvement of Treatment Satisfaction, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Improvement of Treatment Satisfaction
- What is being tested?
- Home-Monitoring and Follow-up by Home-Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ICD indication according to current national or international guidelines
- Patient available for follow-up during study period
Who cannot join
- Clinically unstable medical conditions that require regular outpatient clinic follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Satisfaction With Remote Monitoring 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.
- Conditions
- Improvement of Treatment Satisfaction
- Being tested
- Home-Monitoring, Follow-up by Home-Monitoring
- Keywords
- ICD, Home-Monitoring, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-MonitoringDevice
Home-Monitoring
Follow-up by Home-MonitoringDevice
Follow-up by Home-Monitoring
| Study group | Role | What they receive |
|---|---|---|
| ICD traditional follow-up | Active comparator | ICD with traditional follow-up in the outpatient clinic Receives: Device: Home-Monitoring; Device: Follow-up by Home-Monitoring |
| Home-Monitoring | Active comparator | Home-Monitoring Receives: Device: Home-Monitoring; Device: Follow-up by Home-Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment satisfaction with ICD therapy and follow-up
Measured: 12 months
Secondary outcomes (1)
Number of healthcare consultations
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startFeb 2011
- Primary completionJul 2014
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improvement of Treatment SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kolb Christof, Principal investigator, Deutsches Herzzentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230073
- Sponsor's protocol ID
- GER-EP-004
- Acronym
- SAN REMO 2
- Status last verified
- May 2018
- First submitted
- 26 Oct 2010
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Satisfaction With Remote Monitoring in Implantable Cardioverter Defibrillator Recipients
- ClinicalTrials.gov ID
- NCT01230073
- Acronym / sponsor ID
- SAN REMO 2 / GER-EP-004
- Conditions
- Improvement of Treatment Satisfaction
- Keywords
- ICD, Home-Monitoring, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICD traditional follow-up | Active comparator | Device: Home-Monitoring, Device: Follow-up by Home-MonitoringICD with traditional follow-up in the outpatient clinic |
| Home-Monitoring | Active comparator | Device: Home-Monitoring, Device: Follow-up by Home-MonitoringHome-Monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ICD indication according to current national or international guidelines
- Patient available for follow-up during study period
Key exclusion criteria (1 listed)
- Clinically unstable medical conditions that require regular outpatient clinic follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-MonitoringHome-Monitoring | Device | Home-Monitoring, ICD traditional follow-up |
| Follow-up by Home-MonitoringFollow-up by Home-Monitoring | Device | Home-Monitoring, ICD traditional follow-up |
Primary outcome
Treatment satisfaction with ICD therapy and follow-up
Time frame: 12 months
1 secondary outcome
Number of healthcare consultations
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kolb Christof principal investigator
Deutsches Herzzentrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Home-Monitoring and Follow-up by Home-Monitoring in people with Improvement of Treatment Satisfaction, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment satisfaction with ICD therapy and follow-up (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.