Heart FailureConnectOptiVolNCT00730548
Compare Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Effect on Heart Failure
A study testing Device triggered remote telephone contact because of Care Alert in people with Heart Failure and Ventricular Tachycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Germany.
Trial summary
This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ventricular Tachycardia, Cardiac Desynchronization
- What is being tested?
- Device triggered remote telephone contact because of Care Alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Aug 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Implantation of a market-approved Medtronic Connexus CRT-D- or DR-ICD-device
- Patient consents to study
- Ability to replace follow-ups with CareLink follow-ups
- Ability to attend all follow-ups at study center
Who cannot join
- Permanent AF
- Less than 18 years of age
- Life expectancy less than 15 months
- Participation in another clinical study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation to Assess the Effect of the Combination of a Pre-Defined Management Pathway to Reduce Fluid Overload in Cardiac Decompensation With Carelink Remote Management, Connexus Remote Telemetry and the OptiVol Early Warning System on Health Care Utilization
This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).
- Being tested
- Device triggered remote telephone contact because of Care Alert
- Medical subject headings
- Heart Failure, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device triggered remote telephone contact because of Care AlertBehavioural
Also called OptiVol, CareLink, Medtronic Concerto, Medtronic Consulta
Care Alerts on, physician will be notified in case of an Care Alert. Depending on the outcome of the telephone contact drug adjustment and / or further interventions can be prescribed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Remote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON Receives: Behavioral: Device triggered remote telephone contact because of Care Alert |
| 2 | No intervention | No Care Alerts available, standard treatment of the patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first hospitalization due to worsened heart failure
Measured: 15 months
Secondary outcomes (1)
Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionApr 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Markus Zabel, MD, Principal investigator, University Hospital of Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730548
- Sponsor's protocol ID
- CEN_G_CA_7
- Acronym
- ConnectOptiVol
- Status last verified
- Feb 2017
- First submitted
- 19 Jun 2008
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zabel M, Vollmann D, Luthje L, Seegers J, Sohns C, Zenker D, Hasenfuss G. Randomized Clinical evaluatiON of wireless fluid monitoriNg and rEmote ICD managemenT using OptiVol alert-based predefined management to reduce cardiac decompensation and health care utilization: the CONNECT-OptiVol study. Contemp Clin Trials. 2013 Jan;34(1):109-16. doi: 10.1016/j.cct.2012.10.001. Epub 2012 Oct 13.
PubMed 23073567Luthje L, Vollmann D, Seegers J, Sohns C, Hasenfuss G, Zabel M. A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices. Europace. 2015 Aug;17(8):1276-81. doi: 10.1093/europace/euv039. Epub 2015 May 17.
PubMed 25983310
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation to Assess the Effect of the Combination of a Pre-Defined Management Pathway to Reduce Fluid Overload in Cardiac Decompensation With Carelink Remote Management, Connexus Remote Telemetry and the OptiVol Early Warning System on Health Care Utilization
- ClinicalTrials.gov ID
- NCT00730548
- Acronym / sponsor ID
- ConnectOptiVol / CEN_G_CA_7
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Nov 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 Aug 2008 (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.
This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Device triggered remote telephone contact because of Care AlertRemote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON |
| 2 | No intervention | –No Care Alerts available, standard treatment of the patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Implantation of a market-approved Medtronic Connexus CRT-D- or DR-ICD-device
- Patient consents to study
- Ability to replace follow-ups with CareLink follow-ups
- Ability to attend all follow-ups at study center
Key exclusion criteria (5 listed)
- Permanent AF
- Less than 18 years of age
- Life expectancy less than 15 months
- Participation in another clinical study
- Pregnancy
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 |
|---|---|---|
| Device triggered remote telephone contact because of Care AlertAlso: OptiVol, CareLink, Medtronic Concerto, Medtronic ConsultaCare Alerts on, physician will be notified in case of an Care Alert. Depending on the outcome of the telephone contact drug adjustment and / or further interventions can be prescribed | Behavioural | 1 |
Primary outcome
Time to first hospitalization due to worsened heart failure
Time frame: 15 months
1 secondary outcome
Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making
Time frame: 15 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 3 Jul 2025.
- Background: PubMed 23073567Zabel M, Vollmann D, Luthje L, Seegers J, Sohns C, Zenker D, Hasenfuss G. Randomized Clinical evaluatiON of wireless fluid monitoriNg and rEmote ICD managemenT using OptiVol alert-based predefined management to reduce cardiac decompensation and health care utilization: the CONNECT-OptiVol study. Contemp Clin Trials. 2013 Jan;34(1):109-16. doi: 10.1016/j.cct.2012.10.001. Epub 2012 Oct 13.
- Results publication: PubMed 25983310Luthje L, Vollmann D, Seegers J, Sohns C, Hasenfuss G, Zabel M. A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices. Europace. 2015 Aug;17(8):1276-81. doi: 10.1093/europace/euv039. Epub 2015 May 17.
- Individual participant dataSharing planned: No
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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.
Markus Zabel, MD principal investigator
University Hospital of Goettingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device triggered remote telephone contact because of Care Alert in people with Heart Failure and Ventricular Tachycardia, run by Medtronic Cardiac Rhythm and Heart Failure 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 4 inclusion and 5 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 3 Jul 2025. 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.
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?
Time to first hospitalization due to worsened heart failure (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00730548, which also lists 2 linked publications.
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 3 Jul 2025.