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Heart FailurePhase 4OptiLink-HFNCT00769457

OptiLink HF Study: Optimization of Heart Failure Management Using Medtronic OptiVol Fluid Status Monitoring and CareLink Network

A Phase 4 study testing Access Arm in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients suffering from heart failure and a markedly reduced pumping capacity and sometimes desynchronization of the lower chambers of the heart have a higher risk of suffering sudden cardiac death. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Access Arm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,002 participants
Where
1 siteGermany
Study dates
Sep 2008to Nov 2014
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects have a Medtronic Virtuoso™ ICD single- or dual-chamber or Concerto™ CRT-D or subsequently market released Medtronic device providing at least the same functionality) implanted, including device replacement. Subjects with CRT-D must fulfill CRT-indication as described in the ESC guidelines for cardiac pacing and cardiac resynchronization therapy 2007: EF ≤ 35% and NYHA III, and LVEDD ≥ 55 mm, and QRS ≥ 120 ms, and optimized therapy
  • Subjects with stable chronic heart failure (CHF) in New York Heart Association (NYHA) class II or III for at least 30 days and left ventricular ejection fraction of no more than 35% (most recent measurement within 6 months prior to randomization by echocardiography or contrast ventriculography, magnetic resonance or nuclear imaging, based on local practice), on optimal target or maximal tolerated dose of ACE-inhibitors or angiotensin receptor blockers, ß-blockers and diuretics if clinically indicated to reduce fluid retention and one of the following criteria:
  • At least one hospitalization due to the heart failure within the last 12 months before enrollment
  • Or one course of ambulatory IV-or oral diuretic treatment or a BNP value of > 400 pg/ml or a NT-proBNP values > 450 in subject < 50 years, > 900 (50-75 years) and > 1800 subject of than 75 years old within 30 days of enrollment
  • Written informed consent by the subject for study participation prior to clinical investigation plan specific procedures,
  • The subject must be able and willing to comply with the clinical investigation plan and willing to remain available for follow-up visits to the study closure,
  • Subjects or the subject's caregiver must be willing and able to use the Medtronic CareLink® monitor as instructed and to perform the required duties, if subject is randomized to the access arm.

Who cannot join

  • Subjects with chronic renal failure needing renal dialysis
  • Subjects with serum creatinine > 2.5 mg/dl, measured within 14 days prior to enrollment,
  • Subjects with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) as determined by physician and documented in medical records (Stage III and Stage IV),
  • Subjects with suspected or confirmed COPD require a current test of lung function (not more than 12 months before inclusion). If the "forced expiratory volume" is <1.0 L/sec,the subject may not participate in the study,
  • Subjects on the heart transplantation list or subjects with transplanted hearts,
  • Subjects listed for valve replacement or interventional valve therapy,
Show all 16Show fewer
  • Subjects with myocardial infarction within the last 40 days before implant. MI is defined by typical changes in biochemical markers including troponin levels > 3 times the upper limits of normal and creatinine kinase < 2 times of upper limit, or with CKMB greater than the upper limit of normal, combined (for all enzymes) with at least one of the following ischemic symptoms, ECG changes consistent of diagnostic ST-T wave changes or pathologic Q waves or new LBBB,
  • Subjects with stroke within 40 days prior randomization,
  • Subjects who have had a percutaneous coronary intervention within 3 months prior to randomization,
  • Subjects with cardiac surgery within 90 days of randomization,
  • Subjects with complex and uncorrected Congenital Heart Disease,
  • Subject's life expectancy is less than 18 months in the opinion of the physician,
  • Subjects in situations that would limit participation, not eligible to receive a CareLink® monitor (e.g. hearing or speech impaired with no family member or caregiver available to assist, or those who spend extended periods abroad, or those who intend to enroll in a study that would preclude use of the monitor),
  • Subject is participating in a concurrent intervention study,
  • Subject or the subject's caregiver is unwilling to give consent for the release of information for the evaluation or to give additional consent for the release of subject medical and privacy data for CareLink® subjects,
  • Subjects with exclusion criteria required by local law (age < 18, women who are pregnant or breastfeeding)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsklinikum des Saarlandes

    Homburg-Saar, Saarland, 66424

Other trials in Germany

About this study

Official title: OptiLink HF Study (Optimization of Heart Failure Management Using Medtronic OptiVol® Fluid Status Monitoring and Medtronic CareLink® Network)

Patients suffering from heart failure and a markedly reduced pumping capacity and sometimes desynchronization of the lower chambers of the heart have a higher risk of suffering sudden cardiac death.

These patients can be treated with an Implantable Cardiac Defibrillator that terminates dangerously fast heartbeats and in case of asynchronous pumping of the heart can also re-synchronize the lower chambers of the heart (ICD- or CRT-D-system). Patients that moreover suffered from a worsening of their cardiac status (cardiac decompensation) and had to be hospitalized for this reason have a higher risc to have following decompensations. New technology, incorporated into modern Medtronic ICD- and CRT-D-Systems, that measures the amount of water in the lungs is able to warn before such a dangerous worsening occurs. If coupled with modern data transmitting technology (CareLink), automatic information in case of a worsening of the cardiac status can be sent to caregivers, who in turn can react timely in order to prevent a worsening an subsequent hospitalization.

The study examines to which extent this new technology prevents potentially adverse cardiac situations and / or hospitalizations and has an influence of the duration of patient´s lives.

Read the detailed description

The objective of the study is to establish whether the use of event-triggered HF-disease management through Medtronic's OptiVol® fluid status monitoring with an automatically generated wireless CareAlert® notification of the clinician via the Medtronic CareLink® Network can reduce cardiovascular related hospitalizations and the number of deaths in a subject population with HF and ICD / CRT-D treatment as compared to standard clinical assessment. As a measure for the reduction of hospitalizations and deaths the rate of all cause deaths or cardiovascular related hospitalizations will be determined.

Conditions
Heart Failure
Being tested
Access Arm
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Access ArmDevice

    Also called Medtronic CRT-D and ICD-VR / DR with OptiVol, Conexus-Telemetry, CareLink:, Concerto , Consulta , Virtuoso , Secura , Protecta XT

    Active OptiVol-System with CareAlert via CareLink

Study groups in NCT00769457
Study groupRoleWhat they receive
1ExperimentalArm with activated OptiVol / Carelink-system, event-triggered physician alert and physician access to Cardiac Compass data
Receives: Device: Access Arm
2No interventionArm with standard ICD - CRT-D therapy, no OptiVol and no Carelink

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause of death or unplanned admission to hospital for cardiovascular reason from day of patient informed consent sign off

    Measured: 18 Months

Secondary outcomes (1)

  1. Number of HF-related hospitalization during follow-up, HF-related hospitalization, Sum of follow-up days minus days alive and out of the hospital, All cause mortality, Cardiovascular Mortality,

    Measured: 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,002 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00769457
Sponsor's protocol ID
CEN_G_CA_8
Acronym
OptiLink-HF
Status last verified
May 2016
First submitted
8 Oct 2008
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Brachmann J, Bohm M, Rybak K, Klein G, Butter C, Klemm H, Schomburg R, Siebermair J, Israel C, Sinha AM, Drexler H; OptiLink HF Study Executive Board and Investigators. Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink). Eur J Heart Fail. 2011 Jul;13(7):796-804. doi: 10.1093/eurjhf/hfr045. Epub 2011 May 8.

    PubMed 21555324

  • Bohm M, Drexler H, Oswald H, Rybak K, Bosch R, Butter C, Klein G, Gerritse B, Monteiro J, Israel C, Bimmel D, Kaab S, Huegl B, Brachmann J; OptiLink HF Study Investigators. Fluid status telemedicine alerts for heart failure: a randomized controlled trial. Eur Heart J. 2016 Nov 1;37(41):3154-3163. doi: 10.1093/eurheartj/ehw099. Epub 2016 Mar 16.

    PubMed 26984864

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Access Arm in people with Heart Failure, 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 7 inclusion and 16 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.

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?

All-cause of death or unplanned admission to hospital for cardiovascular reason from day of patient informed consent sign off (time frame: 18 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 NCT00769457, 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.

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