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

NCT00769457 | Completed Phase 4 DMC

• 1 other identifier: CEN_G_CA_8
• Study Type: interventional
• Target: 1,002
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

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

  18 Months

Secondary Outcomes (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,

  18 Months

Study Arms (2)

1

EXPERIMENTAL

Arm with activated OptiVol / Carelink-system, event-triggered physician alert and physician access to Cardiac Compass data

Device: Access Arm

2

NO INTERVENTION

Arm with standard ICD - CRT-D therapy, no OptiVol and no Carelink

Interventions

Access Arm DEVICE

Active OptiVol-System with CareAlert via CareLink

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 on the heart transplantation list or subjects with transplanted hearts,
• Subjects listed for valve replacement or interventional valve therapy,
• 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,

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (1)

Universitätsklinikum des Saarlandes

Homburg-Saar, Saarland, 66424, Germany

Location

Related Publications (2)

• 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.

  PMID: 21555324 BACKGROUND

• 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.

  PMID: 26984864 RESULT

Related Links

• Klinik für Innere Medizin III - Kardiologie, Angiologie und internistische Intensivmedizin

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael Boehm, Professor

  Universitätsklinikum des Saarlandes, Homburg-Saar

  PRINCIPAL INVESTIGATOR

• Johannes Brachmann, Professor

  Klinikum Coburg GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 3, 2025

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)