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BIO|CREATE: Pilot Study to Investigate the Creation of Physiological Rhythm by Closed Loop Stimulation in hEart Failure pAtients With chronoTropic incompEtence

Sponsor
Biotronik SE & Co. KG (Industry)
Overall Status
Completed
CT.gov ID
NCT03157076
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
24.3
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study assesses the effect of Closed Loop Stimulation (CLS) on the ventilatory efficiency slope and estimates the patient responder rate to CLS in patients with severe chronotropic incompetence treated with a cardiac resynchronization therapy (CRT) device.

Condition or Disease Intervention/Treatment Phase
  • Device: Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS)
 N/A

Detailed Description

In patients with pharmacological refractory heart failure (HF), systolic dysfunction, and cardiac dyssynchrony, the cardiac resynchronization therapy (CRT) reduces the risk of death, and improves symptoms and quality of life.

A considerable portion (80%) of patients with a CRT indication has a chronotropic incompetence (CI). CI usually induces a stress intolerance which negatively affects the quality of life. In addition of being a marker of diminished exercise capacity, severe CI (sCI) may be an independent predictor of mortality.

The sensor-based rate adaption provided by the implanted CRT device delivers a possible therapeutic approach for the CI.

Usually, rate adaption is achieved by an accelerometer. The previous studies in terms of effectiveness of rate adaption in CRT patients with CI showed inconsistent results.

In addition to an accelerometer to deliver the rate adaption BIOTRONIK provides closed loop stimulation (CLS) as unique feature in a CRT device. CLS determines the appropriate heart rate based on intra-cardiac impedance measurements. These measurements reflect changes of the cardiac contraction dynamics in reaction to information coming from the autonomic nervous system. CLS takes the information on the contraction dynamics and translates it into an adequate heart rate adaptation, thus delivering physiologically appropriate therapy.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Patients are randomized in two different pacing modes (CLS versus intrinsic rhythm) after one month after enrollment. The cross-over takes place after one month after the randomization.Patients are randomized in two different pacing modes (CLS versus intrinsic rhythm) after one month after enrollment. The cross-over takes place after one month after the randomization.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
BIO|CREATE Pilot Study
Actual Study Start Date :
Apr 19, 2017
Actual Primary Completion Date :
Mar 31, 2019
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pacing mode with CLS

Device: Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS)
The feature CLS will be programmed ON or Off according to a randomization list after one month after baseline visit. One month later the alternate will be programmed.
Other Names:
  • Cardiac Resynchronization therapy device without Closed Loop Stimulation (CLS)

    		•
    Active Comparator: Intrinsic mode

    Device: Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS)
    The feature CLS will be programmed ON or Off according to a randomization list after one month after baseline visit. One month later the alternate will be programmed.
    Other Names:
  • Cardiac Resynchronization therapy device without Closed Loop Stimulation (CLS)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ventilatory efficiency slope [2 months]

      The slope of VE/VCO2 describes the ventilatory efficiency during effort, showing the amount of air that must be ventilated to eliminate 1 litre of CO2.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • CRT class I indication at time of implantation, according to current guidelines

    • Implantation of CRT-device including CLS > 6 months prior to enrollment

    • Stable heart failure status for at least 1 month

    • Optimal cardiovascular drug treatment according to current guidelines

    • NYHA class II or III

    • Patient is able to comply with the protocol

    • Patient provided written informed consent

    • Stable location of residence

    Exclusion Criteria:

    • Planned cardiovascular intervention within the next 3 months

    • Admission for decompensated heart failure or acute coronary syndrome in the preceding 3 months

    • Ongoing symptoms of myocardial ischemia

    • Known persistent, long-standing persistent or permanent atrial fibrillation

    • COPD with GOLD ≥ 3

    • Planned absence of residence for more than one week during study period

    • Pregnant or breast-feeding women

    • Participation in another interventional clinical investigation

    • Age < 18 years

    • Placed in an institution due to official decree or judicial order

    • Dependent from the sponsor, the clinical site or the investigators

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité Universitätsklinikum - Campus Benjamin Franklin Berlin Germany

    Sponsors and Collaborators

    • Biotronik SE & Co. KG

    Investigators

    • Principal Investigator: Mattias Roser, Dr., Charité Universitätsklinikum - Campus Benjamin Franklin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biotronik SE & Co. KG
    ClinicalTrials.gov Identifier:
    NCT03157076
    Other Study ID Numbers:
    • CR019
    First Posted:
    May 17, 2017
    Last Update Posted:
    May 24, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of May 24, 2019