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Optimizing cardiac resynchronization therapy with the use of an implantable heart monitor

Completed
Conditions
10019280
heart failure / pump failure
Registration Number
NL-OMON42377
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

*Class I or IIa criteria of the 'European Society of Cardiology' for cardiac resynchronisation.
*Class III heart failure according to the 'New York Heart Association' with a hospitalization for hartfailure in the previous year.
*Willing and able to understand and comply with the study requirements and providing a signed informed consent.

Exclusion Criteria

*Under aged.
*Pregnant.
*Expected to undergo cardiac surgery in the near future.
*Permanent atrial fibrillation.
*Already having a cardiac resynchronisation device implanted previously.
*Pulmonary embolism in the prior 6 months or repeatedly in their lifetime.
*Cerebrovascular incident (CVA or TIA) in the previous 6 months.
*History of clotting or bleeding disorders (i.e. hyper- and hypocoagulability).

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary study outcome will be the dataset collected by the hartmonitor<br /><br>during the conventional, invasive, pressure guided (dP/dt) optimalisation of<br /><br>the resynchronisation device. Which should lead to a usable algorhytm for<br /><br>optimizing resynchronisation pacing only using the hartmonitor in the futur. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Not applicable.</p><br>
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