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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42377
Enrollment
20
Registered
2015-07-17
Start date
2017-08-31
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure / pump failure

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
The primary study outcome will be the dataset collected by the hartmonitor during the conventional, invasive, pressure guided (dP/dt) optimalisation of the resynchronisation device. Which should lead to a usable algorhytm for optimizing resynchronisation pacing only using the hartmonitor in the futur.

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)