MAMma-ablation ECG study

MAMma-ablation ECG study - MAM ECG study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38789

Enrollment

Registered

2013-10-18

Start date

2013-10-01

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

electrocardiology

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All women who are scheduled for an elective ablation of the left breast are eligible to participate. Women who are scheduled for ablation of both breasts or who previously had an ablation of the right breast are also candidates for inclusion.

Exclusion criteria

Exclusion criteria: Women with ulcerating, late stage breast cancer will not be asked to participate. Prior CVD. Cardiovascular complaints.

Design outcomes

Primary

Measure	Time frame
The goal of this study is not to establish whether there is a significant difference between the ECG recorded before and after ablation, as there will be surely an effect, but to examine the nature of this change. Further, to identify to what extend the differences in ECG recordings between men and women are caused by differences in thorax geometry. For such a type of study it not possible to determine beforehand the sample size needed to obtain a significant result by power calculation (indeed, the phrase "significant" does not apply). In order to reach the goal of this study there is no need for a large sample size, but the size should be large enough to avoid a strong effect of possible outliers. Our aim is to include 30-40 women in this study. For each ECG/posture measurement a reconstructed body surface will be available. These reconstructions will be registered to enable: - Changes in breast tissue due to ablative surgery - Changes in electrode position for the subsequent follow up measurements. ECG analysis will take into account the changes in P-wave, QRS and T- wave morphology.	—

Measure

Time frame

The goal of this study is not to establish whether there is a significant difference between the ECG recorded before and after ablation, as there will be surely an effect, but to examine the nature of this change. Further, to identify to what extend the differences in ECG recordings between men and women are caused by differences in thorax geometry. For such a type of study it not possible to determine beforehand the sample size needed to obtain a significant result by power calculation (indeed, the phrase "significant" does not apply). In order to reach the goal of this study there is no need for a large sample size, but the size should be large enough to avoid a strong effect of possible outliers. Our aim is to include 30-40 women in this study. For each ECG/posture measurement a reconstructed body surface will be available. These reconstructions will be registered to enable: - Changes in breast tissue due to ablative surgery - Changes in electrode position for the subsequent follow up measurements. ECG analysis will take into account the changes in P-wave, QRS and T- wave morphology.

—

Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results