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Sub-project: Use of Small Implantable ECG Recorder in Pregnant Women With Arrhythmia (REVEAL)

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ClinicalTrials.gov Identifier: NCT02249195
Recruitment Status : Unknown
Verified September 2014 by Prof. Karen Sliwa-Hahnle, University of Cape Town.
Recruitment status was:  Recruiting
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. Karen Sliwa-Hahnle, University of Cape Town

Brief Summary:
Study will recruit pregnant or postpartum women presenting to Groote Schuur Hospital with cardiovascular disease in 20 consecutive patients and will insert an implantable ECG monitoring device. The patient will then be followed up over a duration of two year and will be monitored for arrhythmia and mortality.

Condition or disease
Arrhythmias in Pregnancy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Sub-project: Use of Small Implantable ECG Recorder in Pregnant Women With Arrhythmia
Study Start Date : June 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia




Primary Outcome Measures :
  1. arrhythmia [ Time Frame: Two years ]
    abnormal cardiac rhythm on ECG


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Two years ]
    All cause mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients will be recruited via a single-centre, prospective study of women with cardiovascular disease presenting pre- or postpartum, attending Groote Schuur Hospital. Since 1 July 2010, these patients have been seen at a weekly clinic, jointly run by cardiologists and obstetricians, under the leadership of Prof. Karen Sliwa and Prof John Anthony. We see about 100 new patients presenting with cardiovascular disease in pregnancy per annum. About 200 newly diagnosed pregnant women with documented or suspected cardiovascular disease will be screened for the indication to insert a REVEAL device. Those patients will be part of an ongoing registry entitled: Registry of newly diagnosed cases with cardiac disease in maternity-Phase II ( CDM-2).
Criteria

Inclusion Criteria:

  • Pregnant or postpartum women presenting to Groote Schuur Hospital with cardiovascular disease.

Exclusion Criteria:

-Individuals with structural heart disease.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249195


Contacts
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Contact: Karen Sliwa-Hahnle, PhD 0027216501735
Contact: Olivia Briton 0027214066088

Locations
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South Africa
University of Cape Town Recruiting
Cape Town, Western Cape, South Africa, 7925
Contact: Karen Sliwa-Hahnle, PhD    0027216501735      
Contact: Olivia Briton    0027214066088      
Sponsors and Collaborators
University of Cape Town
Investigators
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Principal Investigator: Karen Sliwa-Hahnle, PhD University of Cape Town
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Karen Sliwa-Hahnle, Professor, University of Cape Town
ClinicalTrials.gov Identifier: NCT02249195    
Other Study ID Numbers: REVEAL
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Prof. Karen Sliwa-Hahnle, University of Cape Town:
ECG loop recorder, pregnant women, arrhythmias
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes