se of small implantable ECG recorder in women with peripartum cardiomyopathy
Not Applicable
- Conditions
- Circulatory System
- Registration Number
- PACTR202104866174807
- Lead Sponsor
- Medtronic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
Patients with a confirmed diagnosis of PPCM
- Age greater than 18 years
- Patients willing and able to give informed consent
- Patient is able (in the investigators’ opinion) to comply with all study requirements and return for follow-up
Exclusion Criteria
- Patients who are unable to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the burden of arrhythmias occurring in PPCM by means of ambulatory ECG monitoring by 24h Holter and ILR
- Secondary Outcome Measures
Name Time Method 1. To document incidence of life-threatening arrhythmias as detected by Holter monitoring versus implantable loop recorder (amongst those with an LVEF = 35% vs > 35%). 2. To document atrial tachyarrhythmia’s (atrial fibrillation, atrial flutter) to identify potential candidates for anticoagulation.<br>3. To determine average heart rate and the burden of sinus tachycardia on Holter monitoring (amongst those with an LVEF = 35% vs > 35%).