Status:
UNKNOWN
Ablation of Low Voltage Regions in Persistent Atrial Fibrillation
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Abbott
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Background. Atrial fibrillation (AF) is a disorganised rhythm of the upper chambers of the heart. It can lead to severe complications including stroke or heart failure. It can be treated with radiofre...
Eligibility Criteria
Inclusion
- Suitable candidate for catheter mapping/ablation for arrhythmias.
- Eighteen (18) to eighty-five (85) years of age
- Body Mass Index (BMI) \< 40 (Wt. in Kgs / Ht. in m2)
- Signed Informed Consent
Exclusion
- Severe cerebrovascular disease
- Moderate to severe renal impairment (eGFR \< 30)
- Active gastrointestinal bleeding
- Active infection or fever
- Short life expectancy
- Significant anemia
- Severe uncontrolled systemic hypertension
- Severe electrolyte imbalance
- Ejection fraction of \< 35%
- Congestive heart failure (NYHA Class IV)
- Unstable angina requiring emergent PTCA (percutaneous transluminal coronary angioplasty) or CABG (coronary artery bypass graft)
- Recent myocardial infarction
- Bleeding or clotting disorders
- Uncontrolled diabetes
- Inability to receive IV or oral Anticoagulants
- Unable to give informed consent (these patients would not be recruited)
- Previous catheter or surgical ablation treatment for atrial fibrillation.
- Paroxysmal atrial fibrillation.
- Pregnancy (urinary pregnancy test will be offered on the day of the procedure for all women of reproductive age)
- Drug and/or alcohol abuse
- Transient factors for AF
- Severe LA enlargement of \>60 mm in diameter on echocardiography
- Patients who have participated in another study of an investigational medicinal product in the last 3 months.
Key Trial Info
Start Date :
August 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03811938
Start Date
August 24 2017
End Date
June 1 2020
Last Update
January 30 2019
Active Locations (1)
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1
Hammersmith Hospital
London, United Kingdom, W12 0HS