Continuing versus stopping heart rhythm medication after an operation restoring your normal heart rhythm in patients with a heart rhythm disorder: a study across multiple hospitals.
- Conditions
- Symptomatic persistent atrial fibrillation: atrial fibrillation, that lasts longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more. Episodes of atrial fibrillation have to be accompanied by symptoms.MedDRA version: 20.0 Level: LLT Classification code 10071667 Term: Persistent atrial fibrillation System Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-002103-33-FR
- Lead Sponsor
- AZ Sint-Jan Brugge-Oostende AV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 220
1. Patient with symptomatic persistent AF, resistant to ongoing or prior ADT (failed ADT)
Patients is considered to have persistent AF if the patient has suffered any prior AF episode =7 days (ESC 2016 guidelines).
2. Before PVI, there was at least one episode of persistent AF in the last year.
3. Signed Patient Informed Consent Form.
4. Age 18 years or older.
5. Able and willing to comply with all follow-up testing and requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 160
1. Patients not willing or not suited to take any class IC or III ADT.
2. Any prior AF episode =12 months, or any recurrence of AF <3 days after cardioversion.
3. Presence of structural heart disease on echo criteria:
severe valvular heart disease
LA size >50mm
LV ejection fraction <35% (except if suspected tachycardiomyopathy)
septal diameter >15mm
4. BMI >35
5. Recent (<3 months) CABG, myocardial infarction, CVA, uncontrolled heart failure or angina
6. Active illness or systemic infection or sepsis
7. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
8. Awaiting cardiac transplantation or other cardiac surgery
9. Documented left atrial thrombus or atrial myxoma on imaging
10. History of blood clotting or bleeding abnormalities
11. Enrollment in any other study evaluating another device or drug
12. Women with childbearing potential
13. Life expectancy less than 12 months
14. Contraindication for catheter ablation (intramural thrombus, tumor or other abnormality that precludes catheter introduction, contraindication to anticoagulation therapy)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method