tility and safety of oral Flecainide (arrhythmia drug) in patients with atrial fibrillation after heart valve (mitral) surgery
Not Applicable
- Conditions
- Health Condition 1: null- Atrial fibrillation in patients who have undergone mitral valve replacement/ repair
- Registration Number
- CTRI/2017/10/010144
- Lead Sponsor
- Torrent Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients with rheumatic mitral valve disease who have undergone mitral valve replacement/ repair (3 to 6 months post surgery)
2.Patients > 15 years of age
3.Patients with chronic AF
4.Patients giving written informed consent
Exclusion Criteria
1.Patients intolerant of β blockers or Diltiazem or having a ventricular rate < 60/min
2.Patients with a LA > 60 mm in any diameter or LA volume > 216 cm3
3.Patients < 15 years of age or < 30 kg
4.Patients with LV dysfunction <= 40% or documented CAD
5.Inability to comply with the follow-up period
6.Patients not giving written consent for inclusion in the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maintenance of sinus rhythm at 6 monthsTimepoint: Maintenance of sinus rhythm at 6 months
- Secondary Outcome Measures
Name Time Method Occurrence of pro-arrhythmic events in patients receiving oral Flecainide therapyTimepoint: QRS duration will be monitored with standard/EASI derived 12 lead ECG at 25 and 50 mm/s speed prior to the first dose and then before every dose for a total of 3 doses. <br/ ><br>Patients will be followed up at 1 week, 3 months and 6 months. Holter monitoring will be done at or after 6 months in patients who are maintaining sinus rhythm.