Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01891058
Eligibility Criteria:
Inclusion Criteria:
* include stable (see below) patients presenting with an episode of RAFF of at least 3 hours duration,
* where symptoms require urgent management and where pharmacological or DC cardioversion is a reasonable option because there is a clear history of:
* onset within 48 hours, or
* onset within 7 days and adequately anticoagulated for \> 4 weeks (warfarin and INR \> 2.0 or newer oral anticoagulants \[dabigatran, rivaroxaban, and apixaban\]), or
* onset within 7 days and no left atrial thrombus on TEE. Of note, Investigators will not exclude patients with prior episodes of RAFF.
Exclusion Criteria:
Investigators will exclude patients for the reasons listed below.
* who are unable to give consent;
* who have permanent (chronic) AF;
* whose episode did not clearly start within 48 hours \[or 7 days if anticoagulated / normal TEE\];
* who are deemed unstable and require immediate cardioversion: i) systolic blood pressure \<100 mmHg; ii) rapid ventricular preexcitation (Wolff-Parkinson-White syndrome); iii) acute coronary syndrome - chest pain and acute ischemic changes on ECG; or iv) pulmonary edema - severe dyspnea requiring immediate IV diuretic, nitrates, or BIPAP;
* whose primary presentation was for another condition; examples include pneumonia, pulmonary embolism, and sepsis;
* who convert spontaneously to sinus rhythm prior to randomization; or
* who were previously enrolled in the study.
Safety Exclusions:
1. who are known to have severe heart failure (left ventricular ejection fraction \<30% or have clinical or radiological evidence of acute HF);
2. whose heart rate \< 55 bpm;
3. who have 3rd degree AV block or complete LBBB or a history of 2nd or 3rd degree AV block (in the absence of a permanent pacemaker or implantable cardioverter-defibrillator \[ICD\]);
4. whose ECG shows QTc \>460ms;
5. who have Brugada syndrome (genetic disease with increased risk of sudden cardiac death);
6. who currently take class I or III antiarrhythmic drugs (last dose \< 5 half-lives before enrolment) except Amiodarone;
7. who have hypersensitivity to procainamide, procaine, other ester-type local anesthetics, or any component of the formulation;
8. who have had a recent myocardial infarction (\< 3 months);
9. who have these chronic diseases: renal failure (GFR \<60 mL/min/1.73m2) or liver disease; or
10. who are breast feeding or pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01891058
Study Brief:
Protocol Section:
NCT01891058