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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT00225667
Eligibility Criteria:
Inclusion Criteria:
* Sinus Node Dysfunction (with or without AV conduction disturbance)
* Permanent, atrial or dual-chamber pacemaker implanted \> 2 months before enrollment and with ability to record and store atrial high-rate episodes, frequency of mode switches and to perform non-invasive electrophysiologic testing
* History of at least 6 AHRE in the last 6 months (rate \> 220/min, duration of \> 2 minutes
* History of prior diagnosis of hypertension and/or treated for hypertension OR two documented BP \> 130/85 (measurements done at least one week apart)
Exclusion Criteria:
* Permanent or persistent AF or more than 6 episodes of symptomatic paroxysmal AF in the previous 6 months
* Documented Cr \>200 umol/L and K+ \>5.2 mmol/L in the previous 3 months
* Current treatment with a potassium sparing diuretic, unless serum potassium known to be in the normal range
* LV ejection fraction known to be \< 40 %
* Moderate or severe mitral regurgitation (3+, 4 +)
* Mitral stenosis of more than mild severity
* Aortic stenosis with mean gradient of \> 25 mmHg
* Angina at rest in the last 2 months, or current CCS Class 3 or 4 angina
* Unipolar atrial lead
* Previous AV node ablation
* P-wave amplitude less than 1.5 mV
* Current therapy with an ACE inhibitor, ARB or aldosterone antagonist
* Current or planned (within 6 months) with an anti-arrhythmic medication (amiodarone, sotalol, flecainide, propafenone, quinidine, dofetilide
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00225667
Study Brief:
Protocol Section:
NCT00225667