CompletedPhase 3

APAF: Assessment of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation

Italy458 participantsStarted 2005-05

Plain-language summary

A suboptimal level of resynchronization (cardiac resynchronization therapy \[CRT\]) achieved in many patients with actual standards and techniques based on tissue-Doppler echocardiography could be more effective to obtain better CRT results. Eligible patients who successfully received atrioventricular (AV) junction ablation and biventricular (BiV) pacing are randomised to a comparison between a strategy of right ventricular (RV) apical pacing with delayed CRT based on clinical indications with a strategy of early optimal CRT based on an echocardiographic stratification. End-points: * Acute echo comparison (acute echo study) * Quality of life and exercise tolerance (Short-term clinical study) * Composite end-point of CRT clinical failure (Long-term clinical study)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with permanent AF in whom a clinical decision had been made to undertake complete AV junction ablation and ventricular pacing because of drug-refractory, severely symptomatic, uncontrolled high ventricular rate * Patients with permanent AF, drug-refractory heart failure, depressed LV function in whom a clinical decision had been made to undertake left ventricular synchronization pacing Exclusion Criteria: * New York Heart Association class IV heart failure, or systolic blood pressure ≥80 mmHg * Severe concomitant non cardiac disease * Need for surgical intervention * Myocardial infarction within 3 months * Primary hypertrophic cardiomyopathy * Arrhythmogenic right ventricular dysplasia * Primary valvular heart disease * Sustained ventricular tachycardia or ventricular fibrillation * Previously implanted pacemaker * Inability to obtain reliable RV and LV pacing and persistent AV block

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Short-term clinical study (6 months): Quality of life (measured as Minnesota Living with Heart Failure Questionnaire, Specific Symptom Scale and New York Heart Association classification) and exercise capacity at 6 months in the 2 study groups

Timeframe: 6 months

Long-term clinical study (24 months): Composite end-point of: death due to cardiovascular cause, hospitalisation for worsening heart failure, worsening heart failure or failure to achieve a persistent subjective symptom improvement (clinical failure)

Timeframe: 24 months

Trial details

NCT IDNCT00111527

SponsorAzienda USL Reggio Emilia - IRCCS

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2009-08

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