Hybrid Ablation of Atrial Fibrillation in Heart Failure (NCT05411614) | Clinical Trial Compass
RecruitingNot Applicable
Hybrid Ablation of Atrial Fibrillation in Heart Failure
United Kingdom120 participantsStarted 2022-06-25
Plain-language summary
A randomised controlled trial to assess the efficacy of staged hybrid ablation when compared with standard catheter ablation in patients with non-paroxysmal atrial fibrillation (AF) and Heart Failure
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Persistent or Long-standing Persistent AF
* Dilated left atrium (at least moderately dilated)
* Suitable for either procedure
* LVEF \< 50%
Exclusion Criteria:
* Not yet optimised from a medical or lifestyle perspective for AF or heart failure
* Unable to provide written consent
* Previous open-heart surgery
* Active infection, oesophageal ulcer stricture or oesophageal varices
* Prior catheter ablation of atrial fibrillation (prior ablation for atrial flutter / supraventricular tachycardia or ventricular arrhythmia acceptable)
* Contraindication to anticoagulation, or active thrombus in the left atrium despite therapeutic anticoagulation
* Severe valvular heart disease
* Unstable coronary artery disease
* Uncontrolled ventricular arrhythmia
* Heart attack or stroke within the last 90 days
* Pregnant, breastfeeding, or women of childbearing age who plan to get pregnant within six months
* Severe concomitant condition or presence of an implanted device that would preclude the patient from undergoing trial procedures
What they're measuring
1
Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications
Timeframe: Measured from the end of a 3-month blanking period at 12 and 24 months