Ignite Creation Date:
2024-10-25 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505798
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
CryoballoonRadiofrequency Ablation of Atrial Fibrillation Versus Medical Treatment for Heart
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CryoballoonRadiofrequency Ablation of Atrial Fibrillation Versus Medical Treatment for Heart
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRAAFT-HF
Brief Summary:
Atrial fibrillation AF is a common heart rhythm disorder that causes an irregular heart beat and is a cause of heart failure HF Treatments include drugs to slow the heart rate anti-arrhythmic drugs or ablation of the heart to help preserve normal rhythm A number of trials have suggested that ablation may be superior to drug treatment to reduce hospitalisations or prevent early death However these studies have been small and the results not applicable to the general population with AF and heart failure in the UK This international study will compare catheter ablation and optimal medical therapy versus optimal medical therapy alone to see if catheter ablation reduces unplanned heart failure hospitalisations and death rates and improves quality of life
Detailed Description:
Atrial fibrillation AF increases the severity of and death from heart failure HF Several small studies have demonstrated that restoration of sinus rhythm by catheter ablation in patients with HF improves left ventricular LV function and exercise tolerance What is unknown is whether or not AF ablation reduces all-cause death and urgent CV hospitalisations in populations with HF The current trial will answer this outstanding question which is faced by HF clinicians and electrophysiologists on a daily basis AF ablation can be performed very effectively and efficiently using a cryo-balloon or radio-frequency ablation PVI technique These techniques have evolved slowly and are unlikely to change substantially over the course of this trial One small trial n363 in implantable cardioverter-defibrillator and CRT defibrillator recipients CASTLE-AF reported a death benefit of AF ablation but the patients were highly selected and the death reduction was far higher than real world expected differences Recent studies have noted that the population randomised in CASTLE-AF was not representative of the general HF population with only 7 of patients in the real world setting meeting the trial entry criteria CASTLE-AF is therefore provocative but inconclusive it has made little change to clinical practice As no studies have investigated the death benefit in a general HF population the proposed trial is necessary and warranted This study is designed as a randomised open label multicentre clinical trial in which catheter ablation and medical therapy is compared to medical therapy alone in patients with HF with reduced ejection fraction 50 and paroxysmal or persistent AF to determine if this reduces all-cause death and urgent CV hospitalisations as well as improving QoL By utilising the clinical and research networks of the British Heart Failure Society and British Heart Rhythm Society BHRS we will recruit 1200 patients The current trial will be almost three times the size of the only previous inconclusive trial which was reported in the New England Journal of Medicine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None