Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560047
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure - The DanAblate-HF Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
DanAblate-HF
Brief Summary:
The DanAblate-HF trial will investigate whether early catheter ablation treatment for atrial fibrillation in patients with heart failure is superior to standard treatment
Detailed Description:
Atrial fibrillation AF is the most common arrhythmia in patients with heart failure HF with rates ranging between 20-65 depending on age severity of HF subtypes of HF and duration of HF The two conditions have an intricate and often overlapping pathophysiology with each condition leading to development of the other as well as progression of disease Studies have shown that the presence of AF in HF patients is associated with increased morbidity and mortality deterioration in HF exacerbated HF symptoms and reduced quality of life The optimal treatment of AF in the presence of HF remains unknown Currently there is a pull towards catheter ablation as first-line therapy for AF in HF patients However there is no solid scientific evidence to support this approach Furthermore it is unknown whether early rhythm control by catheter ablation in HF patients is beneficial
The investigators aim to conduct a pragmatic randomized clinical trial designed to evaluate the efficacy and safety of early catheter ablation for AF in patients with HF compared with standard treatment
Eligible patients with HF and AF will be prospectively screened from all Danish hospitals and randomized 11 to early catheter ablation with pulmonary vein isolation within 6 weeks or standard guideline directed treatment for AF Patients with reversible causes for AF conditions that preclude the use of catheter ablation or previous catheter ablation for AF will be excluded from the study Randomization and follow-up will be conducted at six specialized sites in Denmark There will be one scheduled on-site 12-months follow-up visit after randomization All clinical follow-up will be conducted at the patients local hospital according to standard practice and out of trial setting Information regarding hospital visitsadmissions events adverse events changes in medication cross-over heart rhythm and rate and results of relevant blood-work will be ascertained through systematic patient chart-review at pre-specified time-points The results from this trial will mold future treatment of AF in HF patients The investigators hypothesize that early catheter ablation reduces the risk of HF hospitalizations and mortality when compared with standard treatment thereby significantly improving the clinical prognosis for patients with HF and AF
The investigators aim to conduct a pragmatic randomized clinical trial designed to evaluate the efficacy and safety of early catheter ablation for AF in patients with HF compared with standard treatment
Eligible patients with HF and AF will be prospectively screened from all Danish hospitals and randomized 11 to early catheter ablation with pulmonary vein isolation within 6 weeks or standard guideline directed treatment for AF Patients with reversible causes for AF conditions that preclude the use of catheter ablation or previous catheter ablation for AF will be excluded from the study Randomization and follow-up will be conducted at six specialized sites in Denmark There will be one scheduled on-site 12-months follow-up visit after randomization All clinical follow-up will be conducted at the patients local hospital according to standard practice and out of trial setting Information regarding hospital visitsadmissions events adverse events changes in medication cross-over heart rhythm and rate and results of relevant blood-work will be ascertained through systematic patient chart-review at pre-specified time-points The results from this trial will mold future treatment of AF in HF patients The investigators hypothesize that early catheter ablation reduces the risk of HF hospitalizations and mortality when compared with standard treatment thereby significantly improving the clinical prognosis for patients with HF and AF
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