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Efficacy of DE-MRI-Guided Ablation vs. Conventional Catheter Ablation of Atrial Fibrillation

Efficacy of DE-MRI-Guided Ablation vs. Conventional Catheter Ablation of Atrial Fibrillation - DECAAF II

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53352
Enrollment
80
Registered
2019-10-23
Start date
2016-12-04
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation palpitations

Interventions

After verifying adequate quality of the DE-MRI study, subjects will be randomized to one of two study groups to receive conventional PVI ablation (Group 1) or PVI + fibrosis-guided ablation (Group 2
ablation
atrial fibrillation
cardiac arrhythmias

Sponsors

University of Utah health Sciences Center
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patients with persistent AF undergoing first AF ablation as per recent HRS consensus document. Persistent AF is defined by 7 days or more in AF as evidenced by either 1) rhythm strip or 2) written documentation. - Must have some proportion of atrial fibrosis (not limited to advanced stage fibrosis). - Able to understand and willing to sign the Informed Consent Form. - Age * 18 years.

Exclusion criteria

Exclusion criteria: - Contraindication for DE-MRI with a full dose of Gadolinium-based contrast agent. - Previous left atrial ablation or surgical procedure. - Women currently pregnant. - Mental or physical inability to take part in the study. - Uncontrolled hypertension. - Inability to be placed in MRI due to body mass.

Design outcomes

Primary

MeasureTime frame
To examine the efficacy of targeting atrial fibrosis tissue during an ablation procedure in treating persistent AF. The frequencies and proportions of patients experiencing each of three components of the primary AA outcome: atrial fibrillation atrial flutter atrial tachycardia

Secondary

MeasureTime frame
Quality of life as measured by the Toronto Score. A composite outcome including AA recurrence and prescription of an anti-arrhythmic medication, stroke, cardiovascular hospitalization, a repeat ablation, AA recurrence following repeat ablation

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)