An MRI-validated study of the superiority of a contact feedback catheter in AF ablation - pre study

An MRI-validated study of the superiority of a contact feedback catheter in AF ablation - pre study - MERCI-AF pre study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40242

Enrollment

Registered

2014-02-03

Start date

2014-04-10

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Atrial Fibrillation

Interventions

Isolation of left or right sided (1:1 randomization) pulmonary veins with feedback on, the controlateral side is isolated using the same catheter but with feedback off.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Paroxysmal atrial fibrillation for which >= 1 electrical and/or chemical cardioversions and persistent atrial fibrillation, eligible for pulmonary vein isolation according to current international guidelines. • Age

Exclusion criteria

Exclusion criteria: • Age

Design outcomes

Primary

Measure	Time frame
To perform a pre-study to assess the feasibility of DE-MRI to assess lesion size, transmurality and completeness of pulmonary vein isolation. The study will be performed to determine if and how DE-MRI can be used in a subsequent multicentre study (MERCI-AF study).	—

Secondary

Measure	Time frame
To collect data on the use of contact-feedback which could be included in the MERCI-AF study.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)