The PVAI+ trial

PVAI alone vs. PVAI plus ablation of CFAE's in a specific area of the left atrium in patients suffering from (longstanding) persistent atrial fibrillation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26057

Enrollment

Registered

2014-03-20

Start date

2014-06-01

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, atrium fibrilleren Catheter ablation, katheter ablatie Fractionation, fractionatie CFAE Pulmonary vein antrum isolation, pulmonaal vene antrum isolatie

Interventions

- The standard care group: pulmonary vein antrum isolation alone - The PVAI+ group: pulmonary vein antrum isolation plus limited ablation of CFAE’s in a specific region of the left atrium (under the r

Eligibility

Inclusion criteria

Inclusion criteria: - Patients age is > 18 years - Patients with persistent or longstanding persistent atrial fibrillation. Persistent AF is defined as sustained episodes of atrial fibrillation lasting >7 days. Longstanding persistent AF is defined as sustained episode lasting >1 year - Patients undergoing a first time ablation procedure for persistent atrial fibrillation - AF must be recorded at least once by ECG, holter, telemetry, loop recorder or internal device. - Patients must give informed consent to participate

Exclusion criteria

Exclusion criteria: - Patients suffering from paroxysmal atrial fibrillation. Paroxysmal AF is defined as episodes of AF that terminates spontaneously within 7 days. - Patients with any exclusion criteria or contra-indications for electrophysiologic study and ablation in the left atrium, such as pregnancy or presence of a left atrial thrombus - Prior PVAI with RF or Cryo ablation - Not capable of giving informed consent

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to evaluate which ablation strategy- PVAI alone or PVAI plus limited ablation of CFAE’s in a specific region of the left atrium- is most effective in treating persistent and longstanding persistent atrial fibrillation measured by success at 12 months after 1 or 2 procedures.	—

Secondary

Measure	Time frame
-procedural duration -fluoroscopy time -number of repeat procedures -number of patients showing CFAE in the particular region of the left atrium -incidence of periprocedural complications -quality of life measurements before and after ablation	—

Contacts

Public ContactC. Teunissen

Heidelberglaan 100

c.teunissen-2@umcutrecht.nl+3188-7550398

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)