PVAI alone vs. PVAI plus ablation of complex fractionated atrial electrograms in a specific area of the left atrium in patients suffering from (longstanding) persistent atrial fibrillation.

PVAI alone vs. PVAI plus ablation of complex fractionated atrial electrograms in a specific area of the left atrium in patients suffering from (longstanding) persistent atrial fibrillation. - The PVAI+ trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41115

Enrollment

Registered

2014-07-09

Start date

2014-09-09

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

pulmonary vein antrum isolation plus limited ablation of CFAE*s in a specific region of the left atrium (the area under the right inferior pulmonary vein, the inferior left atrial septum and the ost

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients age is >= 18 years - Patients with persistent or longstanding persistent atrial fibrillation. - 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. - 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 cry ablation

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 CFAEs 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. Success is defined as freedom from recurrences following the 3-month blanking period in the absence of Class I and III AAD therapy. Recurrence is defined as recurrence of atrial fibrillation, atrial flutter or atrial tachycardia of at least 30 seconds duration that is documented by an ECG or device recording system more than 3 months following AF-ablation.	—

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. Success is defined as freedom from recurrences following the 3-month blanking period in the absence of Class I and III AAD therapy. Recurrence is defined as recurrence of atrial fibrillation, atrial flutter or atrial tachycardia of at least 30 seconds* duration that is documented by an ECG or device recording system more than 3 months following AF-ablation.

—

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	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)