Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation

Atrial Fibrillation Clinical Trial

— POWER-PLUS  

Official title:

Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation: the POWER-PLUS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04784013
• Other study ID #: 2800
• Status: Completed
• Phase: Phase 4
• Start date: March 24, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: May 31, 2022
• Est. primary completion date: October 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years

• Patients scheduled for a first PVI only for paroxysmal atrial fibrillation (AF) (self-terminating or <7days) or persistent AF (persistent AF is defined as having an AF episode >7d); (patients with paroxysmal AF or short-standing persistent AF presenting with flutter, who are in need of a cavotricuspid isthmus ablation, are allowed to participate in this trial)

• Patients willing to sign informed consent

Exclusion Criteria:

• Patients with long-standing persistent AF (long-standing persistent AF is defined as having an AF episode >1yr)

• Previous ablation for AF

• Left atrium antero-posterior diameter >50 mm (parasternal long axis view, PLAX)

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause

• Left atrial appendage (LAA) thrombus. LAA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.

• Left ventricular ejection fraction <35%.

• Cardiac surgery within the previous 90 days.

• Expecting cardiac transplantation or other cardiac surgery within 180 days.

• Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days.

• Documented history of a thromboembolic event within the previous 90 days.

• Diagnosed atrial myxoma.

• Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.

• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment

• Women who are pregnant or who plan to become pregnant during the study.

• Acute illness or active infection at time of index procedure

• Advanced renal insufficiency

• Unstable angina.

• History of blood clotting or bleeding abnormalities.

• Contraindication to anticoagulation.

• Life expectancy less than 1 year.

• Presence of a condition that precludes vascular access.

• Unwilling or unable to provide informed consent.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Conventional CLOSE-guided pulmonary vein isolation
Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in a temperature and flow-controlled mode (QMODE, target temperature 45°C, low flow temperature 40°C, cut-off temperature 50°C) with a power of 35W(posterior)/50W(anterior) (irrigation flow at 4-15ml/min). RF will be delivered until an ablation index (AI) of =400 at the posterior wall/roof/south pole and =550 at the anterior wall.
• High power short duration pulmonary vein isolation
Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in temperature-controlled mode (QMode+, target temperature 55°C, cut-off temperature 65°C) with a power of 90W (irrigation flow at 2-8ml/min). RF will be delivered for 4 sec at both the posterior and anterior wall.

Locations

Country	Name	City	State
Austria	Medical University Hospital Graz	Graz
Belgium	AZ Sint-Jan Brugge-Oostende AV	Brugge	Please Select
Netherlands	UMC Leiden	Leiden
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Countries where clinical trial is conducted

Austria,  Belgium,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural time	Comparison of the procedural time (in minutes) between groups	Procedure (At time of ablation)
Secondary	Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation	Atrial tachyarrhythmia will be monitored by Holter	Months 4-6 after ablation
Secondary	Radiofrequency (RF) ablation time	Comparison of the RF ablation time (in seconds) between groups	Procedure (At time of ablation)
Secondary	Fluoroscopy dose	Comparison of the fluoroscopy dose (Gy cm²) between groups	Procedure (At time of ablation)
Secondary	First pass isolation rate	Reconnection of the veins after adenosine injection or waiting time	Procedure (At time of ablation)