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

NCT ID: NCT04784013

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-24
• Study Completion Date: 2022-05-31

Brief 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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional group

Group Type: ACTIVE_COMPARATOR

Conventional CLOSE-guided pulmonary vein isolation

Intervention Type: PROCEDURE

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.

90W-group

Group Type: ACTIVE_COMPARATOR

High power short duration pulmonary vein isolation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Jan AV

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Mattias Duytschaever

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mattias Duytschaever, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Jan AV

Locations

Medical University Hospital Graz

Graz, , Austria

AZ Sint-Jan Brugge-Oostende AV

Bruges, Please Select, Belgium

UMC Leiden

Leiden, , Netherlands

Luzerner Kantonsspital

Lucerne, , Switzerland

Countries

Austria; Belgium; Netherlands; Switzerland

References

O'Neill L, El Haddad M, Berte B, Kobza R, Hilfiker G, Scherr D, Manninger M, Wijnmaalen AP, Trines SA, Wielandts JY, Gillis K, Lycke M, De Becker B, Tavernier R, Le Polain De Waroux JB, Knecht S, Duytschaever M. Very High-Power Ablation for Contiguous Pulmonary Vein Isolation: Results From the Randomized POWER PLUS Trial. JACC Clin Electrophysiol. 2023 Apr;9(4):511-522. doi: 10.1016/j.jacep.2022.10.039. Epub 2023 Jan 18.

Reference Type: DERIVED

PMID: 36752467 (View on PubMed)

Other Identifiers

2800

Identifier Type: -

Identifier Source: org_study_id