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CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications (POWERAF)

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

High power CLOSE-guided PVI ablation

Standard CLOSE-guided PVI ablation

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients referred for symptomatic paroxysmal AF and without advanced structural heart disease
Signed Patient Informed Consent Form
Age 18 years or older
Able and willing to comply with all follow-up testing and requirements

Exclusion Criteria:

Persistent atrial fibrillation (history of AF>7days or history of cardioversion > 48h of AF)
Previous ablation for AF
LA antero-posterior diameter>50 mm (parasternal long axis view , PLAX)
LVEF <35% (ejection fraction)
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
CABG procedure within the last three months
Awaiting cardiac transplantation or other cardiac surgery
Documented left atrial thrombus on imaging
Diagnosed atrial myxoma
Women who are pregnant or breastfeeding
Acute illness or active systemic infection or sepsis
Unstable angina
Uncontrolled heart failure
Myocardial infarction within the previous two months
History of blood clotting or bleeding abnormalities
Contraindication to anticoagulation therapy (ie, heparin or warfarin)
Life expectancy less than 12 months
Enrollment in any other study evaluating another device or drug
Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction

Sites / Locations

Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

High power group

Standard group

Arm Description

The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds).

The control group will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds)

Outcomes

Primary Outcome Measures

Efficacy: Acute procedural success

First pass pulmonary vein isolation confirmed after adenosine injection

Safety: Absence of clinical complications

Absence of clinical complications during the procedure and up to one month thereafter

Secondary Outcome Measures

Procedural duration time

Duration for pulmonary vein isolation

Fluoroscopic duration and irradiation (AK)

Amount of ablation points associated with temperature rise

Maximum temperature in case of temperature rise

Incidence of adverse events related to ablation

First pass encirclement isolation rate

Reconnection rate after adenosine

Number of dislocations

Number of ablation points with an oesophageal temperature rise >39°C

Maximum temperature in case of oesophageal temperature rise

Longterm procedural success rate

Full Information

NCT ID

NCT04122963

First Posted

October 9, 2019

Last Updated

February 10, 2021

Sponsor

AZ Sint-Jan AV

1. Study Identification

Unique Protocol Identification Number

NCT04122963

Brief Title

CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications

Acronym

POWERAF

Official Title

CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications: a Randomized Study. The POWERAF Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

February 15, 2019 (Actual)

Primary Completion Date

September 25, 2019 (Actual)

Study Completion Date

June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

AZ Sint-Jan AV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

In this prospective, randomised, controlled, unblinded,monocentric study, we aim to evaluate the safety and efficacy of higher power CLOSE-guided PVI in patients referred for a first ablation for paroxysmal AF. We aim to include 100 patients into two groups (1:1). The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds) compared to the control group which will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds).

Detailed Description

BACKGROUND: In a population of paroxysmal AF 'CLOSE'-guided PVI (Target Ablation index (AI) >550 and >400 for anterior and posterior wall respectively, interlesion distance ≤6mm) has been shown to obtain single-procedure durable PV isolation. However, the optimal RF power and stability criteria is unknown. OBJECTIVES: With this study, we aim at evaluation the efficacy and the safety of higher power (45 watts) and stricter stability criteria (3 mm for 3 sec) as compared to a standard CLOSE protocol (35 watts with stability of 3 mm for 8 sec) in patients referred for a first ablation for paroxysmal AF. POPULATION: Eligible patients are patients with paroxysmal AF who are planned for a 'CLOSE'-guided PV isolation for paroxysmal AF. At the time of the procedrual planning, we will ask the patient his/her consent for collectio of data. We aim at including 100 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High power group

Arm Type

Active Comparator

Arm Description

The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds).

Arm Title

Standard group

Arm Type

Active Comparator

Arm Description

The control group will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds)

Intervention Type

Procedure

Intervention Name(s)

High power CLOSE-guided PVI ablation

Intervention Description

CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)

Intervention Type

Procedure

Intervention Name(s)

Standard CLOSE-guided PVI ablation

Intervention Description

Standard AF ablation according to the CLOSE-protocol

Primary Outcome Measure Information:

Title

Efficacy: Acute procedural success

Description

First pass pulmonary vein isolation confirmed after adenosine injection

Time Frame

At time of ablation

Title

Safety: Absence of clinical complications

Description

Absence of clinical complications during the procedure and up to one month thereafter

Time Frame

From time of ablation to 1 month post procedure

Secondary Outcome Measure Information:

Title

Procedural duration time

Time Frame

At time of ablation

Title

Duration for pulmonary vein isolation

Time Frame

At time of ablation

Title

Fluoroscopic duration and irradiation (AK)

Time Frame

At time of ablation

Title

Amount of ablation points associated with temperature rise

Time Frame

At time of ablation

Title

Maximum temperature in case of temperature rise

Time Frame

At time of ablation

Title

Incidence of adverse events related to ablation

Time Frame

From time of ablation to 6 months post procedure

Title

First pass encirclement isolation rate

Time Frame

At time of ablation

Title

Reconnection rate after adenosine

Time Frame

At time of ablation

Title

Number of dislocations

Time Frame

At time of ablation

Title

Number of ablation points with an oesophageal temperature rise >39°C

Time Frame

At time of ablation

Title

Maximum temperature in case of oesophageal temperature rise

Time Frame

At time of ablation

Title

Longterm procedural success rate

Time Frame

Six months after ablation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients referred for symptomatic paroxysmal AF and without advanced structural heart disease Signed Patient Informed Consent Form Age 18 years or older Able and willing to comply with all follow-up testing and requirements Exclusion Criteria: Persistent atrial fibrillation (history of AF>7days or history of cardioversion > 48h of AF) Previous ablation for AF LA antero-posterior diameter>50 mm (parasternal long axis view , PLAX) LVEF <35% (ejection fraction) AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause CABG procedure within the last three months Awaiting cardiac transplantation or other cardiac surgery Documented left atrial thrombus on imaging Diagnosed atrial myxoma Women who are pregnant or breastfeeding Acute illness or active systemic infection or sepsis Unstable angina Uncontrolled heart failure Myocardial infarction within the previous two months History of blood clotting or bleeding abnormalities Contraindication to anticoagulation therapy (ie, heparin or warfarin) Life expectancy less than 12 months Enrollment in any other study evaluating another device or drug Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction

Facility Information:

Facility Name

Department of Cardiology

City

Bruges

ZIP/Postal Code

8000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33300809

Citation

Wielandts JY, Kyriakopoulou M, Almorad A, Hilfiker G, Strisciuglio T, Phlips T, El Haddad M, Lycke M, Unger P, Le Polain de Waroux JB, Vandekerckhove Y, Tavernier R, Duytschaever M, Knecht S. Prospective Randomized Evaluation of High Power During CLOSE-Guided Pulmonary Vein Isolation: The POWER-AF Study. Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e009112. doi: 10.1161/CIRCEP.120.009112. Epub 2020 Dec 10.

Results Reference

result

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CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications

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