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Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation (POWER-PLUS)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Conventional CLOSE-guided pulmonary vein isolation
High power short duration pulmonary vein isolation
Sponsored by
AZ Sint-Jan AV
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • 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.

Sites / Locations

  • Medical University Hospital Graz
  • AZ Sint-Jan Brugge-Oostende AV
  • UMC Leiden
  • Luzerner Kantonsspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional group

90W-group

Arm Description

Outcomes

Primary Outcome Measures

Procedural time
Comparison of the procedural time (in minutes) between groups

Secondary Outcome Measures

Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation
Atrial tachyarrhythmia will be monitored by Holter
Radiofrequency (RF) ablation time
Comparison of the RF ablation time (in seconds) between groups
Fluoroscopy dose
Comparison of the fluoroscopy dose (Gy cm²) between groups
First pass isolation rate
Reconnection of the veins after adenosine injection or waiting time

Full Information

First Posted
March 3, 2021
Last Updated
June 17, 2022
Sponsor
AZ Sint-Jan AV
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1. Study Identification

Unique Protocol Identification Number
NCT04784013
Brief Title
Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation
Acronym
POWER-PLUS
Official Title
Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation: the POWER-PLUS Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
October 22, 2021 (Actual)
Study Completion Date
May 31, 2022 (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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional group
Arm Type
Active Comparator
Arm Title
90W-group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Conventional CLOSE-guided pulmonary vein isolation
Intervention Description
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
Intervention Name(s)
High power short duration pulmonary vein isolation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Procedural time
Description
Comparison of the procedural time (in minutes) between groups
Time Frame
Procedure (At time of ablation)
Secondary Outcome Measure Information:
Title
Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation
Description
Atrial tachyarrhythmia will be monitored by Holter
Time Frame
Months 4-6 after ablation
Title
Radiofrequency (RF) ablation time
Description
Comparison of the RF ablation time (in seconds) between groups
Time Frame
Procedure (At time of ablation)
Title
Fluoroscopy dose
Description
Comparison of the fluoroscopy dose (Gy cm²) between groups
Time Frame
Procedure (At time of ablation)
Title
First pass isolation rate
Description
Reconnection of the veins after adenosine injection or waiting time
Time Frame
Procedure (At time of ablation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattias Duytschaever, MD, PhD
Organizational Affiliation
AZ Sint-Jan AV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Hospital Graz
City
Graz
Country
Austria
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
State/Province
Please Select
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UMC Leiden
City
Leiden
Country
Netherlands
Facility Name
Luzerner Kantonsspital
City
Luzern
Country
Switzerland

12. IPD Sharing Statement

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

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