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Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
WACA and PVI
PVAC
Sponsored by
Pier Lambiase
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Randomized Controlled Trial, Single-Blind Study, Catheter Ablation

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with paroxysmal AF with a planned ablation procedure

Exclusion Criteria:

  • Prior AF ablation
  • LA size greater than 60mm
  • Mechanical prosthetic MVR
  • Hypertrophic cardiomyopathy

Sites / Locations

  • University College Hospital London NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

WACA and PVI

PVAC

Outcomes

Primary Outcome Measures

Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording
Procedural time for pulmonary vein isolation

Secondary Outcome Measures

All procedural complications
Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure
Quality of life questionnaire

Full Information

First Posted
February 14, 2008
Last Updated
March 5, 2013
Sponsor
Pier Lambiase
Collaborators
University Hospital Southampton NHS Foundation Trust, The Royal Bournemouth Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00678340
Brief Title
Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation
Official Title
A Single Centre, Randomized, Single Blinded Trial of Wide Area Circumferential Ablation With Pulmonary Vein Isolation Compared to a Multipolar, Circular Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pier Lambiase
Collaborators
University Hospital Southampton NHS Foundation Trust, The Royal Bournemouth Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Atrial fibrillation (AF) is a chaotic heart rhythm of the top chambers of the heart. AF occurs in up to 10% of the population over the age of 60. It is associated with tiredness, impaired functional capacity and is the cause of up to 10% of strokes. Ablation is a procedure performed with small tubes (catheters) that are introduced through the top of the leg. Burns are made inside of the heart to treat AF. This procedure has been shown to cure 90% of patients with intermittent (paroxysmal) AF. The investigators currently use either one of two different catheters to create these burns inside the heart. The investigators do not know which is the best catheter to use in patients with paroxysmal atrial fibrillation. The investigators study will randomly allocate patients to have their ablation performed by either one of the catheters to give a fair comparison between the two. The investigators objective is to study the differences between these two catheters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Randomized Controlled Trial, Single-Blind Study, Catheter Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
WACA and PVI
Arm Title
2
Arm Type
Active Comparator
Arm Description
PVAC
Intervention Type
Device
Intervention Name(s)
WACA and PVI
Intervention Description
Wide area circumferential ablation (WACA) in the pulmonary vein antrum with subsequent pulmonary vein isolation (PVI) with a single tip irrigated catheter.
Intervention Type
Device
Intervention Name(s)
PVAC
Other Intervention Name(s)
Pulmonary vein ablation catheter, Ablation Frontiers
Intervention Description
Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.
Primary Outcome Measure Information:
Title
Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording
Time Frame
1 year
Title
Procedural time for pulmonary vein isolation
Time Frame
Index procedure
Secondary Outcome Measure Information:
Title
All procedural complications
Time Frame
Index
Title
Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure
Time Frame
6 months
Title
Quality of life questionnaire
Time Frame
6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with paroxysmal AF with a planned ablation procedure Exclusion Criteria: Prior AF ablation LA size greater than 60mm Mechanical prosthetic MVR Hypertrophic cardiomyopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pier D Lambiase, PhD
Organizational Affiliation
University College Hospital London NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Hospital London NHS Foundation Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24843051
Citation
McCready J, Chow AW, Lowe MD, Segal OR, Ahsan S, de Bono J, Dhaliwal M, Mfuko C, Ng A, Rowland ER, Bradley RJ, Paisey J, Roberts P, Morgan JM, Sandilands A, Yue A, Lambiase PD. Safety and efficacy of multipolar pulmonary vein ablation catheter vs. irrigated radiofrequency ablation for paroxysmal atrial fibrillation: a randomized multicentre trial. Europace. 2014 Aug;16(8):1145-53. doi: 10.1093/europace/euu064. Epub 2014 May 19.
Results Reference
derived

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Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

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