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
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
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
NCT ID
NCT00678340
First Posted
February 14, 2008
Last Updated
March 5, 2013
Sponsor
Pier Lambiase
Collaborators
University Hospital Southampton NHS Foundation Trust, The Royal Bournemouth Hospital
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
Learn more about this trial
Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation
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