NCT00678340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

5.5 years

First QC Date

February 14, 2008

Last Update Submit

March 5, 2013

Conditions

Atrial Fibrillation

Keywords

Randomized Controlled TrialSingle-Blind StudyCatheter Ablation

Outcome Measures

Primary Outcomes (2)

  • Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording

    1 year

  • Procedural time for pulmonary vein isolation

    Index procedure

Secondary Outcomes (3)

  • All procedural complications

    Index

  • Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure

    6 months

  • Quality of life questionnaire

    6 months and 1 year

Study Arms (2)

1

ACTIVE COMPARATOR

WACA and PVI

Device: WACA and PVI

2

ACTIVE COMPARATOR

PVAC

Device: PVAC

Interventions

WACA and PVIDEVICE

Wide area circumferential ablation (WACA) in the pulmonary vein antrum with subsequent pulmonary vein isolation (PVI) with a single tip irrigated catheter.

1
PVACDEVICE

Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.

Also known as: Pulmonary vein ablation catheter, Ablation Frontiers
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with paroxysmal AF with a planned ablation procedure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Hospital London NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24843051DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pier D Lambiase, PhD

    University College Hospital London NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

February 14, 2008

First Posted

May 15, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

GB(1)