NCT00926783

Brief Summary

This study will be a multicenter, open, prospective, randomized trial. Patients with either paroxysmal or persistent atrial fibrillation will be considered for the study. (For US, only paroxysmal atrial fibrillation will be considered.) Eligible subjects will be randomized into one of two arms in the study: (1) targeted CFAE ablation or (2) generalized CFAE ablation. Both techniques will then be followed by PVAI (pulmonary vein antral isolation) as part of a hybrid ablation strategy. The nature of the ablation procedures does not allow physicians to be blinded to the randomization.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Aug 2009

Typical duration for phase_4 atrial-fibrillation

Geographic Reach
3 countries

7 active sites

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

First Submitted

Initial submission to the registry

June 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

June 3, 2014

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

2.3 years

First QC Date

June 22, 2009

Results QC Date

March 24, 2014

Last Update Submit

June 5, 2014

Conditions

Atrial Fibrillation

Keywords

paroxysmalpersistenttargetedgeneralizedCFAE

Outcome Measures

Primary Outcomes (2)

  • Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.

    Proportion of subjects who were free from atrial arrhythmia (no recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT)) between Day 91 and Day 365 post first ablation procedure.

    From day 91 to day 365 post first ablation procedure

  • Total Radio-frequency (RF) Delivery Time During CFAE

    Total RF delivery time (minutes) is defined as the duration of the RF delivered per ablation site and totaled for each procedure.

    Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)

Secondary Outcomes (4)

  • Duration of Ablation Procedure

    Duration of ablation procedure (up to about 5 hours)

  • Fluoroscopy Time

    Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)

  • Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target

    Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)

  • Incidence of Atrial Fibrillation (AF) Termination/Regularization

    Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)

Study Arms (2)

(1) targeted CFAE ablation

ACTIVE COMPARATOR
Procedure: CFAE ablation

(2) generalized CFAE ablation

ACTIVE COMPARATOR
Procedure: CFAE ablation

Interventions

CFAE ablationPROCEDURE

CFAE ablation (targeted vs. generalized)

Also known as: CFAE ablation (targeted vs. generalized), NaviStar ThermoCool Catheter, CARTO mapping system
(1) targeted CFAE ablation(2) generalized CFAE ablation

Eligibility Criteria

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

You may qualify if:

  • Candidates for this study must meet ALL of the following criteria:
  • Age ≥ 18 years old
  • First-time ablation procedure for AF
  • Symptomatic AF which has been refractory to at least one antiarrhythmic medication (AAD). "Symptomatic" patients are those who have been aware of their AF anytime within the last 5 years. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, or other symptoms, or any combination of the above
  • One of the following must apply:
  • AF must either be PERSISTENT AF (non-US sites only) or HIGH BURDEN PAROXYSMAL AF - High burden paroxysmal AF is defined as episodes that terminate within 30 days and meet any ONE of the following criteria:
  • More than 1 episode of AF per month in the preceding 6 months with at least 1 episode lasting \>24 hours by symptoms,
  • LA size of \>/= 48 mm in the PLAX (parasternal long axis) view on echocardiography
  • LA volume \>/= 100 cc
  • Total AF history \>/= 10 years
  • Patients must be able and willing to provide written informed consent to participate in the study.
  • Able and willing to comply with all pre-, post- and follow-up testing and requirements.

You may not qualify if:

  • Candidates will be excluded from the study if any of the following conditions apply:
  • Patients with long-standing persistent AF \>1 year for which cardioversion (pharmacologic or electrical) has failed or will never be attempted.
  • Patients with AF felt to be secondary to an obvious reversible cause.
  • Patients with contraindications to systemic anticoagulation with heparin or Coumadin.
  • Patients who have previously undergone atrial fibrillation ablation.
  • Patients who are pregnant (by history of menses or pregnancy test if history is considered unreliable.
  • Left atrial size ≥55 mm (PLAX view on echocardiography).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Location

Southlake Regional Health Center

Newmarket, Ontario, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

Hopital Laval - Institut universitaire de cardiologie et de pneumonologie

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

  • Verma A, Sanders P, Champagne J, Macle L, Nair GM, Calkins H, Wilber DJ. Selective complex fractionated atrial electrograms targeting for atrial fibrillation study (SELECT AF): a multicenter, randomized trial. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):55-62. doi: 10.1161/CIRCEP.113.000890. Epub 2014 Jan 14.

    PMID: 24425420DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ellen Harris, Sr. Clinical Research Associate, Clinical Operations
Organization
Biosense Webster EMEA
eharris@its.jnj.com
(800) 729-9010

Study Officials

  • Chris Hendricks

    Biosense Webster, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 24, 2009

Study Start

August 1, 2009

Primary Completion

November 1, 2011

Study Completion

September 1, 2013

Last Updated

June 10, 2014

Results First Posted

June 3, 2014

Record last verified: 2014-06

Locations

US(2)CA(4)AU(1)