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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00926783
Registration number
NCT00926783
Ethics application status
Date submitted
22/06/2009
Date registered
24/06/2009
Date last updated
10/06/2014
Titles & IDs
Public title
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
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Scientific title
Selective CFAE Targeting for Atrial Fibrillation (SELECT-AF)
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Secondary ID [1]
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SELECT-AF
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Universal Trial Number (UTN)
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Trial acronym
SELECT-AF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - CFAE ablation
Active comparator: (1) targeted CFAE ablation -
Active comparator: (2) generalized CFAE ablation -
Treatment: Surgery: CFAE ablation
CFAE ablation (targeted vs. generalized)
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.
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Assessment method [1]
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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.
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Timepoint [1]
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From day 91 to day 365 post first ablation procedure
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Primary outcome [2]
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Total Radio-frequency (RF) Delivery Time During CFAE
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Assessment method [2]
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Total RF delivery time (minutes) is defined as the duration of the RF delivered per ablation site and totaled for each procedure.
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Timepoint [2]
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Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
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Secondary outcome [1]
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Duration of Ablation Procedure
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Assessment method [1]
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Duration of ablation procedure includes three components: Access time - Time from first stick to tracking of the NAVISTAR catheter to the chamber of interest; Mapping time - Creation of first workable map; Ablation and verification time - Creation and verification of all ablation points including pulmonary vein isolation and complex fractionated electrograms.
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Timepoint [1]
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Duration of ablation procedure (up to about 5 hours)
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Secondary outcome [2]
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Fluoroscopy Time
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Assessment method [2]
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Fluoroscopy time is divided into: Fluoroscopy time for access - Time to track the NAVISTAR catheter to the chamber of interest; Fluoroscopy time to map - Creation of first workable map, ablation, and verification time; Fluoroscopy to create and verify all ablation points including pulmonary vein isolation and complex fractionated electrograms.
Fluoroscopy time for access is independent of the strategies and will not be included in comparative analysis.
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Timepoint [2]
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Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
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Secondary outcome [3]
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Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target
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Assessment method [3]
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Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target
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Timepoint [3]
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Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)
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Secondary outcome [4]
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Incidence of Atrial Fibrillation (AF) Termination/Regularization
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Assessment method [4]
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Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure.
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Timepoint [4]
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Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
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Eligibility
Key inclusion criteria
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
* At least one episode of AF must have been documented by ECG, Holter, TTM, or telemetry strip within 24 months of inclusion in the study.
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2013
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Sample size
Target
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Accrual to date
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Final
86
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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Country [2]
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United States of America
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State/province [2]
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Maryland
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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Canada
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State/province [4]
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Quebec
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Biosense Webster, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00926783
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Chris Hendricks
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Address
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Biosense Webster, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00926783
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