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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00926783




Registration number
NCT00926783
Ethics application status
Date submitted
22/06/2009
Date registered
23/06/2009
Date last updated
5/06/2014

Titles & IDs
Public title
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
Scientific title
Selective CFAE Targeting for Atrial Fibrillation (SELECT-AF)
Secondary ID [1] 0 0
SELECT-AF
Universal Trial Number (UTN)
Trial acronym
SELECT-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - CFAE ablation
Treatment: Surgery - CFAE ablation

Active Comparator: (1) targeted CFAE ablation -

Active Comparator: (2) generalized CFAE ablation -

Active Comparator: (1) targeted CFAE ablation -

Active Comparator: (2) generalized CFAE ablation -


Treatment: Surgery: CFAE ablation
CFAE ablation (targeted vs. generalized)

Treatment: Surgery: CFAE ablation
CFAE ablation (targeted vs. generalized)

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From day 91 to day 365 post first ablation procedure
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
From day 91 to day 365 post first ablation procedure
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
Secondary outcome [1] 0 0
Duration of Ablation Procedure - 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.
Timepoint [1] 0 0
Duration of ablation procedure (up to about 5 hours)
Secondary outcome [2] 0 0
Fluoroscopy Time - 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.
Timepoint [2] 0 0
Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
Secondary outcome [3] 0 0
Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target - Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target
Timepoint [3] 0 0
Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)
Secondary outcome [4] 0 0
Incidence of Atrial Fibrillation (AF) Termination/Regularization - Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure.
Timepoint [4] 0 0
Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
Secondary outcome [5] 0 0
Duration of Ablation Procedure - 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.
Timepoint [5] 0 0
Duration of ablation procedure (up to about 5 hours)
Secondary outcome [6] 0 0
Fluoroscopy Time - 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.
Timepoint [6] 0 0
Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
Secondary outcome [7] 0 0
Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target - Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target
Timepoint [7] 0 0
Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)
Secondary outcome [8] 0 0
Incidence of Atrial Fibrillation (AF) Termination/Regularization - Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure.
Timepoint [8] 0 0
Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biosense Webster, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00926783
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris Hendricks
Address 0 0
Biosense Webster, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications