Atrial FibrillationPhase 4SELECT-AFNCT00926783
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
A Phase 4 study testing CFAE ablation in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 7 sites in 3 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- CFAE ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Aug 2009to Sep 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Canada4 sites
Hamilton Health Sciences Centre
Hamilton, Ontario
Montreal Heart Institute
Montreal, Quebec
Southlake Regional Health Center
Newmarket, Ontario
Hopital Laval - Institut universitaire de cardiologie et de pneumonologie
Québec, Quebec, G1V 4G5
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: Selective CFAE Targeting for Atrial Fibrillation (SELECT-AF)
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.
Read the detailed description
The purpose of this study is to compare a strategy of targeted CFAE ablation, focusing on regions of continuous electrical activity versus a strategy of generalized CFAE ablation in terms of (1) acute effects on AFCL (atrial fibrillation cycle length), AF regularization, and AF termination; (2) number and distribution of lesion sets delivered; and (3) long term effects on procedural outcome when combined with PVAI as a hybrid strategy.
- Conditions
- Atrial Fibrillation
- Being tested
- CFAE ablation
- Keywords
- paroxysmal, persistent, targeted, generalized, CFAE
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFAE ablationProcedure or surgery
Also called CFAE ablation (targeted vs. generalized), NaviStar ThermoCool Catheter, CARTO mapping system
CFAE ablation (targeted vs. generalized)
| Study group | Role | What they receive |
|---|---|---|
| (1) targeted CFAE ablation | Active comparator | Not described Receives: Procedure: CFAE ablation |
| (2) generalized CFAE ablation | Active comparator | Not described Receives: Procedure: CFAE ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
Secondary outcomes (4)
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.
Measured: Duration of ablation procedure (up to about 5 hours)
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.
Measured: 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
Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target
Measured: Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)
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.
Measured: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2011
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Hendricks, Study director, Biosense Webster, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926783
- Sponsor's protocol ID
- SELECT-AF
- Acronym
- SELECT-AF
- Status last verified
- Jun 2014
- First submitted
- 22 Jun 2009
- Last updated
- 10 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 24425420
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective CFAE Targeting for Atrial Fibrillation (SELECT-AF)
- ClinicalTrials.gov ID
- NCT00926783
- Acronym / sponsor ID
- SELECT-AF / SELECT-AF
- Conditions
- Atrial Fibrillation
- Keywords
- paroxysmal, persistent, targeted, generalized, CFAE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Posted 3 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to compare a strategy of targeted CFAE ablation, focusing on regions of continuous electrical activity versus a strategy of generalized CFAE ablation in terms of (1) acute effects on AFCL (atrial fibrillation cycle length), AF regularization, and AF termination; (2) number and distribution of lesion sets delivered; and (3) long term effects on procedural outcome when combined with PVAI as a hybrid strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (1) targeted CFAE ablation | Active comparator | Procedure: CFAE ablation |
| (2) generalized CFAE ablation | Active comparator | Procedure: CFAE ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CFAE ablationAlso: CFAE ablation (targeted vs. generalized), NaviStar ThermoCool Catheter, CARTO mapping systemCFAE ablation (targeted vs. generalized) | Procedure or surgery | (1) targeted CFAE ablation, (2) generalized CFAE ablation |
Primary outcome
Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.
Time frame: From day 91 to day 365 post first ablation procedure
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.
Total Radio-frequency (RF) Delivery Time During CFAE
Time frame: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
Total RF delivery time (minutes) is defined as the duration of the RF delivered per ablation site and totaled for each procedure.
4 secondary outcomes
Duration of Ablation Procedure
Time frame: Duration of ablation procedure (up to about 5 hours)
Fluoroscopy Time
Time frame: 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
Time frame: Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)
Incidence of Atrial Fibrillation (AF) Termination/Regularization
Time frame: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24425420Verma 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Hendricks study director
Biosense Webster, Inc.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CFAE ablation in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year. (time frame: From day 91 to day 365 post first ablation procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00926783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2014.