Typical Atrial FlutterFLEXION-AFLNCT01408485
Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter
A study testing Therapy™ Cool Flex™ Irrigated Ablation System in people with Typical Atrial Flutter, run by Abbott Medical Devices at 24 sites in 2 countries.
Trial summary
To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Typical Atrial Flutter
- What is being tested?
- Therapy™ Cool Flex™ Irrigated Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Nov 2011to Oct 2012
- Phase
- Interventional
- 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
- A signed written Informed Consent
- Presence of typical atrial flutter (cavo-tricuspid isthmus dependent)
- If subjects are receiving anti-arrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply
- One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months
- In good physical health
- 18 years of age or older
- Agree to comply with follow-up visits and evaluation
Who cannot join
- Prior typical atrial flutter ablation treatment
- Pregnancy
- Atypical flutter or scar flutter (non isthmus dependent)
- Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment
- A recent myocardial infarction within 3 months of the intended procedure date
- Permanent coronary sinus pacing lead
Show all 11Show fewer
- Clinically significant Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve
- Evidence of intra-cardiac thrombus or a history of clotting disorders
- Participation in another investigational study
- Cardiac surgery within 1 month prior to the intended procedure date
- Allergy or contraindication to Heparin
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States22 sites
Clinical Tex Research, LLC/DBA PharmaTex Research
Amarillo, Texas, 79106
St. Joseph's Hospital
Atlanta, Georgia, 30342
Heart Hospital of Austin
Austin, Texas, 78756
Lahey Clinic Medical Center
Burlington, Massachusetts, 01835
Ohio State University Medical Center
Columbus, Ohio, 43210
Washington Hospital Center
Georgetown, Maryland, 20010
Methodist Hospital Research Institute
Houston, Texas, 77030
Cleveland Clinic / Cardiovascular Associates of Cleveland
Mayfield Heights, Ohio, 44124
Jersey Shore Universty Medical Center
Neptune City, New Jersey, 07753
Mount Sinai School of Medicine
New York, New York, 10029
Summit - Cardiovascular Consultants Med Group, Inc.
Oakland, California, 94609
Adventist Health / Florida Hospital
Orlando, Florida, 32803
Huntington Memorial / Foothill Cardiology
Pasadena, California, 91105
St. Joseph's Hospital-Heart Rhythm Specialists, PC
Phoenix, Arizona, 85013
Regional Cardiology Associates
Sacramento, California, 95819
Guthrie-Robert Packer Hospital
Sayre, Pennsylvania, 18840
Sacred Heart Med Center
Springfield, Oregon, 97477
Tampa General Hospital
Tampa, Florida, 33606
Scott & White Memorial Hospital
Temple, Texas, 76508
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Community Memorial Hospital
Ventura, California, 93006
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Canada2 sites
Institut de Cardiologie de Quebec (Hopital Laval)
Québec, G1V 4G5
VCAT / Royal Jubilee
Victoria, British Columbia, V8R 4R2
About this study
Official title: Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter
To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.
Read the detailed description
This will be a prospective, multi-center and non-randomized study. All treated patients will receive ablation therapy for typical atrial flutter using the TherapyTM Cool FlexTM Irrigated Ablation System. Historical data from combined published (PMA P060019 Cool Path) and reported (IDE G090109 Cool Path Duo) Atrial Flutter studies will be used to determine performance goals for study endpoints.
- Conditions
- Typical Atrial Flutter
- Being tested
- Therapy™ Cool Flex™ Irrigated Ablation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy™ Cool Flex™ Irrigated Ablation SystemDevice
The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:
- Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter
- IBI 1500T9 V1.43 RF Generator
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Radio-frequency cardiac ablation for treatment of isthmus-dependant atrial flutter using the Therapy™ Cool Flex™ Irrigated Ablation System Receives: Device: Therapy™ Cool Flex™ Irrigated Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure
Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.
Measured: 7 days
Primary Efficacy
Primary efficacy or acute success is defined as achievement of bi-directional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.
Measured: 30 minutes
Secondary outcomes (1)
Secondary Efficacy
Secondary efficacy or chronic success is defined as freedom from recurrence of typical atrial flutter 3 mos. post ablation. Flutter recurrence will be documented on an ECG. Repeat ablations, new antiarrhythmia medications or increase in the existing anti-arrhythmic medications during the 3 mos. post ablation are considered chronic failures.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionOct 2012
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.
- Other trials for Typical Atrial FlutterStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raul Weiss, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408485
- Sponsor's protocol ID
- 90067869
- Acronym
- FLEXION-AFL
- Status last verified
- Jan 2019
- First submitted
- 22 Jul 2011
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter
- ClinicalTrials.gov ID
- NCT01408485
- Acronym / sponsor ID
- FLEXION-AFL / 90067869
- Conditions
- Typical Atrial Flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Posted 23 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.
Detailed description
This will be a prospective, multi-center and non-randomized study. All treated patients will receive ablation therapy for typical atrial flutter using the TherapyTM Cool FlexTM Irrigated Ablation System. Historical data from combined published (PMA P060019 Cool Path) and reported (IDE G090109 Cool Path Duo) Atrial Flutter studies will be used to determine performance goals for study endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Therapy™ Cool Flex™ Irrigated Ablation SystemRadio-frequency cardiac ablation for treatment of isthmus-dependant atrial flutter using the Therapy™ Cool Flex™ Irrigated Ablation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A signed written Informed Consent
- Presence of typical atrial flutter (cavo-tricuspid isthmus dependent)
- If subjects are receiving anti-arrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply
- One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months
- In good physical health
Key exclusion criteria (11 listed)
- Prior typical atrial flutter ablation treatment
- Pregnancy
- Atypical flutter or scar flutter (non isthmus dependent)
- Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment
- A recent myocardial infarction within 3 months of the intended procedure date
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 |
|---|---|---|
| Therapy™ Cool Flex™ Irrigated Ablation SystemThe investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: * Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter * IBI 1500T9 V1.43 RF Generator | Device | Treatment Arm |
Primary outcome
Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure
Time frame: 7 days
Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.
Primary Efficacy
Time frame: 30 minutes
Primary efficacy or acute success is defined as achievement of bi-directional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.
1 secondary outcome
Secondary Efficacy
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Raul Weiss, MD principal investigator
Ohio State University
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy™ Cool Flex™ Irrigated Ablation System in people with Typical Atrial Flutter, run by Abbott Medical Devices at 24 sites in 2 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 7 inclusion and 11 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 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?
Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure (time frame: 7 days). 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?
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 15 Feb 2019.