Typical Atrial FlutterPhase 3NCT00984204
Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
A Phase 3 study testing Therapy Cool Path Duo in people with Typical Atrial Flutter, run by Abbott Medical Devices at 22 sites in 2 countries.
Trial summary
The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's). 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 Path Duo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Oct 2009to Jan 2012
- Phase
- Phase 3
- 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 (cavotricuspid isthmus dependent)
- If subjects are receiving antiarrhythmic 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
- Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve (i.e. significant)
- Evidence of intracardiac thrombus or a history of clotting disorders
- Participation in another investigational study
- Cardiac surgery within 1 month of the intended procedure date
- Allergy or contraindication to Heparin
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States20 sites
Virginia Hospital Center
Arlington, Virginia, 22205
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Ohio State Medical
Columbus, Ohio, 43210
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75226
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Moses Cone Hospital
Greensboro, North Carolina, 27401
St. Luke's Episcopal Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
Kansas University Medical Center
Kansas City, Kansas, 66160
Central Baptist Hospital
Lexington, Kentucky, 40503
Cardiovascular Associates of Cleveland
Mayfield Heights, Ohio, 44124
Ochsner Medical Center
New Orleans, Louisiana, 70121
Providence St. Vincent Medical Center
Portland, Oregon, 97225
University of Rochester
Rochester, New York, 14642
Regional Cardiology Associates
Sacramento, California, 95819
Washington Adventist Hospital
Takoma Park, Maryland, 20912
Scott & White Memorial Hospital
Temple, Texas, 76508
Main Line Health Center/Lankenau
Wynnewood, Pennsylvania, 19096
Canada2 sites
Institut de Cardiologie de Quebec
Québec, G1V 4G5
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria, British Columbia, V8R 4R2
About this study
The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).
Read the detailed description
This is a prospective, multi-center, non-randomized study (historical data as control) for the evaluating the safety and efficacy of Therapy TM Cool PathTM
Duo Ablation System for the treatment of typical atrial flutter (Cavo-triscupid isthmus dependent)
- Conditions
- Typical Atrial Flutter
- Being tested
- Therapy Cool Path Duo
- Keywords
- cavo-tricuspid dependent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy Cool Path DuoDevice
All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Device: Therapy Cool Path Duo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness.
Measured: 7 days
Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained.
Measured: 30 mins
Secondary outcomes (1)
Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure
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 posted25 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionJan 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984204
- Sponsor's protocol ID
- 90030638
- Status last verified
- Feb 2019
- First submitted
- 22 Sep 2009
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
- ClinicalTrials.gov ID
- NCT00984204
- Acronym / sponsor ID
- 90030638
- Conditions
- Typical Atrial Flutter
- Keywords
- cavo-tricuspid dependent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Posted 20 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).
Detailed description
This is a prospective, multi-center, non-randomized study (historical data as control) for the evaluating the safety and efficacy of Therapy TM Cool PathTM
Duo Ablation System for the treatment of typical atrial flutter (Cavo-triscupid isthmus dependent)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Therapy Cool Path Duo |
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 (cavotricuspid isthmus dependent)
- If subjects are receiving antiarrhythmic 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 Path DuoAll patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter. | Device | Treatment arm |
Primary outcome
Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness.
Time frame: 7 days
Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained.
Time frame: 30 mins
1 secondary outcome
Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure
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 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Therapy Cool Path Duo in people with Typical Atrial Flutter, run by Abbott Medical Devices at 22 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 19 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 22 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 20 Dec 2013). 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 Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness. (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 19 Feb 2019.