Typical Atrial FlutterPhase 3CONTACT_AFLNCT01401361
Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System
A Phase 3 study testing Treatment Arm in people with Typical Atrial Flutter, run by Abbott Medical Devices at 20 sites in 2 countries.
Trial summary
To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter Does not result into unacceptable risk of intra-procedural composite serious adverse events and, Does not affect efficacy of the ablation… 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?
- Treatment Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Oct 2011to Sep 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 (cavo-tricuspid isthmus dependent)
- If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then they need to be controlled on their medication for at least 3 months. If a 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 intracardiac 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
20 sites in 2 countries.
20 sites in 2 countries
United States19 sites
Emory University Hospital
Atlanta, Georgia, 30322
Cardiology, P.C.
Birmingham, Alabama, 35211
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Presbyterian Hospital
Charlotte, North Carolina, 28204
University of Chicago
Chicago, Illinois, 60637
Ohio Health Research Institute - GMC
Columbus, Ohio, 43215
Texas Health Research & Education Institute
Dallas, Texas, 75231
Aurora Denver Cardiology
Denver, Colorado, 80012
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Hartford Hospital
Hartford, Connecticut, 06102
Memorial Hermann Hospital
Houston, Texas, 77030
St. Luke's Episcopal Hospital
Houston, Texas, 77030
St. Vincent's Hospital
Jacksonville, Florida, 32204
Ochsner Medical Center
New Orleans, Louisiana, 70121
New York University Langone Medical Center - Tisch Hospital
New York, New York, 10016
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Virginia Cardiovascular Specialists
Richmond, Virginia, 23229
University of Rochester
Rochester, New York, 14642
Scott & White Memorial Hospital
Temple, Texas, 76508
Canada1 site
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, H1T 1C8
About this study
Official title: Clinical Evaluation of Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction With EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter
To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter
- Does not result into unacceptable risk of intra-procedural composite serious adverse events and,
- Does not affect efficacy of the ablation procedure The study will also evaluate the
Read the detailed description
This will be a prospective, multi-center and non-randomized study. All enrolled patients who meet the eligibility criteria will receive ablation therapy for typical atrial flutter using the Contact Therapy™ Cool Path™ Cardiac Ablation System. Historical data from published (PMA P060019 Cool Path) , reported (IDE G090109 Cool Path Duo) and published literature on Atrial Flutter RF ablation studies is used to determine performance goals for primary study endpoints and derive the sample size. In addition, the following analyses will be performed in the study
- Validation of ECI against conventional methods of assessing tip tissue contact and
- Ancillary analysis to assess the relationship between the ECI and study outcomes. Subjects will undergo two follow up visits at day 10 and month 3 post procedure. The following assessments will be performed during these visits:
- ECG
- Query regarding adverse events since the last visit
- Assessment of anti-arrhythmic and anti-coagulation medication
- Query regarding recurrence or repeat ablation for typical atrial flutter
- Conditions
- Typical Atrial Flutter
- Being tested
- Treatment Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ArmDevice
Also called Ablation with Contact Therapy Cool Path system
The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Atrial Flutter RF Ablation treatment with the Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement. Receives: Device: Treatment Arm |
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 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 investigational system.
Measured: 30 minutes
Secondary outcomes (1)
Secondary Efficacy
Secondary efficacy / Chronic success is defined as freedom from recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence will be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmic medication (Class 1a,
1c, III) during the 3 months 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 posted25 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionSep 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry Chinitz, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401361
- Sponsor's protocol ID
- 90064772
- Acronym
- CONTACT_AFL
- Status last verified
- Jan 2019
- First submitted
- 21 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 Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction With EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter
- ClinicalTrials.gov ID
- NCT01401361
- Acronym / sponsor ID
- CONTACT_AFL / 90064772
- Conditions
- Typical Atrial Flutter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Posted 23 Dec 2013
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 the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter
- Does not result into unacceptable risk of intra-procedural composite serious adverse events and,
- Does not affect efficacy of the ablation procedure The study will also evaluate the
Detailed description
This will be a prospective, multi-center and non-randomized study. All enrolled patients who meet the eligibility criteria will receive ablation therapy for typical atrial flutter using the Contact Therapy™ Cool Path™ Cardiac Ablation System. Historical data from published (PMA P060019 Cool Path) , reported (IDE G090109 Cool Path Duo) and published literature on Atrial Flutter RF ablation studies is used to determine performance goals for primary study endpoints and derive the sample size. In addition, the following analyses will be performed in the study
- Validation of ECI against conventional methods of assessing tip tissue contact and
- Ancillary analysis to assess the relationship between the ECI and study outcomes. Subjects will undergo two follow up visits at day 10 and month 3 post procedure. The following assessments will be performed during these visits:
- ECG
- Query regarding adverse events since the last visit
- Assessment of anti-arrhythmic and anti-coagulation medication
- Query regarding recurrence or repeat ablation for typical atrial flutter
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: Treatment ArmAtrial Flutter RF Ablation treatment with the Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement. |
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 antiarrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then they need to be controlled on their medication for at least 3 months. If a 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 |
|---|---|---|
| Treatment ArmAlso: Ablation with Contact Therapy Cool Path systemThe investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement . | 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 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 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.
Larry Chinitz, MD principal investigator
NYU Langone Health
20 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 Treatment Arm in people with Typical Atrial Flutter, run by Abbott Medical Devices at 20 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 20 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 23 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 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.