Atrial FibrillationNCT00231296
Safety and Efficacy of CryoCor™ Cryoablation for PAF
A study testing Cardiac CryoCor Cryoablation System and Medical management in people with Atrial Fibrillation, run by Boston Scientific Corporation at 24 sites in United States.
Trial summary
A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cardiac CryoCor Cryoablation System and Medical management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 24 sitesUnited States
- Study dates
- Nov 2004to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 3 episodes of PAF within 6 months
- Refractory to at least one drug
- Therapeutic anticoagulation
- Signed informed consent
Who cannot join
- Persistent AF
- Structural heart disease
- Prior ablation
- Contraindication present
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Emory University
Atlanta, Georgia, 30308
Austin Heart, PA
Austin, Texas, 78756
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Chicago Hospitals
Chicago, Illinois, 60637
Genesis Health
Davenport, Iowa, 52803
Iowa Heart Center
Des Moines, Iowa, 50309
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
University of Florida
Gainesville, Florida, 32611
Penn State Heart and Vascular Institute
Hershey, Pennsylvania, 17033
Methodist Debakey Heart Center
Houston, Texas, 77030
Cardiology Associates of Kentucky
Lexington, Kentucky, 40504
Heart Care Associates
Milwaukee, Wisconsin, 53215
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Drexel University
Philadelphia, Pennsylvania, 19102
Oregon Health and Science University
Portland, Oregon, 97239
University of Rochester Medical Center
Rochester, New York, 14642
Regional Cardiology Associates
Sacramento, California, 95819
UCSD Medical Center
San Diego, California, 92103
UCSF Medical
San Francisco, California, 94143
Tacoma General
Tacoma, Washington, 98415
University of South Florida
Tampa, Florida, 33606
Carle Heart Center
Urbana, Illinois, 61801
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Clinical Study to Evaluate the Safety and Efficacy of the CryoCor(TM)Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation
A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF
Read the detailed description
The purpose of this prospective, randomized multi-center clinical study is to establish the benefits of the CryoCor(TM) Cardiac Cryoablation System for treating symptomatic paroxysmal atrial fibrillation (PAF) in comparison to treatment with anti-arrhythmic medications alone. This study also evaluates the safety profile of the CryoCor(TM) Cardiac Cryoablation System when used in this same setting.
- Conditions
- Atrial Fibrillation
- Being tested
- Cardiac CryoCor Cryoablation System, Medical management
- Keywords
- cryoablation, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CryoCor Cryoablation SystemDevice
Also called Ablation with the CryoCor ablation catheter
Treatment with CryoCor Cardiac Cryoablation system
Medical managementDrug
Also called AAD treatment
Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications
| Study group | Role | What they receive |
|---|---|---|
| Treatment with CryoCor Cryoablation System | Active comparator | Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF. Receives: Device: Cardiac CryoCor Cryoablation System |
| Treatment with standard medical therapy | Active comparator | Intervention includes treatment with ant-arrhythmic medications alone. Receives: Drug: Medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of intervention
Measured: 12 months
Recurrence of PAF
Measured: 12 months
Secondary outcomes (5)
Change in QOL as measured by SF-36 Health Survey
Changes compared to baseline will be measured over a period of 12 months
Measured: 12 months
Change in QOL as measured by Symptom Checklist
Changes compared to baseline will be measured over a period of 12 months
Measured: 12 months
Change in QOL as measured by Arrhythmia Severity scale
Changes compared to baseline will be measured over a period of 12 months
Measured: 12 months
Change in luminal PV measurements
Measured: 6 months
Time to treatment failure, post resolution period
Time to treatment failure, defined as event monitor documented recurrent atrial fibrillation, post resolution period.
Measured: Post resolution period (12 months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startNov 2004
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Feld, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231296
- Sponsor's protocol ID
- GL-AF-02
- Status last verified
- May 2017
- First submitted
- 30 Sep 2005
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of the CryoCor(TM)Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00231296
- Acronym / sponsor ID
- GL-AF-02
- Conditions
- Atrial Fibrillation
- Keywords
- cryoablation, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2004 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF
Detailed description
The purpose of this prospective, randomized multi-center clinical study is to establish the benefits of the CryoCor(TM) Cardiac Cryoablation System for treating symptomatic paroxysmal atrial fibrillation (PAF) in comparison to treatment with anti-arrhythmic medications alone. This study also evaluates the safety profile of the CryoCor(TM) Cardiac Cryoablation System when used in this same setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with CryoCor Cryoablation System | Active comparator | Device: Cardiac CryoCor Cryoablation SystemIntervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF. |
| Treatment with standard medical therapy | Active comparator | Drug: Medical managementIntervention includes treatment with ant-arrhythmic medications alone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 3 episodes of PAF within 6 months
- Refractory to at least one drug
- Therapeutic anticoagulation
- Signed informed consent
Key exclusion criteria (4 listed)
- Persistent AF
- Structural heart disease
- Prior ablation
- Contraindication present
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 |
|---|---|---|
| Cardiac CryoCor Cryoablation SystemAlso: Ablation with the CryoCor ablation catheterTreatment with CryoCor Cardiac Cryoablation system | Device | Treatment with CryoCor Cryoablation System |
| Medical managementAlso: AAD treatmentMedical management- treatment with standard medical therapy, which includes anti-arrhythmic medications | Drug | Treatment with standard medical therapy |
Primary outcome
Safety profile of intervention
Time frame: 12 months
Recurrence of PAF
Time frame: 12 months
5 secondary outcomes
Change in QOL as measured by SF-36 Health Survey
Time frame: 12 months
Change in QOL as measured by Symptom Checklist
Time frame: 12 months
Change in QOL as measured by Arrhythmia Severity scale
Time frame: 12 months
Change in luminal PV measurements
Time frame: 6 months
Time to treatment failure, post resolution period
Time frame: Post resolution period (12 months follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Gregory Feld, MD principal investigator
University of California, San Diego
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac CryoCor Cryoablation System and Medical management in people with Atrial Fibrillation, run by Boston Scientific Corporation at 24 sites in United States.
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 4 inclusion and 4 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 4 May 2017. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety profile of intervention (time frame: 12 months). 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 4 May 2017.