Atrial FibrillationCAP-AFNCT00889681
Continued Access Protocol
A study testing Arctic Front Cardiac Cryoablation System in people with Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 10 sites in United States.
Trial summary
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. 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?
- Arctic Front Cardiac Cryoablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2009to Oct 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must fulfill ALL of the following criteria:
- Documented PAF:
- diagnosis of paroxysmal atrial fibrillation (PAF) (Section 9.1.18, General Protocol Terminology), AND
- 2 or more episodes of AF during the 3 months preceding the Consent Date, at least 1 of which must be documented with a tracing
- 18 and 75 years of age
- Failure for the treatment of AF (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of PAF: flecainide, propafenone, sotalol or dofetilide.
Who cannot join
- ANY of the following is regarded as a criterion for excluding a subject from the study:
- Any previous left atrial (LA) ablation (except permissible retreatment subjects)
- Any previous LA surgery
- Current intracardiac thrombus (can be treated after thrombus is resolved)
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis
Show all 34Show fewer
- Pre-existing hemidiaphragmatic paralysis
- Anteroposterior LA diameter > 5.5 cm by TTE
- Presence of any cardiac valve prosthesis
- Clinically significant mitral valve regurgitation or stenosis
- Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
- Unstable angina
- Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
- Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
- NYHA class III or IV congestive heart failure
- Left ventricular ejection fraction (LVEF) < 40%
- 2º (Type II) or 3º atrioventricular block
- Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- Brugada syndrome
- Long QT syndrome
- Arrhythmogenic right ventricular dysplasia
- Sarcoidosis
- Hypertrophic cardiomyopathy
- Known cryoglobulinemia
- Uncontrolled hyperthyroidism
- Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
- Any woman known to be pregnant
- Any woman without freedom from pregnancy as demonstrated by one or more of the following conditions:
- negative β-HCG test within 7 days prior to Start Date
- history of surgical sterilization
- postmenopausal and free of menses for at least 12 months.
- Life expectancy less than one (1) year
- Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study
- Unwilling or unable to comply fully with study procedures and follow-up
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Piedmont Hospital
Atlanta, Georgia, 30309
Massachusetts General Hospital
Boston, Massachusetts, 02114
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226
Inova Research Center
Falls Church, Virginia, 22042
Cedars Sinai Medical Center
Los Angeles, California, 90048
Banner Good Samaritan
Phoenix, Arizona, 85006
Virginia Commonwealth University Health System
Richmond, Virginia, 23219
Mayo Clinic
Rochester, Minnesota, 55905
Stanford Hospital & Clinical
Stanford, California, 94305-5288
Bay Heart Group
Tampa, Florida, 33607
About this study
Official title: CAP-AF: Continued Access Protocol for the Evaluation of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.
Read the detailed description
- To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects free from one or more primary safety outcome measures-Cryoablation Procedure Events (CPEs) and Major Atrial Fibrillation Events (MAFEs), in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
- To evaluate the effectiveness of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects with success in the primary effectiveness outcome measure of Long Term Clinical Success (LTCS) in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
- To evaluate the acute performance of the modified Arctic Front® Cardiac CryoAblation Catheter System for comparison with the Arctic Front® Cardiac CryoAblation Catheter System used in the PS-023 STOP AF Pivotal Trial.
- Conditions
- Atrial Fibrillation
- Being tested
- Arctic Front Cardiac Cryoablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arctic Front Cardiac Cryoablation SystemDevice
Also called Arctic Front® Catheter Ref# 2AF232 & 2AF282, Manual Retraction Kit Ref# 20MRK, Freezor MAX Catheter Ref # 239F3 & 239F5, Console Ref # 106A2
The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | All study subjects will be receive cryo ablation with the experimental devices and, optionally, an Atrial Fibrillation Drug. Receives: Device: Arctic Front Cardiac Cryoablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cryoablation Procedure Events (CPEs)
Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.
Measured: 365 days
Acute Procedural Success (APS)
Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.
Measured: At the conclusion of the cryoablation procedure
Freedom From Major Atrial Fibrillation Events (MAFE)
Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.
Measured: 365 days
Long-term Clinical Success
Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2013
- Study completionOct 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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Douglas Packer, MD, Principal investigator, Mayo Clinic, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889681
- Sponsor's protocol ID
- CAP PS-024
- Acronym
- CAP-AF
- Status last verified
- Sep 2018
- First submitted
- 24 Apr 2009
- Last updated
- 19 Sep 2018
- 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 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAP-AF: Continued Access Protocol for the Evaluation of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00889681
- Acronym / sponsor ID
- CAP-AF / CAP PS-024
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Mar 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Posted 25 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.
Detailed description
- To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects free from one or more primary safety outcome measures-Cryoablation Procedure Events (CPEs) and Major Atrial Fibrillation Events (MAFEs), in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
- To evaluate the effectiveness of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects with success in the primary effectiveness outcome measure of Long Term Clinical Success (LTCS) in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
- To evaluate the acute performance of the modified Arctic Front® Cardiac CryoAblation Catheter System for comparison with the Arctic Front® Cardiac CryoAblation Catheter System used in the PS-023 STOP AF Pivotal Trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Device: Arctic Front Cardiac Cryoablation SystemAll study subjects will be receive cryo ablation with the experimental devices and, optionally, an Atrial Fibrillation Drug. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented PAF:
- 18 and 75 years of age
- Failure for the treatment of AF (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of PAF: flecainide, propafenone, sotalol or dofetilide.
Key exclusion criteria (34 listed)
- Any previous left atrial (LA) ablation (except permissible retreatment subjects)
- Any previous LA surgery
- Current intracardiac thrombus (can be treated after thrombus is resolved)
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis
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 |
|---|---|---|
| Arctic Front Cardiac Cryoablation SystemAlso: Arctic Front® Catheter Ref# 2AF232 & 2AF282, Manual Retraction Kit Ref# 20MRK, Freezor MAX Catheter Ref # 239F3 & 239F5, Console Ref # 106A2The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation. | Device | Ablation |
Primary outcome
Cryoablation Procedure Events (CPEs)
Time frame: 365 days
Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.
Acute Procedural Success (APS)
Time frame: At the conclusion of the cryoablation procedure
Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.
Freedom From Major Atrial Fibrillation Events (MAFE)
Time frame: 365 days
Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.
Long-term Clinical Success
Time frame: 180 days
Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- 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.
Douglas Packer, MD principal investigator
Mayo Clinic, Rochester, MN
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arctic Front Cardiac Cryoablation System in people with Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 10 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 6 inclusion and 34 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 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Yes. Results are posted in the registry (first posted 25 Apr 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?
Cryoablation Procedure Events (CPEs) (time frame: 365 days). The study lists 4 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 Sep 2018.