Atrial FibrillationPhase 4CABALNCT01505296
Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation
A Phase 4 study testing Antiarrhythmic drug and Catheter ablation in people with Atrial Fibrillation, run by Valley Health System at 2 sites in 2 countries.
Trial summary
The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Antiarrhythmic drug and Catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2011to Jan 2014
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy
Who cannot join
- Previous treatment with Class IC or class III AAD
- Previous AF ablation procedure
- Congestive heart failure (NYHA III-IV functional class)
- Left Ventricle ejection fraction less than 35%
- Left atrial diameter > 55mm
- Unwillingness to participate
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Randomized Comparison of Catheter Ablation Versus Anti-arrhythmic Drug Therapy in Patients With Recently Diagnosed Paroxysmal Atrial Fibrillation as Assessed by a Continuous Implantable Monitor
The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy.
Read the detailed description
Randomized, multicenter clinical trial comparing medical therapy (Group I) with ablation therapy(Group II). Randomization will be determined by opening a sealed envelope. All patients will be implanted with an implantable loop recorder and followed every three months.
- Conditions
- Atrial Fibrillation
- Being tested
- Antiarrhythmic drug, Catheter ablation
- Keywords
- Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiarrhythmic drugDrug
Also called Rhythmol, Tambocor, Betapace, Tikosyn
propafenone, flecainide, sotalol, dofetilide
Catheter ablationProcedure or surgery
Also called Thermocool
Complete PVI
| Study group | Role | What they receive |
|---|---|---|
| Antiarrhythmic drug | Active comparator | Class I or III antiarrhythmic drug Receives: Drug: Antiarrhythmic drug |
| Catheter ablation | Experimental | Pulmonary vein isolation Receives: Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of AF burden
The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)
Measured: 4 months
Secondary outcomes (1)
All-death death
All-cause death, thromboembolic events, hospitalizations, procedural complications, drug adverse effects, and number of crossovers
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Never initiated
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valley Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Principal investigator, Jonathan Steinberg,MD, Valley Health System
- Investigators
- Jonathan Steinberg, MD, Principal investigator, Valley Health SystemEvegny Pokushalou, MD, Principal investigator, State Resarch Institute of Circulation Pathology, Novosibirsk, Siberia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505296
- Sponsor's protocol ID
- BWI-IIS-0143
- Acronym
- CABAL
- Status last verified
- Dec 2014
- First submitted
- 28 Dec 2011
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Catheter Ablation Versus Anti-arrhythmic Drug Therapy in Patients With Recently Diagnosed Paroxysmal Atrial Fibrillation as Assessed by a Continuous Implantable Monitor
- ClinicalTrials.gov ID
- NCT01505296
- Acronym / sponsor ID
- CABAL / BWI-IIS-0143
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Valley Health SystemUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- Dec 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Jan 2012 (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.
The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy.
Detailed description
Randomized, multicenter clinical trial comparing medical therapy (Group I) with ablation therapy(Group II). Randomization will be determined by opening a sealed envelope. All patients will be implanted with an implantable loop recorder and followed every three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiarrhythmic drug | Active comparator | Drug: Antiarrhythmic drugClass I or III antiarrhythmic drug |
| Catheter ablation | Experimental | Procedure: Catheter ablationPulmonary vein isolation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy
Key exclusion criteria (6 listed)
- Previous treatment with Class IC or class III AAD
- Previous AF ablation procedure
- Congestive heart failure (NYHA III-IV functional class)
- Left Ventricle ejection fraction less than 35%
- Left atrial diameter > 55mm
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 |
|---|---|---|
| Antiarrhythmic drugAlso: Rhythmol, Tambocor, Betapace, Tikosynpropafenone, flecainide, sotalol, dofetilide | Drug | Antiarrhythmic drug |
| Catheter ablationAlso: ThermocoolComplete PVI | Procedure or surgery | Catheter ablation |
Primary outcome
Percentage of AF burden
Time frame: 4 months
The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)
1 secondary outcome
All-death death
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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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.
Jonathan Steinberg, MD principal investigator
Valley Health System
Evegny Pokushalou, MD principal investigator
State Resarch Institute of Circulation Pathology, Novosibirsk, Siberia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antiarrhythmic drug and Catheter ablation in people with Atrial Fibrillation, run by Valley Health System at 2 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 1 inclusion and 6 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: withdrawn, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Russia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of AF burden (time frame: 4 months). 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 16 Dec 2014.