Atrial FibrillationRASTANCT00379301
Efficacy of Different Ablation Strategies for Controlling Atrial Fibrillation
A study testing Radiofrequency ablation in people with Atrial Fibrillation, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study involves treatment for atrial fibrillation (AF)-the most common heart condition in the US-where the upper chambers of the heart beat very fast and in a disorganized manner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients of age ≥ 30 years, undergoing their first ablation procedure that meet ACC / AHA defined criteria for persistent or permanent AF will be eligible to participate in the study. This includes patients with a history of AF episodes lasting at least 7 days or requiring at least 2 cardioversions.
Who cannot join
- Patients with paroxysmal AF (self-terminating episodes lasting < 7 day)
- Patients who have had a previous AF ablation procedure
- Pregnancy
- Failure to obtain informed consent
- Less than 30 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: Efficacy of Different Ablation Strategies in Achieving Long-Term Arrhythmia Control in Patients With Persistent or Permanent Atrial Fibrillation
This study involves treatment for atrial fibrillation (AF)-the most common heart condition in the US-where the upper chambers of the heart beat very fast and in a disorganized manner. This can be felt as palpitations, tiredness, shortness of breath and passing out, plus can lead to stroke, damage to the heart muscle and a shorter life span. Study participants will receive a common treatment for atrial fibrillation called radiofrequency ablation (RFA), where small lesions or "burns" are made inside the heart to cut off the abnormal impulses that cause AF. The purpose of this study is to compare the effectiveness of three different common ablation strategies in patients with persistent or permanent AF. Subjects will be randomized (like drawing straws) to be treated with one of the three strategies to see if there is a difference in how well atrial fibrillation is controlled after treatment.
Read the detailed description
In most cases, AF originates where the pulmonary veins (PV) enter the left upper chamber of the heart, known as the left atrium (LA). Common to the procedure in each arm of the study is pulmonary vein isolation (PVI) or ablation of tissue around the pulmonary vein entrances. After PVI, the procedure continues with ablation in other areas of the LA where similar abnormal impulses are found. The three strategies for continuing with ablation after PVI are described in the "Arms" section below.
- Conditions
- Atrial Fibrillation
- Being tested
- Radiofrequency ablation
- Keywords
- Atrial Fibrillation, A-Fib, AF, Persistent, Permanent, Pulmonary Vein Isolation, 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.
Radiofrequency ablationProcedure or surgery
Special catheters are inserted into blood vessels in the groin, then advanced into the left atrium of the heart. Radiofrequency (heat) energy is applied to small areas of heart tissue where electrical impulses that generate AF are found.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Pulmonary vein isolation (PVI) combined with ablation of documented non-PV triggers of atrial fibrillation --- (sites away from the pulmonary veins where consistent abnormal impulses that can trigger AF are identified during the procedure) Receives: Procedure: Radiofrequency ablation |
| Group 2 | Active comparator | PVI combined with ablation at documented sites of non-PV triggers, PLUS ablation at sites where non-PV triggers are commonly found Receives: Procedure: Radiofrequency ablation |
| Group 3 | Active comparator | PVI combined with ablation at documented sites of non-PV triggers and ablation at sites in the left atrium that demonstrate disorganized electrical impulses called complex fractionated electrograms (CFE). Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term (greater than 6 months) arrhythmia control in patients with persistent or permanent AF
Measured: 6 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2009
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Dixit, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379301
- Sponsor's protocol ID
- UPenn805173
- Acronym
- RASTA
- Status last verified
- Jun 2012
- First submitted
- 20 Sep 2006
- Last updated
- 14 Jun 2012
- Results posted
- No
Publications
Dixit S, Marchlinski FE, Lin D, Callans DJ, Bala R, Riley MP, Garcia FC, Hutchinson MD, Ratcliffe SJ, Cooper JM, Verdino RJ, Patel VV, Zado ES, Cash NR, Killian T, Tomson TT, Gerstenfeld EP. Randomized ablation strategies for the treatment of persistent atrial fibrillation: RASTA study. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):287-94. doi: 10.1161/CIRCEP.111.966226. Epub 2011 Dec 2.
PubMed 22139886
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Ablation Strategies in Achieving Long-Term Arrhythmia Control in Patients With Persistent or Permanent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00379301
- Acronym / sponsor ID
- RASTA / UPenn805173
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, A-Fib, AF, Persistent, Permanent, Pulmonary Vein Isolation, Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 21 Sep 2006 (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.
This study involves treatment for atrial fibrillation (AF)-the most common heart condition in the US-where the upper chambers of the heart beat very fast and in a disorganized manner. This can be felt as palpitations, tiredness, shortness of breath and passing out, plus can lead to stroke, damage to the heart muscle and a shorter life span. Study participants will receive a common treatment for atrial fibrillation called radiofrequency ablation (RFA), where small lesions or "burns" are made inside the heart to cut off the abnormal impulses that cause AF. The purpose of this study is to compare the effectiveness of three different common ablation strategies in patients with persistent or permanent AF. Subjects will be randomized (like drawing straws) to be treated with one of the three strategies to see if there is a difference in how well atrial fibrillation is controlled after treatment.
Detailed description
In most cases, AF originates where the pulmonary veins (PV) enter the left upper chamber of the heart, known as the left atrium (LA). Common to the procedure in each arm of the study is pulmonary vein isolation (PVI) or ablation of tissue around the pulmonary vein entrances. After PVI, the procedure continues with ablation in other areas of the LA where similar abnormal impulses are found. The three strategies for continuing with ablation after PVI are described in the "Arms" section below.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Radiofrequency ablationPulmonary vein isolation (PVI) combined with ablation of documented non-PV triggers of atrial fibrillation --- (sites away from the pulmonary veins where consistent abnormal impulses that can trigger AF are identified during the procedure) |
| Group 2 | Active comparator | Procedure: Radiofrequency ablationPVI combined with ablation at documented sites of non-PV triggers, PLUS ablation at sites where non-PV triggers are commonly found |
| Group 3 | Active comparator | Procedure: Radiofrequency ablationPVI combined with ablation at documented sites of non-PV triggers and ablation at sites in the left atrium that demonstrate disorganized electrical impulses called complex fractionated electrograms (CFE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients of age ≥ 30 years, undergoing their first ablation procedure that meet ACC / AHA defined criteria for persistent or permanent AF will be eligible to participate in the study. This includes patients with a history of AF episodes lasting at least 7 days or requiring at least 2 cardioversions.
Key exclusion criteria (5 listed)
- Patients with paroxysmal AF (self-terminating episodes lasting < 7 day)
- Patients who have had a previous AF ablation procedure
- Pregnancy
- Failure to obtain informed consent
- Less than 30 years old
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 |
|---|---|---|
| Radiofrequency ablationSpecial catheters are inserted into blood vessels in the groin, then advanced into the left atrium of the heart. Radiofrequency (heat) energy is applied to small areas of heart tissue where electrical impulses that generate AF are found. | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
Long-term (greater than 6 months) arrhythmia control in patients with persistent or permanent AF
Time frame: 6 - 12 months
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 14 Jun 2012.
- Results publication: PubMed 22139886Dixit S, Marchlinski FE, Lin D, Callans DJ, Bala R, Riley MP, Garcia FC, Hutchinson MD, Ratcliffe SJ, Cooper JM, Verdino RJ, Patel VV, Zado ES, Cash NR, Killian T, Tomson TT, Gerstenfeld EP. Randomized ablation strategies for the treatment of persistent atrial fibrillation: RASTA study. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):287-94. doi: 10.1161/CIRCEP.111.966226. Epub 2011 Dec 2.
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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.
Sanjay Dixit, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation in people with Atrial Fibrillation, run by University of Pennsylvania at 1 site 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 1 inclusion and 5 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 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Long-term (greater than 6 months) arrhythmia control in patients with persistent or permanent AF (time frame: 6 - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00379301, which also lists 1 linked publication.
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 14 Jun 2012.