Atrial FibrillationNCT00408200
A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation
A study testing propafenone; flecainide; sotalol; dofetilide and Radiofrequency catheter ablation in people with Atrial Fibrillation, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The purpose of this study is to examine the overall effectiveness of anti-arrhythmic medicines (to control heart rhythm) prescribed after an ablation procedure for atrial fibrillation. 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?
- propafenone; flecainide; sotalol; dofetilide and Radiofrequency catheter ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2006to Jun 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients meeting ACC/AHA criteria for paroxysmal atrial fibrillation (episodes typically last no more than 7 days and are self-terminating)
- Eligible for pulmonary vein isolation
- Able to tolerate antiarrhythmic medication
Who cannot join
- Age <18
- Persistent or permanent atrial fibrillation (episodes last >7 days and require cardioversion)
- Antiarrhythmic treatment for indication other than atrial fibrillation
- Contraindication or intolerance to all antiarrhythmic medications
- Primary physician unwilling to withhold antiarrhythmic drugs for duration of the study
- Failure to obtain informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Trial to Assess the Utility of Empirical Anti-Arrhythmic Drug Therapy to Prevent Atrial Arrhythmia During the 6 Weeks Following Pulmonary Vein Isolation to Treat Paroxysmal Atrial Fibrillation
The purpose of this study is to examine the overall effectiveness of anti-arrhythmic medicines (to control heart rhythm) prescribed after an ablation procedure for atrial fibrillation.
Read the detailed description
Atrial fibrillation (AF) is the most common heart rhythm disorder in the US and it is associated with shortness of breath, palpitations, stroke occurrence and increased mortality. Traditional treatment for AF includes anticoagulation, drugs that slow the heart rate and antiarrhythmic agents. More recently, catheter based treatments to address atrial fibrillation have been developed, which involves using radiofrequency energy to isolate the arrhythmogenic foci localized in the pulmonary veins.
During the first weeks following pulmonary vein isolation (PVI), it is not unusual for patients to experience early recurrences of atrial fibrillation or atrial tachycardia due to irritability from the ablation. While these arrhythmias tend to resolve over time, it is nevertheless standard practice to prescribe antiarrhythmic drugs for the first 2-3 months after the intervention to prevent these early recurrences. However, the efficacy of this practice has never been formally evaluated. In addition, we have identified a small group of patients whose atrial tachycardias have terminated after cessation of antiarrhythmic therapy, suggesting that proarrhythmia from these agents may promote reentrant tachycardias in some patients. We therefore designed a study protocol that will evaluate the usefulness of short term antiarrhythmic drug therapy in order to prevent atrial fibrillation and atrial tachycardia episodes during the first 6 weeks following PVI.
The target population of the study includes all patients with paroxysmal atrial fibrillation referred for PVI. After the ablation procedure, patients will be randomized to receive or not receive antiarrhythmic drugs for a period of 6 weeks. Arrhythmia occurrence during this period will be monitored via twice daily transtelephonic monitoring. Clinical visits including a physical exam and 12 lead ECG recording will be scheduled at 6 weeks. The primary endpoint of the study will be a composite endpoint including 1) atrial arrhythmias persisting > 24 hours or requiring initiation of antiarrhythmic therapy 2) need for cardioversion/hospital admission 3) need for repeat ablation or 4) adverse outcome/intolerance of antiarrhythmic agent requiring drug cessation or change during the 6 week follow up period.
- Conditions
- Atrial Fibrillation
- Being tested
- propafenone; flecainide; sotalol; dofetilide, Radiofrequency catheter ablation
- Keywords
- Atrial fibrillation, Atrial arrhythmia
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propafenone; flecainide; sotalol; dofetilideDrug
Above drugs prescribed per established guidelines for treatment of AF
Radiofrequency catheter ablationDevice
A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.
| Study group | Role | What they receive |
|---|---|---|
| AAD:YES | Other | Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below. Receives: Drug: propafenone; flecainide; sotalol; dofetilide; Device: Radiofrequency catheter ablation |
| AAD:NO | Other | Subjects do not receive membrane-active anti-arrhythmic medications after ablation. Receives: Device: Radiofrequency catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug
Measured: 6 weeks
Secondary outcomes (1)
Freedom From Atrial Arrhythmia at 6 Months Post Procedure.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionApr 2008
- Study completionJun 2008
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.
- Publications (2)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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward P. Gerstenfeld, MD, Principal investigator, University of Pennsylvania Health System - Cardiac Electrophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408200
- Sponsor's protocol ID
- 805346HUP
- Status last verified
- Jun 2012
- First submitted
- 1 Dec 2006
- Last updated
- 7 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Roux JF, Zado E, Callans DJ, Garcia F, Lin D, Marchlinski FE, Bala R, Dixit S, Riley M, Russo AM, Hutchinson MD, Cooper J, Verdino R, Patel V, Joy PS, Gerstenfeld EP. Antiarrhythmics After Ablation of Atrial Fibrillation (5A Study). Circulation. 2009 Sep 22;120(12):1036-40. doi: 10.1161/CIRCULATIONAHA.108.839639. Epub 2009 Sep 8.
PubMed 19738139Leong-Sit P, Roux JF, Zado E, Callans DJ, Garcia F, Lin D, Marchlinski FE, Bala R, Dixit S, Riley M, Hutchinson MD, Cooper J, Russo AM, Verdino R, Gerstenfeld EP. Antiarrhythmics after ablation of atrial fibrillation (5A Study): six-month follow-up study. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):11-4. doi: 10.1161/CIRCEP.110.955393. Epub 2010 Nov 13.
PubMed 21076158
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Assess the Utility of Empirical Anti-Arrhythmic Drug Therapy to Prevent Atrial Arrhythmia During the 6 Weeks Following Pulmonary Vein Isolation to Treat Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00408200
- Acronym / sponsor ID
- 805346HUP
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Atrial arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 6 Dec 2006 (estimated)
- Results
- Posted 7 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the overall effectiveness of anti-arrhythmic medicines (to control heart rhythm) prescribed after an ablation procedure for atrial fibrillation.
Detailed description
Atrial fibrillation (AF) is the most common heart rhythm disorder in the US and it is associated with shortness of breath, palpitations, stroke occurrence and increased mortality. Traditional treatment for AF includes anticoagulation, drugs that slow the heart rate and antiarrhythmic agents. More recently, catheter based treatments to address atrial fibrillation have been developed, which involves using radiofrequency energy to isolate the arrhythmogenic foci localized in the pulmonary veins.
During the first weeks following pulmonary vein isolation (PVI), it is not unusual for patients to experience early recurrences of atrial fibrillation or atrial tachycardia due to irritability from the ablation. While these arrhythmias tend to resolve over time, it is nevertheless standard practice to prescribe antiarrhythmic drugs for the first 2-3 months after the intervention to prevent these early recurrences. However, the efficacy of this practice has never been formally evaluated. In addition, we have identified a small group of patients whose atrial tachycardias have terminated after cessation of antiarrhythmic therapy, suggesting that proarrhythmia from these agents may promote reentrant tachycardias in some patients. We therefore designed a study protocol that will evaluate the usefulness of short term antiarrhythmic drug therapy in order to prevent atrial fibrillation and atrial tachycardia episodes during the first 6 weeks following PVI.
The target population of the study includes all patients with paroxysmal atrial fibrillation referred for PVI. After the ablation procedure, patients will be randomized to receive or not receive antiarrhythmic drugs for a period of 6 weeks. Arrhythmia occurrence during this period will be monitored via twice daily transtelephonic monitoring. Clinical visits including a physical exam and 12 lead ECG recording will be scheduled at 6 weeks. The primary endpoint of the study will be a composite endpoint including 1) atrial arrhythmias persisting > 24 hours or requiring initiation of antiarrhythmic therapy 2) need for cardioversion/hospital admission 3) need for repeat ablation or 4) adverse outcome/intolerance of antiarrhythmic agent requiring drug cessation or change during the 6 week follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AAD:YES | Other | Drug: propafenone; flecainide; sotalol; dofetilide, Device: Radiofrequency catheter ablationSubjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below. |
| AAD:NO | Other | Device: Radiofrequency catheter ablationSubjects do not receive membrane-active anti-arrhythmic medications after ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients meeting ACC/AHA criteria for paroxysmal atrial fibrillation (episodes typically last no more than 7 days and are self-terminating)
- Eligible for pulmonary vein isolation
- Able to tolerate antiarrhythmic medication
Key exclusion criteria (6 listed)
- Age <18
- Persistent or permanent atrial fibrillation (episodes last >7 days and require cardioversion)
- Antiarrhythmic treatment for indication other than atrial fibrillation
- Contraindication or intolerance to all antiarrhythmic medications
- Primary physician unwilling to withhold antiarrhythmic drugs for duration of the study
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 |
|---|---|---|
| propafenone; flecainide; sotalol; dofetilideAbove drugs prescribed per established guidelines for treatment of AF | Drug | AAD:YES |
| Radiofrequency catheter ablationA special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates. | Device | AAD:NO, AAD:YES |
Primary outcome
Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug
Time frame: 6 weeks
1 secondary outcome
Freedom From Atrial Arrhythmia at 6 Months Post Procedure.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19738139Roux JF, Zado E, Callans DJ, Garcia F, Lin D, Marchlinski FE, Bala R, Dixit S, Riley M, Russo AM, Hutchinson MD, Cooper J, Verdino R, Patel V, Joy PS, Gerstenfeld EP. Antiarrhythmics After Ablation of Atrial Fibrillation (5A Study). Circulation. 2009 Sep 22;120(12):1036-40. doi: 10.1161/CIRCULATIONAHA.108.839639. Epub 2009 Sep 8.
- Derived from this study: PubMed 21076158Leong-Sit P, Roux JF, Zado E, Callans DJ, Garcia F, Lin D, Marchlinski FE, Bala R, Dixit S, Riley M, Hutchinson MD, Cooper J, Russo AM, Verdino R, Gerstenfeld EP. Antiarrhythmics after ablation of atrial fibrillation (5A Study): six-month follow-up study. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):11-4. doi: 10.1161/CIRCEP.110.955393. Epub 2010 Nov 13.
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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.
Edward P. Gerstenfeld, MD principal investigator
University of Pennsylvania Health System - Cardiac Electrophysiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propafenone; flecainide; sotalol; dofetilide and Radiofrequency catheter ablation in people with Atrial Fibrillation, run by University of Pennsylvania at 2 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 3 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: finished, as of the sponsor's last update on 7 Mar 2013. 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. 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 7 Mar 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?
Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug (time frame: 6 weeks). 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 NCT00408200, which also lists 2 linked publications.
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 7 Mar 2013.