Typical Atrial FlutterREDUCE AFNCT01710150
Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter
A study testing CTI ablation alone and CTI ablation and Pulmonary vein isolation (PVI) in people with Typical Atrial Flutter and Risk Factors With Future Development of Atrial Flutter, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation alone versus CTI ablation combined with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Typical Atrial Flutter, Risk Factors With Future Development of Atrial Flutter
- What is being tested?
- CTI ablation alone and CTI ablation and Pulmonary vein isolation (PVI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Aug 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients with typical AFLT confirmed by a 12-lead ECG that are referred for ablation and manifest ≥ 2 risk factors associated with future development of AF will be eligible to participate in the study.
- Risk factors for predicting future occurrence of AF will include:
- prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for study participation),
- LA size > 4.0 cm,
- left ventricular ejection fraction (LVEF) ≤ 50%,
- hypertension, and/or 5) obstructive sleep apnea.
Who cannot join
- Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment,
- inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure and
- failure to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Randomized Trial Comparing Long Term Occurrence of Atrial Arrhythmias Including Atrial Fibrillation (AF) and Thromboembolic Complications in Patients With Typical Atrial Flutter (AFLT) Undergoing Cavo-tricuspid Isthmus (CTI) Ablation Alone Versus CTI Ablation Combined With Pulmonary Vein Isolation (PVI).
The purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation alone versus CTI ablation combined with pulmonary vein isolation (PVI).
Read the detailed description
Typical Atrial Flutter (AFLT) is a common cardiac arrhythmia. Studies have demonstrated the safety and superiority of ablation procedure over antiarrhythmic drug (AAD) therapy. Long term freedom from typical AFLT has been consistently shown after successful ablation, but up to 30% of these patients can experience new onset of a different arrhythmia i.e., Atrial Fibrillation (AF). AF results from triggers in the back of the left upper chamber in the heart (left atrium - LA). These triggers typically arise from in and around the opening of the 4 veins (pulmonary veins - PVs) that bring blood from the lungs into the heart. The highest incidence of AF in patients undergoing ablation for typical AFLT was observed where the follow-up duration exceeded a year after the AFLT ablation. This would suggest that AF development in patients undergoing typical AFLT ablation is progressive and inevitable.
- Being tested
- CTI ablation alone, CTI ablation and Pulmonary vein isolation (PVI)
- Keywords
- typical aflutter (AFLT), CTI ablation, Atrial Fibrillation (AF), PVI
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTI ablation aloneProcedure or surgery
CTI ablation and Pulmonary vein isolation (PVI)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CTI ablation only | Placebo comparator | subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter Receives: Procedure: CTI ablation alone |
| CTI ablation and PVI. | Active comparator | subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation. Receives: Procedure: CTI ablation and Pulmonary vein isolation (PVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs).
Measured: 2 years
Secondary outcomes (1)
Occurrence of serious adverse events [CVE, pericardial effusion results in tamponade, development of PV stenosis (symptomatic or asymptomatic >70% reduction in PV diameter in ≥1 veins assessed by CT scan), left atrial-esophageal fistula and death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Lack of enrollment
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 Typical Atrial FlutterStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 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
- NCT01710150
- Sponsor's protocol ID
- REDUCE AF
- Acronym
- REDUCE AF
- Status last verified
- Apr 2017
- First submitted
- 11 Oct 2012
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mohanty S, Natale A, Mohanty P, DI Biase L, Trivedi C, Santangeli P, Bai R, Burkhardt JD, Gallinghouse GJ, Horton R, Sanchez JE, Hranitzky PM, Al-Ahmad A, Hao S, Hongo R, Beheiry S, Pelargonio G, Forleo G, Rossillo A, Themistoclakis S, Casella M, Russo AD, Tondo C, Dixit S. Pulmonary Vein Isolation to Reduce Future Risk of Atrial Fibrillation in Patients Undergoing Typical Flutter Ablation: Results from a Randomized Pilot Study (REDUCE AF). J Cardiovasc Electrophysiol. 2015 Aug;26(8):819-825. doi: 10.1111/jce.12688. Epub 2015 May 26.
PubMed 25884325
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Long Term Occurrence of Atrial Arrhythmias Including Atrial Fibrillation (AF) and Thromboembolic Complications in Patients With Typical Atrial Flutter (AFLT) Undergoing Cavo-tricuspid Isthmus (CTI) Ablation Alone Versus CTI Ablation Combined With Pulmonary Vein Isolation (PVI).
- ClinicalTrials.gov ID
- NCT01710150
- Acronym / sponsor ID
- REDUCE AF / REDUCE AF
- Keywords
- typical aflutter (AFLT), CTI ablation, Atrial Fibrillation (AF), PVI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Oct 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 purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation alone versus CTI ablation combined with pulmonary vein isolation (PVI).
Detailed description
Typical Atrial Flutter (AFLT) is a common cardiac arrhythmia. Studies have demonstrated the safety and superiority of ablation procedure over antiarrhythmic drug (AAD) therapy. Long term freedom from typical AFLT has been consistently shown after successful ablation, but up to 30% of these patients can experience new onset of a different arrhythmia i.e., Atrial Fibrillation (AF). AF results from triggers in the back of the left upper chamber in the heart (left atrium - LA). These triggers typically arise from in and around the opening of the 4 veins (pulmonary veins - PVs) that bring blood from the lungs into the heart. The highest incidence of AF in patients undergoing ablation for typical AFLT was observed where the follow-up duration exceeded a year after the AFLT ablation. This would suggest that AF development in patients undergoing typical AFLT ablation is progressive and inevitable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTI ablation only | Placebo comparator | Procedure: CTI ablation alonesubjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter |
| CTI ablation and PVI. | Active comparator | Procedure: CTI ablation and Pulmonary vein isolation (PVI)subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients with typical AFLT confirmed by a 12-lead ECG that are referred for ablation and manifest ≥ 2 risk factors associated with future development of AF will be eligible to participate in the study.
- prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for study participation),
- LA size > 4.0 cm,
- left ventricular ejection fraction (LVEF) ≤ 50%,
- hypertension, and/or 5) obstructive sleep apnea.
Key exclusion criteria (3 listed)
- Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment,
- inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure and
- failure to provide informed consent.
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 |
|---|---|---|
| CTI ablation alone | Procedure or surgery | CTI ablation only |
| CTI ablation and Pulmonary vein isolation (PVI) | Procedure or surgery | CTI ablation and PVI. |
Primary outcome
Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs).
Time frame: 2 years
1 secondary outcome
Occurrence of serious adverse events [CVE, pericardial effusion results in tamponade, development of PV stenosis (symptomatic or asymptomatic >70% reduction in PV diameter in ≥1 veins assessed by CT scan), left atrial-esophageal fistula and death
Time frame: 2 years
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 2 May 2017.
- Derived from this study: PubMed 25884325Mohanty S, Natale A, Mohanty P, DI Biase L, Trivedi C, Santangeli P, Bai R, Burkhardt JD, Gallinghouse GJ, Horton R, Sanchez JE, Hranitzky PM, Al-Ahmad A, Hao S, Hongo R, Beheiry S, Pelargonio G, Forleo G, Rossillo A, Themistoclakis S, Casella M, Russo AD, Tondo C, Dixit S. Pulmonary Vein Isolation to Reduce Future Risk of Atrial Fibrillation in Patients Undergoing Typical Flutter Ablation: Results from a Randomized Pilot Study (REDUCE AF). J Cardiovasc Electrophysiol. 2015 Aug;26(8):819-825. doi: 10.1111/jce.12688. Epub 2015 May 26.
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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.
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 CTI ablation alone and CTI ablation and Pulmonary vein isolation (PVI) in people with Typical Atrial Flutter and Risk Factors With Future Development of Atrial Flutter, 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 6 inclusion and 3 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 2 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 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. Some participants in this study may receive a placebo. 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 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?
Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs). (time frame: 2 years). 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 NCT01710150, 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 2 May 2017.