Atrial FibrillationPhase 3PROPOSENCT01173796
Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes
A Phase 3 study testing catheter ablation in people with Atrial Fibrillation and Perimitral Flutter, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
Trial summary
This prospective, randomized study aims to compare the impact of ablation of perimitral flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of additional triggers, on procedure outcome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Perimitral Flutter
- What is being tested?
- catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2011
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with previous AF ablation presenting with PMFL and recurrent AF
- Age: 18- 75 years
- Willingness and ability to give written informed consent
- Therapeutic INR for at least 4 weeks prior to the procedure
Who cannot join
- Reversible causes of AF such as pericarditis and hyperthyroidism
- Documented intra-atrial thrombus, tumor or any other abnormality which prevents easy catheter manipulation
- Enrollment in another clinical study
- Any other terminal illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas
About this study
This prospective, randomized study aims to compare the impact of ablation of perimitral flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of additional triggers, on procedure outcome.
Read the detailed description
Background: In recent years, catheter ablation has been accepted as the treatment-of-choice for drug-refractory atrial fibrillation (AF). It is centered around isolating pulmonary veins (PVs) and its success rate in curing AF is very high (56%-85%) (1). However, despite isolation of this dominant source of triggers, recurrent tachyarrhythmia is the major complication of this procedure with peri-mitral atrial flutter (PMFL) being the most common macro-reentrant arrhythmia in context of AF ablation (2). These often drug-refractory arrhythmias are frequently associated with more severe symptoms than the original AF (3) and warrant the necessity for redo-ablation.
This study aims to compare the impact of two different redo-ablation strategies on the procedure outcome; (1) ablation of the perimitral flutter only and (2) cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers.
Study method: A total number of 65 AF patients presenting for redo-ablation and PMFL will be randomized to perimitral flutter ablation only or cardioversion and re-isolation (PVI) plus ablation of additional triggers. Additional triggers will be identified with the help of post-ablation drug provocation with isoproterenol. Patients will enter a follow-up period of 12 months after the ablation procedure, when they will be monitored for recurrence of arrhythmia detected either by in-clinic or remote device interrogation at 1, 3, 6 and 12 month post-procedure.
- Conditions
- Atrial Fibrillation, Perimitral Flutter
- Being tested
- 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.
catheter ablationProcedure or surgery
perimitral flutter ablation by blocking the mitral isthmus
catheter ablationProcedure or surgery
cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers
| Study group | Role | What they receive |
|---|---|---|
| PMFL ablation | Experimental | Radio-frequency catheter ablation of the mitral isthmus only Receives: Procedure: catheter ablation |
| Repeat PVAI and triggers ablation | Experimental | cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers Receives: Procedure: catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy
Measured: 1 year
Secondary outcomes (1)
Total number of hospitalizations during the study period Change in quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2011
- Study completionSep 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
- Investigators
- Andrea Natale, MD, Principal investigator, Texas cardia Arrhythmia Institute, St.David's Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173796
- Sponsor's protocol ID
- TCAI-PROPOSE
- Acronym
- PROPOSE
- Status last verified
- Jul 2012
- First submitted
- 21 Jun 2010
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bai R, Di Biase L, Mohanty P, Dello Russo A, Casella M, Pelargonio G, Themistoclakis S, Mohanty S, Elayi CS, Sanchez J, Burkhardt JD, Horton R, Gallinghouse GJ, Bailey SM, Bonso A, Beheiry S, Hongo RH, Raviele A, Tondo C, Natale A. Ablation of perimitral flutter following catheter ablation of atrial fibrillation: impact on outcomes from a randomized study (PROPOSE). J Cardiovasc Electrophysiol. 2012 Feb;23(2):137-44. doi: 10.1111/j.1540-8167.2011.02182.x. Epub 2011 Sep 28.
PubMed 21955215
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes
- ClinicalTrials.gov ID
- NCT01173796
- Acronym / sponsor ID
- PROPOSE / TCAI-PROPOSE
- Conditions
- Atrial Fibrillation, Perimitral Flutter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Aug 2010 (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 prospective, randomized study aims to compare the impact of ablation of perimitral flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of additional triggers, on procedure outcome.
Detailed description
Background: In recent years, catheter ablation has been accepted as the treatment-of-choice for drug-refractory atrial fibrillation (AF). It is centered around isolating pulmonary veins (PVs) and its success rate in curing AF is very high (56%-85%) (1). However, despite isolation of this dominant source of triggers, recurrent tachyarrhythmia is the major complication of this procedure with peri-mitral atrial flutter (PMFL) being the most common macro-reentrant arrhythmia in context of AF ablation (2). These often drug-refractory arrhythmias are frequently associated with more severe symptoms than the original AF (3) and warrant the necessity for redo-ablation.
This study aims to compare the impact of two different redo-ablation strategies on the procedure outcome; (1) ablation of the perimitral flutter only and (2) cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers.
Study method: A total number of 65 AF patients presenting for redo-ablation and PMFL will be randomized to perimitral flutter ablation only or cardioversion and re-isolation (PVI) plus ablation of additional triggers. Additional triggers will be identified with the help of post-ablation drug provocation with isoproterenol. Patients will enter a follow-up period of 12 months after the ablation procedure, when they will be monitored for recurrence of arrhythmia detected either by in-clinic or remote device interrogation at 1, 3, 6 and 12 month post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMFL ablation | Experimental | Procedure: catheter ablationRadio-frequency catheter ablation of the mitral isthmus only |
| Repeat PVAI and triggers ablation | Experimental | Procedure: catheter ablationcardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with previous AF ablation presenting with PMFL and recurrent AF
- Age: 18- 75 years
- Willingness and ability to give written informed consent
- Therapeutic INR for at least 4 weeks prior to the procedure
Key exclusion criteria (4 listed)
- Reversible causes of AF such as pericarditis and hyperthyroidism
- Documented intra-atrial thrombus, tumor or any other abnormality which prevents easy catheter manipulation
- Enrollment in another clinical study
- Any other terminal illness
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 |
|---|---|---|
| catheter ablationperimitral flutter ablation by blocking the mitral isthmus | Procedure or surgery | PMFL ablation |
| catheter ablationcardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers | Procedure or surgery | Repeat PVAI and triggers ablation |
Primary outcome
Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy
Time frame: 1 year
1 secondary outcome
Total number of hospitalizations during the study period Change in quality of life
Time frame: 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 11 Jul 2012.
- Derived from this study: PubMed 21955215Bai R, Di Biase L, Mohanty P, Dello Russo A, Casella M, Pelargonio G, Themistoclakis S, Mohanty S, Elayi CS, Sanchez J, Burkhardt JD, Horton R, Gallinghouse GJ, Bailey SM, Bonso A, Beheiry S, Hongo RH, Raviele A, Tondo C, Natale A. Ablation of perimitral flutter following catheter ablation of atrial fibrillation: impact on outcomes from a randomized study (PROPOSE). J Cardiovasc Electrophysiol. 2012 Feb;23(2):137-44. doi: 10.1111/j.1540-8167.2011.02182.x. Epub 2011 Sep 28.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Andrea Natale, MD principal investigator
Texas cardia Arrhythmia Institute, St.David's Medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing catheter ablation in people with Atrial Fibrillation and Perimitral Flutter, run by Texas Cardiac Arrhythmia Research Foundation 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 4 inclusion and 4 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 11 Jul 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy (time frame: 1 year). 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 NCT01173796, 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 11 Jul 2012.