Paroxysmal Atrial FibrillationFIRMAT-PAFNCT01925885
Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF)
A study testing PVI Ablation and FIRM Ablation in people with Paroxysmal Atrial Fibrillation, run by Indiana University at 1 site in United States.
Trial summary
Hypothesis: Focal Impulse and Rotor Modulation (FIRM) will substantially reduce or eliminate clinical atrial fibrillation in subjects with accepted indications for catheter ablation of paroxysmal AF, compared to standard pulmonary vein isolation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- PVI Ablation and FIRM Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 23 Dec 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reported incidence of at least two (2) documented episodes of symptomatic paroxysmal atrial fibrillation (AF) during the six months preceding trial entry (at least one episode should be documented by rhythm strip or ECG).
- Attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping the medication (drug duration and dose will be documented).
- Left atrial size <55mm in largest dimension (typically atrial septum to carina of left pulmonary veins) as measured and image documented by preoperative imaging (CT or MRI)
- Anticoagulation therapy-Oral anticoagulation required (in the case of Warfarin, therapeutic International Normalized Ratio (INR) for at least three weeks prior to randomization) for those subjects who meet two or more of the following criteria:
- Age 65 years or older
- Diabetes
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- Prior stroke or transient ischemic attack
- Congestive heart failure
- Hypertension with systolic>165 mm Hg
- Left Ventricular Ejection Fraction ≥ 40% (obtained within 12 months prior to the procedure)
- Sustained AF-if the patient is not experiencing spontaneous, sustained AF (>10 min uninterrupted), sustained AF may be induced by burst atrial pacing with or without isoproterenol infusion in conventional clinical fashion.
Who cannot join
- Previous catheter or surgical left atrial ablation
- Structural heart disease of clinical significance including
- Congenital heart disease where either the underlying abnormality or its correction prohibits or increases the risk of ablation
- Myocardial infarction (MI) within the past three (3) months
- Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this study
- Atrial Septal Defect closure device; Left Atrial Appendage closure device; prosthetic mitral or tricuspid valve
Show all 28Show fewer
- Anaphylactic allergy to contrast media
- Atrial fibrillation secondary to electrolyte imbalance
- thyroid disease
- reversible non-cardiac cause
- Poor general health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, etc.)
- Reversible cause of atrial fibrillation (e.g. surgery, hyperthyroidism, pericarditis)
- Contraindication to heparin and warfarin/other new oral anticoagulants (e.g. dabigatran, rivaroxaban, apixaban [when available])
- History of pulmonary embolus within one year of enrollment
- Acute pulmonary edema
- Atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) performed within 72 hours of the procedure if deemed appropriate by the investigator
- Any history of a cerebrovascular disease-including stroke or Transient Ischemic Attack
- Any anticipation of cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
- History of documented thromboembolic event within the past one year
- Diagnosed atrial myxoma
- Significant pulmonary disease
- Acute illness or active systemic infection or sepsis
- Any history of blood clotting abnormalities or bleeding tendencies unrelated to supratherapeutic anticoagulation
- Life expectancy <365 days (12 months)
- Any intracardiac thrombus, tumor. or other abnormality that precludes safe catheter introduction or manipulation
- Continuous AF episode lasting >7 days immediately prior to the procedure without any sinus rhythm
- Patients who have previously undergone cardioversion are excluded from participation in the study unless there is documentation that cardioversion has been performed within 72 hours of episode onset
- Amiodarone use in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
- Hypothesis: Focal Impulse and Rotor Modulation (FIRM) will substantially reduce or eliminate clinical atrial fibrillation in subjects with accepted indications for catheter ablation of paroxysmal AF, compared to standard pulmonary vein isolation.
- Summary: This is a prospective randomized study to assess the safety and effectiveness of FIRM procedures only, versus standard Pulmonary Vein Isolation (PVI) procedures for the treatment of symptomatic paroxysmal atrial fibrillation.
Read the detailed description
A total of 188 subjects will be enrolled-subjects will be equally (1:1) randomized between those undergoing conventional atrial fibrillation ablation with confirmation of pulmonary vein isolation (PVI) versus those actively treated with the FIRM procedure without PVI.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- PVI Ablation, FIRM Ablation
- Keywords
- 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.
PVI AblationProcedure or surgery
Also called Ablation, Atrial Fibrillation, Arrhythmia, Radiofrequency Ablation
PVI ablation for atrial fibrillation specifically targets areas in the left atrium in the area just outside the pulmonary veins to eliminate triggers of atrial fibrillation.
FIRM AblationProcedure or surgery
Also called Ablation, Atrial Fibrillation, Arrhythmia, Radiofrequency Ablation
Ablation for atrial fibrillation specifically targets areas in the left or right atrium to eliminate areas that maintain atrial fibrillation without isolating the pulmonary veins
| Study group | Role | What they receive |
|---|---|---|
| PVI Ablation | Active comparator | Standard of care arm-pulmonary vein isolation (PVI)-involving moving the ablation catheter from point to point in a continuous line to surround the the orifices of the pulmonary veins in order to eliminate electrical conduction between the veins and left atrium. Receives: Procedure: PVI Ablation |
| FIRM Ablation | Experimental | FIRM ablation for paroxysmal atrial fibrillation at sites of rotors or focal impulse formation as designated by using the mapping algorithm of RhythmView Receives: Procedure: FIRM Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Ablation Success for Paroxysmal Atrial Fibrillation
- the termination of spontaneous or induced atrial fibrillation by ablation at an atrial fibrillation source arrhythmia location
- the slowing of the mean atrial fibrillation rate at least by 10% by ablation at an atrial fibrillation source arrhythmia
- evaluate safety and effectiveness of the FIRM procedures for the treatment of paroxysmal atrial fibrillation
- freedom from major adverse events related to the procedure within 7 days of the procedure
Measured: 1 week
Secondary outcomes (1)
Long Term Ablation Success for Paroxysmal Atrial Fibrillation
- freedom from atrial fibrillation recurrence (>30sec) from 3-12 months
- freedom from major adverse events related to the procedure within one year of the procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startSep 2013
- Primary completion23 Dec 2015
- Study completion23 Dec 2015
Why it stopped: •Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Topera, Medical
- Responsible party
- Sponsor
- Investigators
- John M Miller, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925885
- Sponsor's protocol ID
- IU-1302010649
- Acronym
- FIRMAT-PAF
- Status last verified
- Apr 2017
- First submitted
- 5 Aug 2013
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF)
- ClinicalTrials.gov ID
- NCT01925885
- Acronym / sponsor ID
- FIRMAT-PAF / IU-1302010649
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Atrial Arrhythmia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: •Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Topera, Medical
- Study start
- Sep 2013
- Primary completion
- 23 Dec 2015 (actual)
- Study completion
- 23 Dec 2015 (actual)
- First posted
- 20 Aug 2013 (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.
- Hypothesis: Focal Impulse and Rotor Modulation (FIRM) will substantially reduce or eliminate clinical atrial fibrillation in subjects with accepted indications for catheter ablation of paroxysmal AF, compared to standard pulmonary vein isolation.
- Summary: This is a prospective randomized study to assess the safety and effectiveness of FIRM procedures only, versus standard Pulmonary Vein Isolation (PVI) procedures for the treatment of symptomatic paroxysmal atrial fibrillation.
Detailed description
A total of 188 subjects will be enrolled-subjects will be equally (1:1) randomized between those undergoing conventional atrial fibrillation ablation with confirmation of pulmonary vein isolation (PVI) versus those actively treated with the FIRM procedure without PVI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI Ablation | Active comparator | Procedure: PVI AblationStandard of care arm-pulmonary vein isolation (PVI)-involving moving the ablation catheter from point to point in a continuous line to surround the the orifices of the pulmonary veins in order to eliminate electrical conduction between the veins and left atrium. |
| FIRM Ablation | Experimental | Procedure: FIRM AblationFIRM ablation for paroxysmal atrial fibrillation at sites of rotors or focal impulse formation as designated by using the mapping algorithm of RhythmView |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Reported incidence of at least two (2) documented episodes of symptomatic paroxysmal atrial fibrillation (AF) during the six months preceding trial entry (at least one episode should be documented by rhythm strip or ECG).
- Attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping the medication (drug duration and dose will be documented).
- Left atrial size <55mm in largest dimension (typically atrial septum to carina of left pulmonary veins) as measured and image documented by preoperative imaging (CT or MRI)
- Anticoagulation therapy-Oral anticoagulation required (in the case of Warfarin, therapeutic International Normalized Ratio (INR) for at least three weeks prior to randomization) for those subjects who meet two or more of the following criteria:
- Left Ventricular Ejection Fraction ≥ 40% (obtained within 12 months prior to the procedure)
Key exclusion criteria (28 listed)
- Previous catheter or surgical left atrial ablation
- Structural heart disease of clinical significance including
- Congenital heart disease where either the underlying abnormality or its correction prohibits or increases the risk of ablation
- Myocardial infarction (MI) within the past three (3) months
- Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this 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 |
|---|---|---|
| PVI AblationAlso: Ablation, Atrial Fibrillation, Arrhythmia, Radiofrequency AblationPVI ablation for atrial fibrillation specifically targets areas in the left atrium in the area just outside the pulmonary veins to eliminate triggers of atrial fibrillation. | Procedure or surgery | PVI Ablation |
| FIRM AblationAlso: Ablation, Atrial Fibrillation, Arrhythmia, Radiofrequency AblationAblation for atrial fibrillation specifically targets areas in the left or right atrium to eliminate areas that maintain atrial fibrillation without isolating the pulmonary veins | Procedure or surgery | FIRM Ablation |
Primary outcome
Acute Ablation Success for Paroxysmal Atrial Fibrillation
Time frame: 1 week
* the termination of spontaneous or induced atrial fibrillation by ablation at an atrial fibrillation source arrhythmia location * the slowing of the mean atrial fibrillation rate at least by 10% by ablation at an atrial fibrillation source arrhythmia * evaluate safety and effectiveness of the FIRM procedures for the treatment of paroxysmal atrial fibrillation * freedom from major adverse events related to the procedure within 7 days of the procedure
1 secondary outcome
Long Term Ablation Success for Paroxysmal Atrial Fibrillation
Time frame: 1 year
Results and safety
The study was stopped early (reason given: •Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
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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.
John M Miller, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI Ablation and FIRM Ablation in people with Paroxysmal Atrial Fibrillation, run by Indiana University 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 11 inclusion and 28 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: stopped early, as of the sponsor's last update on 5 Apr 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. 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 stopped early (reason given: •Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated). Results are not available in the source record.
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?
Acute Ablation Success for Paroxysmal Atrial Fibrillation (time frame: 1 week). 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 5 Apr 2017.