Persistent Atrial FibrillationREDO-FIRMNCT02799043
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
A study testing Standard PVI and FIRM-Guided Procedure and PVI in people with Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 24 sites in 4 countries.
Trial summary
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
- What is being tested?
- Standard PVI and FIRM-Guided Procedure and PVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 24 sitesin 4 countries
- Study dates
- Jun 2016to Jul 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experiencing at least one (1) documented episode of spontaneous persistent or paroxysmal atrial fibrillation during the last 3 months by rhythm strip/ECG.
- One (1) previous AF ablation (PVI-only - any technology) after Jan-01-2013, but NOT within the last 3 months.
- Left atrial diameter < 6.0 cm via transthoracic echo or transesophageal echo; or <6.5 cm via CT or MRI with 6 months prior to the procedure.
- Sustained spontaneous or induced AF (>5 min uninterrupted).
Who cannot join
- Presence of structural heart disease with clinical significance
- NYHA Class IV
- Ejection fraction < 35%
- Previous AF ablation within the last 3 months
- ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker.
- History of myocardial infarction (MI) within the past three (3) months
- Atrial clot/thrombus noted within 72 hours of the procedure
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
United States12 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Loyola University
Chicago, Illinois, 60153
Northwestern University - Bluhm Cardiovascular Institute
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43210
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Virginia Heart
Falls Church, Virginia, 22042
Broward Health
Fort Lauderdale, Florida, 33316
St. Vincent's HealthCare
Jacksonville, Florida, 32216
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Arizona Heart Rhythm Research Cente
Phoenix, Arizona, 85016
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Ventura Cardiology Consultants
Ventura, California, 93003
Germany10 sites
Ruhr University Bochum - Heart and Diabetes Center North Rhine-Westphalia
Bad Oeynhausen
UKB (Unfallkrankenhaus Berlin)
Berlin
Klinikum Coburg
Coburg, Bavaria
Praxisklinik Herz und Gefäße Dresden
Dresden
Kardiocentrum Frankfurt
Frankfurt, Main
Furth Medical Clinic for Heart and Lung Diseases
Fürth, Bavaria
Leipzig Heart Institute GmbH
Leipzig, Saxony
Luebeck University Heart Center
Lübeck, Schleswig-Holstein
The Dr. Müller Kliniken
Munich, Bavaria
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, Brandenburg
Netherlands1 site
Medical Center Rotterdam (Erasmus MC)
Rotterdam, South Holland
About this study
Official title: Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
Read the detailed description
The hypothesis of this study was that Focal Impulse and Rotor Modulation (FIRM) guided procedures will eliminate the source of clinical arrhythmias in subjects with clinical indications for repeat AF ablation procedures.
This study is a prospective, multicenter, randomized, controlled study to assess the safety and effectiveness of FIRM procedures followed by ablation including pulmonary vein isolation versus a standard conventional procedure including pulmonary vein isolation for the redo-treatment of persistent or paroxysmal atrial fibrillation after one failed previous pulmonary vein isolation.
- Being tested
- Standard PVI, FIRM-Guided Procedure and PVI
- Keywords
- FIRMap, Rotor, FIRM-guided procedure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PVIProcedure or surgery
Also called Pulmonary vein isolation, Ablation, Arrhythmia, Atrial fibrillation Mapping
Standard PVI procedure without FIRMap.
FIRM-Guided Procedure and PVIProcedure or surgery
Also called Pulmonary vein isolation, Atrial fibrillation Mapping, FIRMap
| Study group | Role | What they receive |
|---|---|---|
| Standard PVI | Active comparator | Standard catheter ablation including pulmonary vein isolation (PVI) procedure. Receives: Procedure: Standard PVI |
| FIRM-guided Procedure and PVI | Experimental | FIRM-guided procedure followed by PVI. Receives: Procedure: FIRM-Guided Procedure and PVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure.
Single procedure freedom from recurrence from 3-12 months post procedure
Measured: 12 months post procedure
Freedom From Serious Adverse Events Related to the Procedure
Freedom from any procedure-related serious adverse event from 0-10 days post procedure
Measured: 10-day post procedure
Freedom From Serious Adverse Events Related to the Procedure
Freedom from any procedure-related serious adverse event from 0-12 months post procedure
Measured: 12-month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2020
- Study completionJul 2020
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.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivek Reddy, MD, Principal investigator, MOUNT SINAI HOSPITALStefan G. Spitzer, MD, Principal investigator, Praxisklinik Herz und Gefäße Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799043
- Sponsor's protocol ID
- REDO-FIRM
- Acronym
- REDO-FIRM
- Status last verified
- Sep 2024
- First submitted
- 2 Jun 2016
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)
- ClinicalTrials.gov ID
- NCT02799043
- Acronym / sponsor ID
- REDO-FIRM / REDO-FIRM
- Keywords
- FIRMap, Rotor, FIRM-guided procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
Detailed description
The hypothesis of this study was that Focal Impulse and Rotor Modulation (FIRM) guided procedures will eliminate the source of clinical arrhythmias in subjects with clinical indications for repeat AF ablation procedures.
This study is a prospective, multicenter, randomized, controlled study to assess the safety and effectiveness of FIRM procedures followed by ablation including pulmonary vein isolation versus a standard conventional procedure including pulmonary vein isolation for the redo-treatment of persistent or paroxysmal atrial fibrillation after one failed previous pulmonary vein isolation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard PVI | Active comparator | Procedure: Standard PVIStandard catheter ablation including pulmonary vein isolation (PVI) procedure. |
| FIRM-guided Procedure and PVI | Experimental | Procedure: FIRM-Guided Procedure and PVIFIRM-guided procedure followed by PVI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experiencing at least one (1) documented episode of spontaneous persistent or paroxysmal atrial fibrillation during the last 3 months by rhythm strip/ECG.
- One (1) previous AF ablation (PVI-only - any technology) after Jan-01-2013, but NOT within the last 3 months.
- Left atrial diameter < 6.0 cm via transthoracic echo or transesophageal echo; or <6.5 cm via CT or MRI with 6 months prior to the procedure.
- Sustained spontaneous or induced AF (>5 min uninterrupted).
Key exclusion criteria (7 listed)
- Presence of structural heart disease with clinical significance
- NYHA Class IV
- Ejection fraction < 35%
- Previous AF ablation within the last 3 months
- ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker.
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 |
|---|---|---|
| Standard PVIAlso: Pulmonary vein isolation, Ablation, Arrhythmia, Atrial fibrillation MappingStandard PVI procedure without FIRMap. | Procedure or surgery | Standard PVI |
| FIRM-Guided Procedure and PVIAlso: Pulmonary vein isolation, Atrial fibrillation Mapping, FIRMap | Procedure or surgery | FIRM-guided Procedure and PVI |
Primary outcome
Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure.
Time frame: 12 months post procedure
Single procedure freedom from recurrence from 3-12 months post procedure
Freedom From Serious Adverse Events Related to the Procedure
Time frame: 10-day post procedure
Freedom from any procedure-related serious adverse event from 0-10 days post procedure
Freedom From Serious Adverse Events Related to the Procedure
Time frame: 12-month post procedure
Freedom from any procedure-related serious adverse event from 0-12 months post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Vivek Reddy, MD principal investigator
MOUNT SINAI HOSPITAL
Stefan G. Spitzer, MD principal investigator
Praxisklinik Herz und Gefäße Dresden, Germany
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard PVI and FIRM-Guided Procedure and PVI in people with Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 24 sites in 4 countries.
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 7 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Germany, Belgium, Netherlands. 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 19 Sep 2024). 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?
Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure. (time frame: 12 months post procedure). The study lists 3 primary outcomes in all. 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 19 Sep 2024.