Persistent Atrial FibrillationREAFFIRMNCT02274857

Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures

A study testing Standard PVI Ablation and FIRM-Guided Procedure and PVI in people with Persistent Atrial Fibrillation, run by Abbott Medical Devices at 18 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Persistent Atrial Fibrillation
What is being tested?: Standard PVI Ablation 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: 350 participants
Where: 18 sitesin 3 countries
Study dates: Oct 2014to 10 Nov 2018
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

At least two (2) documented episodes of persistent atrial fibrillation during prior 3 months
Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic medications
Left atrial diameter < 6.0 cm

Who cannot join

Previous AF Ablation
Presence of structural heart disease
New York Heart Association (NYHA) Class IV.
Ejection fraction < 35%.
History of myocardial infarction (MI) within the past three months.

Trial locations and contacts

18 sites in 3 countries.

Country

City, postcode or hospital

18 sites in 3 countries

United States10 sites

The Johns Hopkins Hospital
Baltimore, Maryland
The Ohio State University
Columbus, Ohio, 43210
Hackensack UMC
Hackensack, New Jersey
Indiana University - Krannert Institute of Cardiology
Indianapolis, Indiana, 46202
St. Vincent Hospital
Indianapolis, Indiana, 46260
Loyola University Medical Center
Maywood, Illinois, 60153
Weill Medical College at Cornell University
New York, New York, 10065
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
Arizona Heart Rhythm Center
Phoenix, Arizona, 85013
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania

Other trials in United States

Germany7 sites

Herz- und Diabeteszentrum Bad Oeynhausen
Bad Oeynhausen, Minden-Lübbecke, 32545
Unfallkrankenhaus Berlin
Berlin, 12683
Klinikum Coburg GmbH
Coburg, 96450
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
Dresden, 01099
Städtisches Klinikum Karlsruhe gGmbH
Karlsruhe
Leipzig Heart Institute GmbH
Leipzig, 04289
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, 14471

Other trials in Germany

Netherlands1 site

Erasmus Medical Center
Rotterdam

Other trials in Netherlands

About this study

Official title: Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)

Conditions: Persistent Atrial Fibrillation
Being tested: Standard PVI Ablation, FIRM-Guided Procedure and PVI
Keywords: Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap), Rotor, FIRM-guided procedure, REAFFIRM
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 PVI AblationProcedure or surgery
Also called Pulmonary vein isolation, Ablation, Arrhythmia, Persistent atrial fibrillation
Standard PVI procedure without FIRMap.
FIRM-Guided Procedure and PVIProcedure or surgery
Also called Pulmonary vein isolation, Ablation, Arrhythmia, Persistent atrial fibrillation
FIRM-guided procedure followed by conventional ablation including PVI.

Study groups in NCT02274857
Study group	Role	What they receive
Standard PVI Ablation	Active comparator	Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF. Receives: Procedure: Standard PVI Ablation
FIRM-guided Procedure and PVI	Experimental	FIRM-guided procedure followed by standard catheter ablation including 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 Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure
Measured: Within 7-10 days of the Procedure
Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.
Measured: 3-month follow up
Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.
Measured: 3-12 months post study treatment
Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure
Measured: 3 to 12 months post study treatment

Secondary outcomes (1)

Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts
Measured: Immediately post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201410 Nov 2018

First posted24 Oct 2014 (estimated)
Study startOct 2014
Primary completion10 Nov 2018
Study completion10 Nov 2018

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: 350 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02274857
Sponsor's protocol ID: REAFFIRM
Acronym: REAFFIRM
Status last verified: Feb 2020
First submitted: 22 Oct 2014
Last updated: 7 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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All Persistent Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)
ClinicalTrials.gov ID: NCT02274857
Acronym / sponsor ID: REAFFIRM / REAFFIRM
Conditions: Persistent Atrial Fibrillation
Keywords: Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap), Rotor, FIRM-guided procedure, REAFFIRM
Study type: Interventional
Recruitment status: Completed
Enrolment: 350 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Oct 2014 (actual)
Primary completion: 10 Nov 2018 (actual)
Study completion: 10 Nov 2018 (actual)
First posted: 24 Oct 2014 (estimated)
Results: Posted 7 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard PVI Ablation	Active comparator	Procedure: Standard PVI AblationStandard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
FIRM-guided Procedure and PVI	Experimental	Procedure: FIRM-Guided Procedure and PVIFIRM-guided procedure followed by standard catheter ablation including PVI.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

At least two (2) documented episodes of persistent atrial fibrillation during prior 3 months
Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic medications
Left atrial diameter < 6.0 cm

Key exclusion criteria (5 listed)

Previous AF Ablation
Presence of structural heart disease
New York Heart Association (NYHA) Class IV.
Ejection fraction < 35%.
History of myocardial infarction (MI) within the past three months.

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 PVI AblationAlso: Pulmonary vein isolation, Ablation, Arrhythmia, Persistent atrial fibrillationStandard PVI procedure without FIRMap.	Procedure or surgery	Standard PVI Ablation
FIRM-Guided Procedure and PVIAlso: Pulmonary vein isolation, Ablation, Arrhythmia, Persistent atrial fibrillationFIRM-guided procedure followed by conventional ablation including PVI.	Procedure or surgery	FIRM-guided Procedure and PVI

Primary outcome

Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure
Time frame: Within 7-10 days of the Procedure
Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.
Time frame: 3-month follow up
Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.
Time frame: 3-12 months post study treatment
Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure
Time frame: 3 to 12 months post study treatment

1 secondary outcome

Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts
Time frame: Immediately post procedure

Results and safety

Results posted to the registry on 7 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard PVI Ablation	179	159
FIRM-guided Procedure and PVI	171	165

Primary outcome: Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure

Time frame: Within 7-10 days of the Procedure. Number. Unit: % of participants

Measure	Standard PVI Ablation n = 179	FIRM-guided Procedure and PVI n = 171
Value	92.7	88.9

Standard PVI Ablation vs FIRM-guided Procedure and PVI: p = 0.2179, Chi-squared

Population analysed: Intent to Treat (ITT) group, defined as subject randomized to a treatment group who had a mapping and/or ablation catheter inserted

Primary outcome: Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.

Time frame: 3-month follow up. Number. Unit: % of participants

Measure	Standard PVI Ablation n = 179	FIRM-guided Procedure and PVI n = 171
Value	76.9	71.8

Standard PVI Ablation vs FIRM-guided Procedure and PVI: p = 0.2782, Chi-squared

Population analysed: ITT: each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted Per Protocol: those subjects in the ITT group who completed all follow-up visits and had no major protocol deviations

Primary outcome: Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.

Time frame: 3-12 months post study treatment. Number. Unit: % of participants

Measure	Standard PVI Ablation n = 179	FIRM-guided Procedure and PVI n = 171
Value	67.5	69.3

Standard PVI Ablation vs FIRM-guided Procedure and PVI: p = 0.7266, Chi-squared

Population analysed: ITT group, defined as each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted

Primary outcome: Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure

Time frame: 3 to 12 months post study treatment. Count of participants. Unit: Participants

Measure	Standard PVI Ablation n = 163	FIRM-guided Procedure and PVI n = 167
Value	146	144

Standard PVI Ablation vs FIRM-guided Procedure and PVI: p = 0.3522, Chi-squared

Population analysed: ITT group, defined as each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard PVI Ablation	19 of 179 (10.6%)	0 of 179 (0%)	1 of 179
FIRM-guided Procedure and PVI	28 of 171 (16.4%)	0 of 171 (0%)	2 of 171

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Persistent Atrial Fibrillation

Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With TRUPULSE™ Generator in Persistent Atrial Fibrillation
Atrial Fibrillation
Not yet recruitingPhase 4
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
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Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation

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.

Johannes Brachmann, MD principal investigator

Klinikum Coburg GmbH

18 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standard PVI Ablation and FIRM-Guided Procedure and PVI in people with Persistent Atrial Fibrillation, run by Abbott Medical Devices at 18 sites in 3 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 3 inclusion and 5 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 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Germany, 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 7 Feb 2020). 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 Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure (time frame: Within 7-10 days of the Procedure). The study lists 4 primary outcomes in all. 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 NCT02274857.

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 Feb 2020.