Atrial FibrillationPhase 4ATTESTNCT01570361

Atrial Fibrillation Progression Trial

A Phase 4 study testing Catheter Ablation and Drug Treatment in people with Atrial Fibrillation, run by Biosense Webster, Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation (PAF), delays progression of atrial… Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Catheter Ablation and Drug Treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 255 participants
Where: No sites listed yet
Study dates: 13 Feb 2012to 19 Dec 2018
Phase: Phase 4
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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with recurrent paroxysmal atrial fibrillation (AF) for at least 2 years, with ≥ 2 episodes over the last 6 months; (per Amendment v3, 09APR2013, previous "6 episodes" )
HATCH Score of at least ≥1 and ≤4.
Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).
Age 60 years or older.
Left atrium (LA) diameter ≤ 55mm by TTE.
Left ventricle (LV) ejection fraction ≥50% when in sinus rhythm or LV ejection fraction ≥35% when in atrial fibrillation.
NOTE: For patients entering the study in AF with an ejection fraction ≥35% and <50%; the ejection fraction should be re-checked when in sinus rhythm. In case the ejection fraction is >50% the subject can continue in the study.
Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow-up testing.

Who cannot join

Patients awaiting cardiac transplantation or other cardiac surgery.
Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant of the study.
Reversible causes of atrial fibrillation, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma, etc.
Recent cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), or valve or bypass surgery in the preceding 3 months.
Heart failure decompensation.
Previously diagnosed with persistent/permanent atrial fibrillation/ atrial flutter.

Show all 23Show fewer

Previously required cardioversion >48 hours after onset of atrial fibrillation/ atrial flutter.
Subject having previous transischemic attack (TIA) or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no sufficient recovery.
Pulmonary embolism or recent atrial embolism/thrombosis.
Hypertrophic obstructive cardiomyopathy.
Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation).
Mandated anti-arrhythmic drug therapy for disease conditions other than atrial fibrillation.
Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs.
Prior left atrial catheter ablation with the intention of treating atrial fibrillation; prior surgical interventions for AF such as the MAZE procedure.
Prior AV nodal ablation.
Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use.
Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications.
Medical conditions limiting expected survival to <3 years.
Concurrent participation in any other clinical study.
Prior history of non-adherence to prescribed drug regimens.
Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial
NOTE: Prior ablation of the cavo-tricuspid isthmus is not a reason to exclude, if the patient develops subsequent recurrent atrial fibrillation.
NOTE: For patients randomized to the PVI group (Test Group), a Transesophageal Echocardiography (TEE) should be performed (as per standard of care), within 48 hours pre-procedure, to exclude atrial thrombus or other structural contraindications for an ablation procedure.

About this study

Read the detailed description

Eligible PAF subjects with recurrent AF for 2 years who have failed no more than 2 prescribed drugs (with either anti-arrhythmic or rate control drug) are randomized into one of two study arms (catheter ablation or drug therapy).

Conditions: Atrial Fibrillation
Being tested: Catheter Ablation, Drug Treatment
Keywords: Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes
Medical subject headings: Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Catheter AblationDevice
Also called CARTO® 3 or CARTO® XP System and THERMOCOOL® Catheter Family
Treat subjects with Paroxysmal Atrial Fibrillation (PAF)
Drug TreatmentDrug
Also called Antiarrhythmic Drugs
Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.

Study groups in NCT01570361
Study group	Role	What they receive
Catheter Ablation	Experimental	Radiofrequency catheter ablation treatment in subjects with Paroxysmal Atrial Fibrillation (PAF) Receives: Device: Catheter Ablation
Drug Treatment	Active comparator	Drug therapy (either rate or rhythm control) using current AF management guidelines Receives: Drug: Drug Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years
Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Measured: 3 years

Secondary outcomes (10)

Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Measured: 1 year
Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years
Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Measured: 2 years
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 1 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Measured: 1 year
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years
Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 2 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Measured: 2 Years
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year
Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Measured: 3 year
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations
Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year by number of repeat ablations were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Measured: 3 years
Number of Repeat Ablations
Number of repeat ablations refers to the total number of ablation procedures (including initial ablation procedure). If the number of repeat ablations =1 then subject only had one ablation procedure (initial ablation procedure in test group as randomized or cross-over procedure in cross-over subjects). If the number of repeat ablations is >= 2, then subject had at least one repeat procedure.
Measured: 3 years
Number of New Antiarrhythmic Drugs
Number of new antiarrhythmic drugs were administered as per investigator's discretion and 2006 AF management guidelines.
Measured: 3 years
Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up
Subject in sinus rhythm: no other rhythms documented at specific visit, based on ECG, Holter and event recorder. Percentages are calculated with respect to number of subjects with data available at corresponding visit
Measured: 3 months, 6 months, 1 year, 2 years, 3 years
Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up
Subjects with recurrent AF/AT: any AF/AT documented between previous visit up to visit analyzed at any TTM, Holter or ECG. Percentages are calculated with respect to number of subjects with data available at corresponding visit
Measured: 3 months, 6 months, 1 year, 2 year and 3 years

Timeline

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

13 Feb 201219 Dec 2018

First posted4 Apr 2012 (estimated)
Study start13 Feb 2012
Primary completion19 Dec 2018
Study completion19 Dec 2018

Why it stopped: The sponsor decided to terminate the study early due to enrolment not proceeding in accordance with expectations, independently from the study outcome.

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 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 255 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01570361
Sponsor's protocol ID: ATTEST
Acronym: ATTEST
Status last verified: Jan 2025
First submitted: 28 Mar 2012
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated device: Yes

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?

Official record

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All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Atrial Fibrillation Progression Trial
ClinicalTrials.gov ID: NCT01570361
Acronym / sponsor ID: ATTEST / ATTEST
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The sponsor decided to terminate the study early due to enrolment not proceeding in accordance with expectations, independently from the study outcome.
Enrolment: 255 participants (actual)
Lead sponsor: Biosense Webster, Inc.Industry (pharma, biotech, devices)
Study start: 13 Feb 2012 (actual)
Primary completion: 19 Dec 2018 (actual)
Study completion: 19 Dec 2018 (actual)
First posted: 4 Apr 2012 (estimated)
Results: Posted 14 May 2020

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Catheter Ablation	Experimental	Device: Catheter AblationRadiofrequency catheter ablation treatment in subjects with Paroxysmal Atrial Fibrillation (PAF)
Drug Treatment	Active comparator	Drug: Drug TreatmentDrug therapy (either rate or rhythm control) using current AF management guidelines

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients with recurrent paroxysmal atrial fibrillation (AF) for at least 2 years, with ≥ 2 episodes over the last 6 months; (per Amendment v3, 09APR2013, previous "6 episodes" )
HATCH Score of at least ≥1 and ≤4.
Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).
Age 60 years or older.
Left atrium (LA) diameter ≤ 55mm by TTE.

Key exclusion criteria (23 listed)

Patients awaiting cardiac transplantation or other cardiac surgery.
Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant of the study.
Reversible causes of atrial fibrillation, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma, etc.
Recent cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), or valve or bypass surgery in the preceding 3 months.
Heart failure decompensation.

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 AblationAlso: CARTO® 3 or CARTO® XP System and THERMOCOOL® Catheter FamilyTreat subjects with Paroxysmal Atrial Fibrillation (PAF)	Device	Catheter Ablation
Drug TreatmentAlso: Antiarrhythmic DrugsDrug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.	Drug	Drug Treatment

Primary outcome

Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years
Time frame: 3 years
Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.

10 secondary outcomes

Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
Time frame: 1 year
Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years
Time frame: 2 years
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
Time frame: 1 year
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years
Time frame: 2 Years
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year
Time frame: 3 year
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations
Time frame: 3 years
Number of Repeat Ablations
Time frame: 3 years
Number of New Antiarrhythmic Drugs
Time frame: 3 years
Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up
Time frame: 3 months, 6 months, 1 year, 2 years, 3 years
Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up
Time frame: 3 months, 6 months, 1 year, 2 year and 3 years

Results and safety

Results posted to the registry on 14 May 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
Radiofrequency (RF) Ablation Treatment	128	46
Antiarrhythmic Drug (AAD) Therapy	127	52

Primary outcome: Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years

Time frame: 3 years. Median (95% Confidence Interval). Unit: Months

Measure	Radiofrequency (RF) Ablation Treatment n = 128	Antiarrhythmic Drug (AAD) Therapy n = 127
Value	NA (NA to NA)	NA (NA to NA)

Radiofrequency (RF) Ablation Treatment vs Antiarrhythmic Drug (AAD) Therapy: p = 0.0009, Log Rank

Population analysed: Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 years follow up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Radiofrequency (RF) Ablation Treatment	38 of 102 (37.3%)	37 of 102 (36.3%)	5 of 102
Antiarrhythmic Drug (AAD) Therapy Only	30 of 108 (27.8%)	43 of 108 (39.8%)	4 of 108
Antiarrhythmic Drug (AAD) Therapy - First Treatment	7 of 15 (46.7%)	6 of 15 (40%)	0 of 15
Radiofrequency (RF) Ablation - Second Treatment	4 of 15 (26.7%)	4 of 15 (26.7%)	0 of 15

Limitations and caveats (from the sponsor): As the study was terminated early without having met primary effectiveness or futility criteria, the study results should be interpreted with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Karl-Heinz Kuck, MD principal investigator

Asklepios Klinik St. Georg

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Catheter Ablation and Drug Treatment in people with Atrial Fibrillation, run by Biosense Webster, Inc..

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 8 inclusion and 23 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 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?

Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years (time frame: 3 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 NCT01570361.

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 4 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.