Atrial FibrillationPhase 4CLARITY-AFNCT01116557

Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)

A Phase 4 study testing Radiofrequency Ablation procedure 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 purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the treatment of paroxysmal atrial fibrillation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Radiofrequency Ablation procedure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: No sites listed yet
Study dates: Apr 2010to Dec 2011
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with PAF who have had two (2) symptomatic PAF episodes in the six (6) months prior to randomization, and who are selected for catheter ablation for the treatment of their AF. Additionally patients with recurrent AF with episodes up to 30 days with sinus rhythm maintained for more than one week following cardioversion and who require PVI only for the treatment of their AF (supported by the consensus statement2). At least one AF episode should be documented either on ECG, TTM, HM or telemetry strip.
Failure of at least one AAD for PAF [class I or III] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to the AAD.
Signed Patient Informed Consent Form.
Age 18 years or older.
Able and willing to comply with all pre- and follow-up testing and requirements.

Who cannot join

Longstanding persistent atrial fibrillation
Patients with a history of any atrial flutter requiring ablation in the right atrium during the study procedure
Patients in whom sinus rhythm was maintained for less than 1 week after electrical cardioversion
Previous ablation for AF
LA size > 55 mm
LVEF < 40% (ejection fraction)

Show all 21Show fewer

AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
CABG procedure within the last six (6) months
Awaiting cardiac transplantation or other cardiac surgery
Documented left atrial thrombus on imaging (eg, TEE)
Diagnosed atrial myxoma
Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable) or breastfeeding
Acute illness or active systemic infection or sepsis
Unstable angina
Uncontrolled heart failure
Myocardial infarction within the previous two (2) months
History of blood clotting or bleeding abnormalities
Contraindication to anticoagulation therapy (ie. heparin or warfarin)
Life expectancy less than 12 months
Enrollment in any other study evaluating another device or drug
Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation

About this study

Official title: CARTO® 3 System-guided RF Ablation Using the THERMOCOOL® Catheter Versus Fluoroscopy-guided RF Ablation Using the Pulmonary Vein Ablation Catheter® (PVAC®) in Subjects With Paroxysmal Atrial Fibrillation: A Prospective, Multi-center, Randomized (2:1), Controlled, Two-arm, Unblinded Clinical Study

Read the detailed description

This study is a prospective, multi-center, randomized (2:1), controlled, two-arm, unblinded, clinical study, which will evaluate the efficacy, safety, and efficiency of CARTO® 3 System-guided RF ablation (using the THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter) compared to fluoroscopy-guided RF ablation (using the PVAC®). Patients with symptomatic PAF who meet the inclusion criteria will be considered for study participation and may be enrolled if no exclusion criteria apply.

Eligible subjects who signed the study informed consent form will be randomized into one of two treatment groups:

THERMOCOOL® Group: RF ablation to achieve PVI using the CARTO® 3 System, THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter
PVAC® Group: RF ablation to achieve PVI using fluoroscopy and the PVAC®

Conditions: Atrial Fibrillation
Being tested: Radiofrequency Ablation procedure
Keywords: radiofrequency, ablation, atrial fibrillation, CARTO, THERMOCOOL, LASSO, PVAC
Medical subject headings: Atrial Fibrillation

What participants receive

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

Radiofrequency Ablation procedureDevice
Also called CARTO®3 System, LASSO® Circular Mapping Catheter, THERMOCOOL® Catheter
Radiofrequency Ablation procedure Application of radiofrequency energy with the THERMOCOOL® catheter used in combination with the CARTO® 3 System and the LASSO® Circular Mapping Catheter to eliminate potentials arising from the pulmonary veins.
Radiofrequency Ablation procedureDevice
Also called PVAC®
Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins.

Study groups in NCT01116557
Study group	Role	What they receive
THERMOCOOL® group	Other	Radiofrequency ablation to achieve PVI using the CARTO® 3 System, the THERMOCOOL® Catheter and the LASSO® Circular Mapping Catheter. Receives: Device: Radiofrequency Ablation procedure
PVAC® group	Active comparator	Radiofrequency ablation to achieve PVI using fluoroscopy and the PVAC® Receives: Device: Radiofrequency Ablation procedure

What is being measured

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

Freedom from documented AF/AT recurrences without new AADs
Subjects will be considered a success for the primary efficacy endpoint if the subject is free from documented recurrences of AF or AT lasting more than 30s as measured with Transtelephonic Monitoring and Standard of Care arrhythmia monitoring during a 3-12 month follow-up period post-ablation.
Measured: 1 year follow-up post-ablation
Incidence of PV Stenosis (number of PVs with a reduction in diameter ≥ 50% at 6 months compared to baseline per CT or MRI)
Measured: at 6 months post-ablation
Total procedure time
Measured: at the time of the initial ablation procedure

Secondary outcomes (19)

Acute procedural success
Measured by the number (%) of subjects with confirmed entrance block at the end of the ablation procedure
Measured: at the time of the initial ablation procedure
Repeat ablation procedures for AF/AT recurrences
Measured by % of subjects undergoing repeat ablation procedures for Recurring AF/AT
Measured: through 3-12 month follow-up period post-ablation
Freedom from documented AF/AT recurrences without AAD(s)
Measured by % achieving freedom from documented AF/AT recurrences
Measured: through 3-12 month follow-up period post-ablation
Freedom from documented AF/AT recurrences with AAD(s)
Measured by % achieving freedom from documented AF/AT recurrences
Measured: through 3-12 month follow-up period post-ablation
Freedom from documented AF/AT recurrences after more than one ablation procedure
Measured by % achieving freedom from documented AF/AT recurrences
Measured: through 3-12 month follow-up period post-ablation
Freedom from documented AF recurrences without AADs
Measured by % achieving freedom from documented AF/AT recurrences
Measured: through 3-12 month follow-up period post-ablation
Freedom from documented AF recurrences with AAD(s)
Measured by % achieving freedom from documented AF/AT recurrences
Measured: through 3-12 month follow-up period post-ablation
Freedom from documented symptomatic AF/AT recurrences without new AAD(s)
Measured by % achieving freedom from documented symptomatic AF/AT recurrences
Measured: through 3-12 month follow-up period post-ablation
Freedom from documented symptomatic AF/AT recurrences with AAD(s)
Measured: through 3-12 month follow-up period post-ablation
Incidence of any procedure-related and/or device-related adverse events occurring during the study
Measured: through 1 year follow-up
Incidence of any catheter-related adverse events
Measured: during 7 days follow-up post-ablation
Total Fluoroscopy exposure time
Measured by fluoroscopy and cine-fluoroscopy time throughout procedure
Measured: at the time of the ablation procedure
Total Fluoroscopy Dose-Area Product/Source Intensifier Distance
Measured: at the time of the ablation procedure
Incidence of any phrenic nerve paralysis
Measured: through 1 year follow-up post-ablation
Incidence of any symptomatic Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA)
Measured: through 1 year follow-up post-ablation
Number of mapping and ablation catheters used per subject
Measured: through 1 year follow-up post-ablation
Quality of Life (SF-36®) and Atrial Fibrillation Symptom Frequency and Severity Checklist assessment
Measured: Baseline, 3, 6 and 12 months
Total procedure hospital visit and ablation procedure costs
Measured: during hospitalization stay for study treatment
Total number of initial or prolonged hospitalizations and unscheduled arrhythmia-related health care provider visits (including emergency department visits)
Measured: through 1 year follow-up post-ablation

Timeline

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

Apr 2010Dec 2011

First posted5 May 2010 (estimated)
Study startApr 2010
Primary completionDec 2011
Study completionDec 2011

Why it stopped: Biosense stopped Study enrollment following publications that reported PVAC ablation is linked with a higher incidence of asymptomatic cerebral embolic lesions

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Biosense Webster, Inc.The 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01116557
Sponsor's protocol ID: BWI130
Acronym: CLARITY-AF
Status last verified: Jan 2025
First submitted: 3 May 2010
Last updated: 3 Feb 2025
Results posted: No
Data monitoring committee: 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

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)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CARTO® 3 System-guided RF Ablation Using the THERMOCOOL® Catheter Versus Fluoroscopy-guided RF Ablation Using the Pulmonary Vein Ablation Catheter® (PVAC®) in Subjects With Paroxysmal Atrial Fibrillation: A Prospective, Multi-center, Randomized (2:1), Controlled, Two-arm, Unblinded Clinical Study
ClinicalTrials.gov ID: NCT01116557
Acronym / sponsor ID: CLARITY-AF / BWI130
Conditions: Atrial Fibrillation
Keywords: radiofrequency, ablation, atrial fibrillation, CARTO, THERMOCOOL, LASSO, PVAC
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Biosense stopped Study enrollment following publications that reported PVAC ablation is linked with a higher incidence of asymptomatic cerebral embolic lesions
Enrolment: 79 participants (actual)
Lead sponsor: Biosense Webster, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 5 May 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.

Detailed description

Eligible subjects who signed the study informed consent form will be randomized into one of two treatment groups:

THERMOCOOL® Group: RF ablation to achieve PVI using the CARTO® 3 System, THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter
PVAC® Group: RF ablation to achieve PVI using fluoroscopy and the PVAC®

Study design

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

Arm	Type	Receives
THERMOCOOL® group	Other	Device: Radiofrequency Ablation procedureRadiofrequency ablation to achieve PVI using the CARTO® 3 System, the THERMOCOOL® Catheter and the LASSO® Circular Mapping Catheter.
PVAC® group	Active comparator	Device: Radiofrequency Ablation procedureRadiofrequency ablation to achieve PVI using fluoroscopy and the PVAC®

Who may qualify

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

Key inclusion criteria (5 listed)

Patients with PAF who have had two (2) symptomatic PAF episodes in the six (6) months prior to randomization, and who are selected for catheter ablation for the treatment of their AF. Additionally patients with recurrent AF with episodes up to 30 days with sinus rhythm maintained for more than one week following cardioversion and who require PVI only for the treatment of their AF (supported by the consensus statement2). At least one AF episode should be documented either on ECG, TTM, HM or telemetry strip.
Failure of at least one AAD for PAF [class I or III] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to the AAD.
Signed Patient Informed Consent Form.
Age 18 years or older.
Able and willing to comply with all pre- and follow-up testing and requirements.

Key exclusion criteria (21 listed)

Longstanding persistent atrial fibrillation
Patients with a history of any atrial flutter requiring ablation in the right atrium during the study procedure
Patients in whom sinus rhythm was maintained for less than 1 week after electrical cardioversion
Previous ablation for AF
LA size > 55 mm

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
Radiofrequency Ablation procedureAlso: CARTO®3 System, LASSO® Circular Mapping Catheter, THERMOCOOL® CatheterRadiofrequency Ablation procedure Application of radiofrequency energy with the THERMOCOOL® catheter used in combination with the CARTO® 3 System and the LASSO® Circular Mapping Catheter to eliminate potentials arising from the pulmonary veins.	Device	THERMOCOOL® group
Radiofrequency Ablation procedureAlso: PVAC®Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins.	Device	PVAC® group

Primary outcome

Freedom from documented AF/AT recurrences without new AADs
Time frame: 1 year follow-up post-ablation
Subjects will be considered a success for the primary efficacy endpoint if the subject is free from documented recurrences of AF or AT lasting more than 30s as measured with Transtelephonic Monitoring and Standard of Care arrhythmia monitoring during a 3-12 month follow-up period post-ablation.
Incidence of PV Stenosis (number of PVs with a reduction in diameter ≥ 50% at 6 months compared to baseline per CT or MRI)
Time frame: at 6 months post-ablation
Total procedure time
Time frame: at the time of the initial ablation procedure

19 secondary outcomes

Acute procedural success
Time frame: at the time of the initial ablation procedure
Repeat ablation procedures for AF/AT recurrences
Time frame: through 3-12 month follow-up period post-ablation
Freedom from documented AF/AT recurrences without AAD(s)
Time frame: through 3-12 month follow-up period post-ablation
Freedom from documented AF/AT recurrences with AAD(s)
Time frame: through 3-12 month follow-up period post-ablation
Freedom from documented AF/AT recurrences after more than one ablation procedure
Time frame: through 3-12 month follow-up period post-ablation
Freedom from documented AF recurrences without AADs
Time frame: through 3-12 month follow-up period post-ablation
Freedom from documented AF recurrences with AAD(s)
Time frame: through 3-12 month follow-up period post-ablation
Freedom from documented symptomatic AF/AT recurrences without new AAD(s)
Time frame: through 3-12 month follow-up period post-ablation
Freedom from documented symptomatic AF/AT recurrences with AAD(s)
Time frame: through 3-12 month follow-up period post-ablation
Incidence of any procedure-related and/or device-related adverse events occurring during the study
Time frame: through 1 year follow-up
Incidence of any catheter-related adverse events
Time frame: during 7 days follow-up post-ablation
Total Fluoroscopy exposure time
Time frame: at the time of the ablation procedure
Total Fluoroscopy Dose-Area Product/Source Intensifier Distance
Time frame: at the time of the ablation procedure
Incidence of any phrenic nerve paralysis
Time frame: through 1 year follow-up post-ablation
Incidence of any symptomatic Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA)
Time frame: through 1 year follow-up post-ablation
Number of mapping and ablation catheters used per subject
Time frame: through 1 year follow-up post-ablation
Quality of Life (SF-36®) and Atrial Fibrillation Symptom Frequency and Severity Checklist assessment
Time frame: Baseline, 3, 6 and 12 months
Total procedure hospital visit and ablation procedure costs
Time frame: during hospitalization stay for study treatment
Total number of initial or prolonged hospitalizations and unscheduled arrhythmia-related health care provider visits (including emergency department visits)
Time frame: through 1 year follow-up post-ablation

Results and safety

The study was stopped early (reason given: Biosense stopped Study enrollment following publications that reported PVAC ablation is linked with a higher incidence of asymptomatic cerebral embolic lesions). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.

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.

Mattias Duytschaever, MD principal investigator

A.Z. St Jan AV

Yves De Greef, MD principal investigator

A.Z. Middelheim

Stuart Harris, MD principal investigator

Essex Cardiothoracic Centre

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Radiofrequency Ablation procedure 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 5 inclusion and 21 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 3 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?

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 documented AF/AT recurrences without new AADs (time frame: 1 year follow-up post-ablation). 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?

On the ClinicalTrials.gov record for NCT01116557.

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 3 Feb 2025.