Cryoablation of AF: Improving the Use of the Achieve Catheter

An observational study of Atrial Fibrillation, run by Clinique Pasteur at 1 site in France.

Completed

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

Trial summary

According to data from high volume Centres, documentation of entry block with the Achieve catheter may be possible in only about to 50% of pulmonary veins. The investigators aim to assess strategies using the Achieve catheter that can improve this performance. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Atrial Fibrillation
What is being tested?: Maneuvers for documenting the disconnection
How many people: 34 participants
Where: 1 siteFrance
Study dates: Apr 2013to Aug 2013
Phase: Observational
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 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Consecutive patients undergoing cryoablation of atrial fibrillation using the Achieve catheter to document pulmonary vein disconnection.

Who may be able to join

all consecutive patients undergoing atrial fibrillation cryoballoon ablation monitored with the Achieve catheter.

Who cannot join

patients in AF at the beginning of the procedure
patients with a previous AF ablation procedure

Trial locations and contacts

1 site in 1 country.

France1 site

Clinique Pasteur
Toulouse, Haute-Garonne, 31000

Other trials in France

About this study

Official title: Improving the Assessment of Pulmonary Vein Disconnection With the Achieve Catheter During Atrial Fibrillation Cryoablation

Conditions: Atrial Fibrillation
Being tested: Maneuvers for documenting the disconnection
Keywords: atrial fibrillation, balloon cryoablation, pulmonary veins
Medical subject headings: Atrial Fibrillation

What participants receive

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

Maneuvers for documenting the disconnectionOther
Also called type 1, type 2, type 3, type 4

Study groups in NCT01843465
Study group	Role	What they receive
Cryoablation of atrial fibrillation		Not described Receives: Other: Maneuvers for documenting the disconnection

What is being measured

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

Real-time Documentation of Pulmonary Vein Disconnection
Possibility of real-time documentation of the pulmonary vein during cryoballoon ablation, through the use of the Achieve catheter. This will be codified as "yes" or "no", and in case of an affirmative answer Final results will be expressed as a % of the total pulmonary veins where disconnection was documented in real-time and the time of maneuver of the Achieve catheter that was necessary i.e. standard position (type 1); withdrawal position (type 2) or need of pacing (type 3). A pulmonary vein where no real-time documentation is possible, will be named as a type 4.
Measured: atrial fibrillation cryoablation procedure

Timeline

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

Apr 2013Aug 2013

First posted30 Apr 2013 (estimated)
Study startApr 2013
Primary completionJul 2013
Study completionAug 2013

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.
Publications (1)Papers the sponsor has linked to this study.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01843465
Sponsor's protocol ID: CP-CRYO-001
Status last verified: Oct 2013
First submitted: 26 Apr 2013
Last updated: 13 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Boveda S, Providencia R, Albenque JP, Combes N, Combes S, Hireche H, Casteigt B, Bouzeman A, Jourda F, Narayanan K, Marijon E. Real-time assessment of pulmonary vein disconnection during cryoablation of atrial fibrillation: can it be 'achieved' in almost all cases? Europace. 2014 Jun;16(6):826-33. doi: 10.1093/europace/eut366. Epub 2013 Dec 18.
PubMed 24351882

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

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 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving the Assessment of Pulmonary Vein Disconnection With the Achieve Catheter During Atrial Fibrillation Cryoablation
ClinicalTrials.gov ID: NCT01843465
Acronym / sponsor ID: CP-CRYO-001
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation, balloon cryoablation, pulmonary veins
Study type: Observational
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Clinique PasteurUniversity, hospital or other
Study start: Apr 2013
Primary completion: Jul 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 30 Apr 2013 (estimated)
Results: Posted 13 Dec 2013

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cryoablation of atrial fibrillation	–	Other: Maneuvers for documenting the disconnection

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Consecutive patients undergoing cryoablation of atrial fibrillation using the Achieve catheter to document pulmonary vein disconnection.

Key inclusion criteria (1 listed)

all consecutive patients undergoing atrial fibrillation cryoballoon ablation monitored with the Achieve catheter.

Key exclusion criteria (2 listed)

patients in AF at the beginning of the procedure
patients with a previous AF ablation procedure

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
Maneuvers for documenting the disconnectionAlso: type 1, type 2, type 3, type 4	Other	Cryoablation of atrial fibrillation

Primary outcome

Real-time Documentation of Pulmonary Vein Disconnection
Time frame: atrial fibrillation cryoablation procedure
Possibility of real-time documentation of the pulmonary vein during cryoballoon ablation, through the use of the Achieve catheter. This will be codified as "yes" or "no", and in case of an affirmative answer Final results will be expressed as a % of the total pulmonary veins where disconnection was documented in real-time and the time of maneuver of the Achieve catheter that was necessary i.e. standard position (type 1); withdrawal position (type 2) or need of pacing (type 3). A pulmonary vein where no real-time documentation is possible, will be named as a type 4.

Results and safety

Results posted to the registry on 13 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cryoablation of Atrial Fibrillation	34	34

Primary outcome: Real-time Documentation of Pulmonary Vein Disconnection

Time frame: atrial fibrillation cryoablation procedure. Number. Unit: number of PVs disconnected in realtime

Measure	Cryoablation of Atrial Fibrillation n = 34
Value	125

Population analysed: According to the different pulmonary vein anatomies in the study sample, 128 pulmonary veins were assessed.

Adverse events

Other adverse events reported at 2.9% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cryoablation of Atrial Fibrillation	0 of 34 (0%)	2 of 34 (5.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24351882Boveda S, Providencia R, Albenque JP, Combes N, Combes S, Hireche H, Casteigt B, Bouzeman A, Jourda F, Narayanan K, Marijon E. Real-time assessment of pulmonary vein disconnection during cryoablation of atrial fibrillation: can it be 'achieved' in almost all cases? Europace. 2014 Jun;16(6):826-33. doi: 10.1093/europace/eut366. Epub 2013 Dec 18.

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.

Serge Boveda, M.D. principal investigator

Clinique Pasteur

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Clinique Pasteur at 1 site in France.

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 1 inclusion and 2 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 13 Dec 2013. 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 France. 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 13 Dec 2013). 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?

Real-time Documentation of Pulmonary Vein Disconnection (time frame: atrial fibrillation cryoablation procedure). 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 NCT01843465, which also lists 1 linked publication.

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 13 Dec 2013.