Persistent Atrial FibrillationCLAAAFNCT01144858
Clinical Value of Left Atrial Appendage Flow for Prediction of Successful Catheter Ablation for Persistent Atrial Fibrillation
An observational study of Persistent Atrial Fibrillation and Catheter Ablation, run by Clinique Pasteur at 1 site in France.
Trial summary
The purpose of this study was to determine whether left atrial appendage flow velocity, as determined using trans esophageal echocardiography (TEE), predicts the outcome after catheter ablation of persistent Atrial fibrillation( pAF). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Catheter Ablation
- What is being tested?
- a complete transesophageal echocardiography
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Dec 2009
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: 40 consecutive patients who underwent first-time radiofrequency catheter ablation for pAF. pAF was defined as continuous AF lasting longer than 1 month, resistant to either electrical or pharmacological cardioversion
Who may be able to join
- First-time radiofrequency catheter ablation for pAF. pAF was defined as continuous AF lasting longer than 1 month, resistant to either electrical or pharmacological cardioversion.
- Informed consent
Who cannot join
- Severe valvular disease requiring surgery
- Valvular prosthesis
- Known severe coronary artery disease
- Atrial and/or ventricular thrombosis
- New York Heart Association functional class III to IV
- Cerebrovascular disease
- Pulmonary embolism
- Latent or manifest hyperthyroidism
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to determine whether left atrial appendage flow velocity, as determined using trans esophageal echocardiography (TEE), predicts the outcome after catheter ablation of persistent Atrial fibrillation( pAF).
Read the detailed description
40 PAF patients underwent 3D mapping and ablation. A stepwise approach including circumferential pulmonary vein (PV) isolation, continuous complex-fractionated electrogram (CFE) ablation and linear ablation was performed by the same operator. The procedural end point was termination of persistent AF by catheter ablation, either by conversion directly to sinus rhythm or to atrial tachycardia. Left atrial appendage (LAA) peak flow velocities were measured with transesophageal echography and averaged within each RR interval of 10 consecutive cardiac cycles.
- Conditions
- Persistent Atrial Fibrillation, Catheter Ablation
- Being tested
- a complete transesophageal echocardiography
- Keywords
- atrial fibrillation, ablation catheter, left atrial appendage peak emptying velocity, tool for predicting successful catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a complete transesophageal echocardiographyOther
All patients were evaluated by a complete transesophageal echocardiography with multiplane probes with a 7-MHz transducer before catheter ablation .LA appendage flow was obtained by placing the pulsed Doppler sample volume at the orifice of the LA appendage, after which peak flow velocities were measured and averaged within each RR interval of 10 consecutive cardiac cycles
| Study group | Role | What they receive |
|---|---|---|
| patients with persistent atrial fibrillation ablation | Not described Receives: Other: a complete transesophageal echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
termination of persistent AF by catheter ablation
Secondary outcomes (1)
Recurrences of AF were therefore determined from holter monitoring at 3 and 6 months or 12 leads ECG in care of symptomatic palpitation with clinical interview.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJan 2009
- Study completionDec 2009
Why it stopped: 40 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Pasteur
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144858
- Sponsor's protocol ID
- past-1001-ryth
- Acronym
- CLAAAF
- Status last verified
- Oct 2008
- First submitted
- 15 Jun 2010
- Last updated
- 16 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Combes S, Jacob S, Combes N, Karam N, Chaumeil A, Guy-Moyat B, Treguer F, Deplagne A, Boveda S, Marijon E, Albenque JP. Predicting favourable outcomes in the setting of radiofrequency catheter ablation of long-standing persistent atrial fibrillation: a pilot study assessing the value of left atrial appendage peak flow velocity. Arch Cardiovasc Dis. 2013 Jan;106(1):36-43. doi: 10.1016/j.acvd.2012.09.002. Epub 2012 Dec 20.
PubMed 23374970
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Left Atrial Appendage Flow for Prediction of Successful Catheter Ablation for Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01144858
- Acronym / sponsor ID
- CLAAAF / past-1001-ryth
- Conditions
- Persistent Atrial Fibrillation, Catheter Ablation
- Keywords
- atrial fibrillation, ablation catheter, left atrial appendage peak emptying velocity, tool for predicting successful catheter ablation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 40 patients
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clinique PasteurUniversity, hospital or other
- Study start
- Jan 2009
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Jun 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.
The purpose of this study was to determine whether left atrial appendage flow velocity, as determined using trans esophageal echocardiography (TEE), predicts the outcome after catheter ablation of persistent Atrial fibrillation( pAF).
Detailed description
40 PAF patients underwent 3D mapping and ablation. A stepwise approach including circumferential pulmonary vein (PV) isolation, continuous complex-fractionated electrogram (CFE) ablation and linear ablation was performed by the same operator. The procedural end point was termination of persistent AF by catheter ablation, either by conversion directly to sinus rhythm or to atrial tachycardia. Left atrial appendage (LAA) peak flow velocities were measured with transesophageal echography and averaged within each RR interval of 10 consecutive cardiac cycles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with persistent atrial fibrillation ablation | – | Other: a complete transesophageal echocardiography |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 40 consecutive patients who underwent first-time radiofrequency catheter ablation for pAF. pAF was defined as continuous AF lasting longer than 1 month, resistant to either electrical or pharmacological cardioversion
Key inclusion criteria (2 listed)
- First-time radiofrequency catheter ablation for pAF. pAF was defined as continuous AF lasting longer than 1 month, resistant to either electrical or pharmacological cardioversion.
- Informed consent
Key exclusion criteria (8 listed)
- Severe valvular disease requiring surgery
- Valvular prosthesis
- Known severe coronary artery disease
- Atrial and/or ventricular thrombosis
- New York Heart Association functional class III to IV
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 |
|---|---|---|
| a complete transesophageal echocardiographyAll patients were evaluated by a complete transesophageal echocardiography with multiplane probes with a 7-MHz transducer before catheter ablation .LA appendage flow was obtained by placing the pulsed Doppler sample volume at the orifice of the LA appendage, after which peak flow velocities were measured and averaged within each RR interval of 10 consecutive cardiac cycles | Other | patients with persistent atrial fibrillation ablation |
Primary outcome
termination of persistent AF by catheter ablation
1 secondary outcome
Recurrences of AF were therefore determined from holter monitoring at 3 and 6 months or 12 leads ECG in care of symptomatic palpitation with clinical interview.
Results and safety
The study was stopped early (reason given: 40 patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2010.
- Derived from this study: PubMed 23374970Combes S, Jacob S, Combes N, Karam N, Chaumeil A, Guy-Moyat B, Treguer F, Deplagne A, Boveda S, Marijon E, Albenque JP. Predicting favourable outcomes in the setting of radiofrequency catheter ablation of long-standing persistent atrial fibrillation: a pilot study assessing the value of left atrial appendage peak flow velocity. Arch Cardiovasc Dis. 2013 Jan;106(1):36-43. doi: 10.1016/j.acvd.2012.09.002. Epub 2012 Dec 20.
Related trials for Persistent Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent 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
Atrial Fibrillation (Persistent), Catheter Ablation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Recruiting
Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation
Persistent 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Persistent Atrial Fibrillation and Catheter Ablation, 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 2 inclusion and 8 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 16 Jun 2010. 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?
The study was stopped early (reason given: 40 patients). Results are not available in the source record.
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?
termination of persistent AF by catheter ablation. 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 NCT01144858, 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 16 Jun 2010; AzTrials last refreshed its copy on 7 Nov 2026.