- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01144858
Clinical Value of Left Atrial Appendage Flow for Prediction of Successful Catheter Ablation for Persistent Atrial Fibrillation (CLAAAF)
June 15, 2010 updated by: Clinique Pasteur
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
43-45 avenue de Lombez
-
Toulouse, 43-45 avenue de Lombez, France, 31076
- Clinique Pasteur
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients with persistent atrial fibrillation ablation
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
termination of persistent AF by catheter ablation
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
June 15, 2010
First Submitted That Met QC Criteria
June 15, 2010
First Posted (Estimate)
June 16, 2010
Study Record Updates
Last Update Posted (Estimate)
June 16, 2010
Last Update Submitted That Met QC Criteria
June 15, 2010
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- past-1001-ryth
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.