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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01144858
Other study ID # past-1001-ryth
Secondary ID
Status Terminated
Phase N/A
First received June 15, 2010
Last updated June 15, 2010
Start date January 2009
Est. completion date December 2009

Study information

Verified date October 2008
Source Clinique Pasteur
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Observational

Clinical 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).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date December 2009
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Other:
a complete transesophageal echocardiography
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

Locations

Country Name City State
France Clinique Pasteur Toulouse 43-45 avenue de Lombez

Sponsors (1)

Lead Sponsor Collaborator
Clinique Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary termination of persistent AF by catheter ablation Yes
Secondary 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. Yes
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