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Atrial Fibrillation Ablation The Hybrid Approach Versus Traditional Management

Feb 18, 2011 No Comments by

Rationale: To determine the most beneficial ablation methodology for individual patients
with paroxysmal or persistent atrial fibrillation (defined by the Heart Rhythm Society) as
surgeons and electrophysiologists work together on a convergent procedure (hybrid) to place
the epicardial and endocardial ablation lines.

Objectives: Catheter and surgical ablation are being offered today to patients with drug
refractory and symptomatic atrial fibrillation. This study is designed to assess the most
efficient ablation approach in patients with paroxysmal and persistent atrial fibrillation.
In patients with left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein
isolation performed surgically will be combined with right and left atrial flutter lines
performed using a transcatheter approach) will be compared to percutaneous catheter ablation
to isolate the pulmonary veins and apply the left and right atrial flutter lines with
removal of LA appendage. In the group of patients with left atrial size 5.0-6.0 cm the
Hybrid approach is going to be compared to the minimally invasive Cox-Maze III procedure.

Our hypotheses with regard to the rate of return to sinus rhythm off antiarrhythmic drugs at
6 months will demonstrate that the Hybrid approach is going to be a: superior to
percutaneous catheter ablation in the less than 5 cm left atrial group and b: non-inferior
when compared to the Cox-Maze III procedure in the 5-6 cm left atrial cm group.

We hypothesize that the safety of all procedures will show no differences and that there
will be no differences in clinical complications between groups.

Clinical Trial Conditions: Ablation of Atrial Fibrillation

Treatments in this Clinical Trial : Pulmonary vein isolation ablation procedure for atrial fibrillation, Hybrid procedure for ablation of atrial fibrillation, The Cox Maze Procedure for Ablation of Atrial Fibrillation, Hybrid Procedure for Left Atrium >5 cm but < 6.1 cm

Eligible Clinical Trial Participant Age : Between 18 years to 100 years

Can Healthy Volunteers Participate: No

Clinical Trial Lead Sponsor: Inova Health Care Services

Detailed Clinical Trial Description: Rationale: To determine the most beneficial ablation methodology for individual patients
with paroxysmal or persistent atrial fibrillation (defined by the Heart Rhythm Society) as
surgeons and electrophysiologists work together on a convergent procedure (hybrid) to place
the epicardial and endocardial ablation lines.

Objectives: Catheter and surgical ablation are being offered today to patients with drug
refractory and symptomatic atrial fibrillation. This study is designed to assess the most
efficient ablation approach in patients with paroxysmal and persistent atrial fibrillation.
In patients with left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein
isolation performed surgically will be combined with right and left atrial flutter lines
performed using a transcatheter approach) will be compared to percutaneous catheter ablation
to isolate the pulmonary veins and apply the left and right atrial flutter lines with
removal of LA appendage. In the group of patients with left atrial size 5.0-6.0 cm the
Hybrid approach is going to be compared to the minimally invasive Cox-Maze III procedure.

Our hypotheses with regard to the rate of return to sinus rhythm off antiarrhythmic drugs at
6 months will demonstrate that the Hybrid approach is going to be a: superior to
percutaneous catheter ablation in the less than 5 cm left atrial group and b: non-inferior
when compared to the Cox-Maze III procedure in the 5-6 cm left atrial cm group.

We hypothesize that the safety of all procedures will show no differences and that there
will be no differences in clinical complications between groups.

The clinical trial information was obtained from http://clinicaltrials.gov/ct2/show/NCT01298986

New Clinical Trial

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By: ifood.tv