Atrial Fibrillation Ablation The Hybrid Approach Versus Traditional Management - Full Text View

Sponsor:	Inova Health Care Services
Information provided by (Responsible Party):	Linda Henry, Inova Health Care Services
ClinicalTrials.gov Identifier:	NCT01298986

Purpose

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.

Condition	Intervention	Phase
Ablation of Atrial Fibrillation	Procedure: Pulmonary vein isolation ablation procedure for atrial fibrillation Procedure: Hybrid procedure for ablation of atrial fibrillation Procedure: The Cox Maze Procedure for Ablation of Atrial Fibrillation Procedure: Hybrid Procedure for Left Atrium >5 cm but < 6.1 cm	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Atrial Fibrillation Ablation The Hybrid Approach Versus Traditional Management

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Inova Health Care Services:

Primary Outcome Measures:

Return to sinus rhythm rate [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
The primary outcome will be the rate of return to sinus rhythm as defined by the Heart Rhythm Society Guidelines (sinus rhythm maintained off anti arrhythmic medications and any monitored atrial arrhythmia greater than 30 seconds will be considered a recurrence) at 6 months.

Secondary Outcome Measures:

Post procedure morbidities [ Time Frame: up to 6 months post procedure ] [ Designated as safety issue: Yes ]
The secondary outcomes will include:

Total AF burden Number and type of procedural complications Number of embolic strokes The number of major bleeding as defined by the need to receive a transfusion for the amount of blood lost and or hemorrhagic stroke while receiving anticoagulation therapy.

Reported improvement in patients' self reported health related quality of life and their symptom frequency and severity at 3 and 6 months

Estimated Enrollment:	152
Study Start Date:	May 2011
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Pulmonary Vein Isolation Patients who have paroxysmal or persistent atrial fibrillation but whose left atrium is < /= 5.0	Procedure: Pulmonary vein isolation ablation procedure for atrial fibrillation The catheters will be introduced to the right atrium using the femoral vein as an access. Following a trans-septal puncture, ablation catheters will be placed in the left atrium under appropriate imaging and anticoagulation conditions (Standard of care). Following the positioning of the ablation catheters in the left heart cavity ablation to achieve PVI and left atrial isthmus line are going to be performed. Following the appropriate protocol of mapping and AF induction the right sided isthmus is going to be ablated to achieve a flutter line ablation as well. Following the procedure and following the appropriate standard of care protocols, the catheter are going to be retrieved and the procedure will be concluded. The left atrial appendage will be managed surgically. All ablation lines will be placed according to their current standard of practice using radiofrequency ablation technology and based on CARTO mapping.
Experimental: Hybrid procedure for patients with a left atrium < /= 5.0 cm A combined procedure where the cardiac surgeon will place the ablation lesions on top of the heart and the electrophysiologist will place the lesions inside the heart. 3D mapping with be used to guide the procedure. The left atrial appendage will be surgically managed.	Procedure: Hybrid procedure for ablation of atrial fibrillation The endoscope will be passed though a small port in the right thoracic cavity to the beating heart. The pericardium will be opened, the coronary sinus transected. The ablation catheters will pass underneath the SVC and IVC establishing access to the transverse and oblique sinuses. A box lesion will be epicardially placed around the pulmonary veins using cryothermia. An additional lesion line will be placed from the box lesion to the left atrial appendage. The ablation catheter will be left in place to guide the EP physicians in placing the right and left atrial flutter lines using radiofrequency. Electromagnetic mapping using a CARTO system and measuring for conduction block of the pulmonary veins will be conducted by the EP's. A second small port will then placed in the left thoracic cavity and the pericardium on the left side will be opened and the left atrial appendage will be ablated with the use of a clip placed around the left atrial appendage and tightened.
Active Comparator: Cox Maze Procedure All lesions of the Cox Maze procedure will be completed as originally described by Dr. James Cox using crypthermia. Patients will be randomized if there left atrium is >5.0 cm but < 6.1 cm and are experiencing paroxysmal or persistent atrial fibrillation	Procedure: The Cox Maze Procedure for Ablation of Atrial Fibrillation A 7-cm incision is placed and the chest is entered through the 4th or 5th intercostal space. The femoral artery and femoral vein are cannulated. The pericardium is opened. Cardiopulmonary bypass is instituted. The right sided lesions are applied using 3 purse-strings that are placed over the right atrial free wall. The right and left atrial lesions are done using cryoablation using either nitrous oxide or Argon. Next the left atrium is entered through a standard atriotomy placed in the interatrial groove. The base of the left atrial appendage is cryoablated and connected to the left upper pulmonary vein. All four pulmonary veins are then encircled using multiple application of cryo. An endocardial cryolesion is then placed posteriorly down to the level of the mid-mitral valve annulus and an epicardial cryolesion is placed on the coronary sinus directly across the atrial wall from the endocardial lesion. The left atrial appendage is then surgically managed.
Experimental: Hybrid Procedure A collaborative approach between electrophysiologist and surgeons for patients with a left atrium <5.0 cm and < 6.1 cm where the surgeon will epicardially place the ablation lesions and the electrophysiologist will place the lesion lines endocardially. 3D mapping will be used and the left atrial appendage will be surgically managed.	Procedure: Hybrid Procedure for Left Atrium >5 cm but < 6.1 cm The endoscope will be passed though a small port in the right thoracic cavity to the beating heart. The pericardium will be opened, the coronary sinus transected. The ablation catheters will pass underneath the SVC and IVC establishing access to the transverse and oblique sinuses. A box lesion will be epicardially placed around the pulmonary veins using cryothermia. An additional lesion line will be placed from the box lesion to the left atrial appendage. The ablation catheter will be left in place to guide the EP physicians in placing the right and left atrial flutter lines using radiofrequency. Electromagnetic mapping using a CARTO system and measuring for conduction block of the pulmonary veins will be conducted by the EP's. A second small port will then placed in the left thoracic cavity and the pericardium on the left side will be opened and the left atrial appendage will be ablated with the use of a clip placed around the left atrial appendage and tightened.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients will be included if they present for ablation with paroxysmal or persistent atrial fibrillation as defined by the Heart Rhythm Society and their left atrium is < 6.1 cm (volume)
Patients must be symptomatic with their AF as noted by their inability to perform their daily activities due to shortness of breath, fatigue, palpitations or other debilitating symptoms
Paroxysmal atrial fibrillation is defined as atrial fibrillation that resolves on its own within 7 days of onset
Persistent atrial fibrillation is defined as atrial fibrillation that does not resolve on its own and requires medical intervention to include medication therapy and/or electric cardioversion

Exclusion Criteria:

Patients will be excluded if they present with long standing persistent atrial fibrillation as defined by the Heart Rhythm Society
All patients with MV +2 mitral regurgitation will be excluded
Require other cardiac surgery procedures will be excluded
Are unable to take anticoagulation
Are unable to take any prescribed anti arrhythmic medication
Have a left atrium measuring greater than 6.0 cm (volume)
Have had previous catheter ablation for atrial fibrillation
Have had previous pace maker implantation
Are less than 18 years of age
Do not speak English and no translation can be provided
Are unable or unwilling to be followed according to set protocol to include obtaining an internally heart monitor 6 weeks prior to their ablation procedure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298986

Contacts

Contact: Niv Ad, MD	703-776-8308	niv.ad@inova.org
Contact: Linda L Henry, PhD, RN	703-776-7072	linda.henry@inova.org

Locations

United States, Virginia
Inova Heart and Vascular Institute	Recruiting
Falls Church, Virginia, United States, 22042
Contact: Linda Henry, PhD 703-776-7072 linda.henry@inova.org
Contact: Niv Ad, MD 703-776-8308 niv.ad@inova.org
Principal Investigator: Ted Friehling, MD
Sub-Investigator: Marc Wish, MD
Sub-Investigator: Sarfraz Durrani, MD
Sub-Investigator: Albert Del Negro, MD
Sub-Investigator: David Strouse, MD

Sponsors and Collaborators

Inova Health Care Services

More Information

No publications provided

Responsible Party:	Linda Henry, Research Investigator, Inova Health Care Services
ClinicalTrials.gov Identifier:	NCT01298986 History of Changes
Other Study ID Numbers:	10.126 Hybrid AF
Study First Received:	February 16, 2011
Last Updated:	February 21, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Inova Health Care Services:

atrial fibrillation ablation procedures

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012