Atrial Fibrillation Ablation and Autonomic Modulation Via Thorascopic Surgery (AFACT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Netherlands Heart Foundation
Information provided by (Responsible Party):
J.R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01091389
First received: March 23, 2010
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

This study aims at investigating the role of autonomic modulation of AF. Therefore, totally thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be studied against PV isolation alone. Two groups of patients (paroxysmal AF with or without structural heart disease and persistent AF with or without heart disease) of 110 patients each will be studied.


Condition Intervention Phase
Atrial Fibrillation
Procedure: Totally Thoracoscopic PV isolation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Single Center Study to Prospectively Investigate the Effect of Ablation of the Autonomic Ganglia in Addition to Minimally Invasive Surgical Isolation of Pulmonary Veins in Patients With Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • The primary endpoint of the study is freedom of AF after one year after the procedure without the use of antiarrhythmic drugs. [ Time Frame: One year ] [ Designated as safety issue: No ]
    The primary endpoint of the study is freedom of AF after one year after the procedure without the use of antiarrhythmic drugs. Freedom of AF is defined as the absence of documentation of AF on serial Holter recordings during follow up and on ECGs recorded outside the scope of the study. One single episode of <30 minutes is allowed. Patients complaints about palpitations without the documentation of AF is allowed.


Secondary Outcome Measures:
  • Freedom of AF after two years after the procedure without the use of any antiarrhythmic drug [ Time Frame: Two Years ] [ Designated as safety issue: No ]
    Freedom of AF after two years after the procedure without the use of any antiarrhythmic drug. Definition of freedom of AF as above.

  • Quality of life [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Improvement of functional status as measured by the RAND 36 quality of life questionnaires


Estimated Enrollment: 240
Study Start Date: March 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GP ablation
Thoracoscopic PV isolation with GP ablation
Procedure: Totally Thoracoscopic PV isolation
Surgery is performed through three ports bilaterally in the intercostal spaces. PVI is performed with a bipolar radiofrequency clamp and confirmed with a custom made multi-electrode probe with closely spaced (1mm) electrode terminals. Additional left atrial ablation lines are created and conduction block is verified in patients with persistent and permanent AF.
Other Names:
  • Mini-Maze
  • VATS-PVI
Experimental: No GP ablation
Thoracoscopic PV isolation with no GP ablation
Procedure: Totally Thoracoscopic PV isolation
Surgery is performed through three ports bilaterally in the intercostal spaces. PVI is performed with a bipolar radiofrequency clamp and confirmed with a custom made multi-electrode probe with closely spaced (1mm) electrode terminals. Additional left atrial ablation lines are created and conduction block is verified in patients with persistent and permanent AF.
Other Names:
  • Mini-Maze
  • VATS-PVI

Detailed Description:

Atrial fibrillation (AF) is the most common chronic arrhythmia in man. Its treatment consists of control of ventricular rate or attempts to restore sinus rhythm. For symptomatic patients who fail on anti arrhythmic drugs, isolation of the pulmonary veins (PV), with additional linear left atrial lesions when appropriate, can cure AF. At least in some, but probably in many patients, the autonomous nervous system plays a pivotal role in the initiation and perpetuation of AF. The autonomic ganglia, or ganglionated plexi (GP) are located within the epicardial fat pads of the left atrium. This study aims at investigating the additional value of ablation of those GPs in addition to totally thoracoscopic PV isolation.

Objective of the study:

This study aims at investigating the role of autonomic modulation of AF. Therefore, totally thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be studied against PV isolation alone. Two groups of patients (paroxysmal AF with or without structural heart disease and persistent AF with or without heart disease) of 110 patients each will be studied.

Study design:

This is a single center, randomized single blinded study

Study population:

Any patient with an indication for non-pharmacological treatment of symptomatic paroxysmal or persistent AF can enter the study. An indication for non-pharmacological treatment exists when patients are symptomatic and have failed on at least one anti-arrhythmic drug. Symptoms of AF include, but are not limited to palpitations, reduced exercise capacity, exertional dyspnea, and fatigue. Failure of anti-arrhythmic therapy is defined as 1) recurrence of AF despite the use of an anti-arrhythmic drug in a clinical efficacious dosing or 2) adverse effects of medication that is not acceptable to the patient.

Intervention (if applicable):

In patients randomized to additional GP ablation, the following procedures will be carried out during the totally thoracoscopic procedure in addition to the PV isolation (and extended lesion set when appropriate): The left atrial autonomic GPs are localized within the epicardial fat pads and subsequently ablated with radiofrequency current delivered through an ablation probe (AtriCure Isolator™ Transpolar™ pen).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age is between 18 and 80 years
  • AF is symptomatic, paroxysmal or persistent (hence not long standing persistent)
  • In case of persistent AF, successful cardioversion within the last 12 months (cardioversion will be considered failed if AF recurs within 48 hours)
  • AF was documented on ECG, Holter or pacemaker electrogram at least once in the 6 months preceding presentation
  • At least one class I or III antiarrhythmic drug in standard dosage has failed or is not tolerated
  • Legally competent and willing and able to sign informed consent
  • Willing and able to adhere to the follow up visit protocol
  • Life expectancy of ≥2 years

Exclusion Criteria:

  • Prior catheter ablation for AF within the preceding 4 months
  • Refusal to take antiarrhythmic medication
  • Myocardial infarction (defined as CKMB> twice upper limit of normal) within the preceding 2 months
  • NYHA class IV/IV heart failure symptoms, or class II-III with a recent decompensation requiring hospitalization or left ventricular ejection fraction<35% (unless related to or aggravated by AF).
  • Cerebrovascular accident (defined as any sudden neurological deficit lasting longer than 24 hours, with or without pathological changes on the CT cerebrum) with the preceding 6 months
  • Known and documented carotid stenosis>80%
  • Planned cardiac surgery for other purposes than AF (alone)
  • Evidence of active infection (as evidenced by increased white blood cell count, elevated CRP level or fever >38,5 °C)
  • Unable to undergo TEE
  • Pregnancy or of childbearing potential without adequate contraception
  • Requirement of antiarrhythmic medication for ventricular arrhythmias
  • Presence of intracardiac mass or thrombus (Discovery of any thrombus or intracardiac mass after signing of the informed consent will result in withdrawal of the patient from the study)
  • Co-morbid condition that possesses undue risk of general anesthesia or port access cardiac surgery (in the opinion of the investigator)
  • History of previous radiation therapy on the thorax
  • Circumstances that prevent follow-up (no permanent home or address, transient, etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091389

Contacts
Contact: J.R. de Groot, MD, PhD +3120-5669111 j.r.degroot@amc.uva.nl
Contact: S.P.J. Krul, MD +3120-5667731 s.p.j.krul@amc.uva.nl

Locations
Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Recruiting
Amsterdam, Netherlands, 1100 DD
Contact: J.R. de Groot, MD, PhD    +3120-5669111    j.r.degroot@amc.uva.nl   
Contact: S.P.J. Krul, MD    +3120-5667883    s.p.j.krul@amc.uva.nl   
Principal Investigator: J.R. De Groot, MD, PhD         
Sub-Investigator: S.P.J. Krul, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Netherlands Heart Foundation
Investigators
Principal Investigator: J.R. De Groot, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

Responsible Party: J.R. de Groot, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01091389     History of Changes
Other Study ID Numbers: NL30199.018.10
Study First Received: March 23, 2010
Last Updated: May 31, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Atrial Fibrillation
Totally Thoracoscopic PV isolation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014