Atrial Fibrillation Ablation and Autonomic Modulation Via Thorascopic Surgery

NCT01091389 | Completed Phase 4 DMC

• 1 other identifier: NL30199.018.10
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Totally Thoracoscopic PV isolation

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study is freedom of AF after one year after the procedure without the use of antiarrhythmic drugs.

  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.

  One year

Secondary Outcomes (2)

• Freedom of AF after two years after the procedure without the use of any antiarrhythmic drug

  Two Years

• Quality of life

  One Year

Study Arms (2)

GP ablation

EXPERIMENTAL

Thoracoscopic PV isolation with GP ablation

Procedure: Totally Thoracoscopic PV isolation

No GP ablation

EXPERIMENTAL

Thoracoscopic PV isolation with no GP ablation

Procedure: Totally Thoracoscopic PV isolation

Interventions

Totally Thoracoscopic PV isolation PROCEDURE

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.

Also known as: Mini-Maze, VATS-PVI

GP ablation; No GP ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Netherlands Heart Foundation: collaborator

Study Sites (1)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Amsterdam, 1100 DD, Netherlands

Location

Related Publications (4)

• Driessen AHG, Berger WR, Krul SPJ, van den Berg NWE, Neefs J, Piersma FR, Chan Pin Yin DRPP, de Jong JSSG, van Boven WP, de Groot JR. Ganglion Plexus Ablation in Advanced Atrial Fibrillation: The AFACT Study. J Am Coll Cardiol. 2016 Sep 13;68(11):1155-1165. doi: 10.1016/j.jacc.2016.06.036.

  PMID: 27609676 RESULT

• Wesselink R, Neefs J, van den Berg NWE, Meulendijks ER, Terpstra MM, Kawasaki M, Nariswari FA, Piersma FR, van Boven WJP, Driessen AHG, de Groot JR. Does left atrial epicardial conduction time reflect atrial fibrosis and the risk of atrial fibrillation recurrence after thoracoscopic ablation? Post hoc analysis of the AFACT trial. BMJ Open. 2022 Mar 9;12(3):e056829. doi: 10.1136/bmjopen-2021-056829.

  PMID: 35264365 DERIVED

• Reyat JS, Chua W, Cardoso VR, Witten A, Kastner PM, Kabir SN, Sinner MF, Wesselink R, Holmes AP, Pavlovic D, Stoll M, Kaab S, Gkoutos GV, de Groot JR, Kirchhof P, Fabritz L. Reduced left atrial cardiomyocyte PITX2 and elevated circulating BMP10 predict atrial fibrillation after ablation. JCI Insight. 2020 Aug 20;5(16):e139179. doi: 10.1172/jci.insight.139179.

  PMID: 32814717 DERIVED

• Berger WR, Neefs J, van den Berg NWE, Krul SPJ, van Praag EM, Piersma FR, de Jong JSSG, van Boven WP, Driessen AHG, de Groot JR. Additional Ganglion Plexus Ablation During Thoracoscopic Surgical Ablation of Advanced Atrial Fibrillation: Intermediate Follow-Up of the AFACT Study. JACC Clin Electrophysiol. 2019 Mar;5(3):343-353. doi: 10.1016/j.jacep.2018.10.008. Epub 2018 Nov 28.

  PMID: 30898238 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Maze Procedure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• J.R. De Groot, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 24, 2010
• Study Start: March 1, 2010
• Primary Completion: February 23, 2015
• Study Completion: January 1, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

NL (1)