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Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation (APPROACH AF)

Primary Purpose

Atrial Fibrillation, Persistent

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputation

Catheter pulmonary vein isolation without additional lesions

About this trial

This is an interventional treatment trial for Atrial Fibrillation, Persistent focused on measuring Catheter ablation, Thoracoscopic ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age is between 18 and 80 years
Persistent AF as defined following the ESC 2016 Guidelines, evidenced by 1) ongoing AF on the ECG or 2) documentation of AF necessitating cardioversion.
AF documented by ECG or Holter < 1 year ago.
At least one class I or III anti-arrhythmic drug in standard dosage has failed or is not tolerated.
Left atrial volume index ≤ 45 ml/m2
Legally competent and willing to sign the informed consent.
Willing and able to adhere to the follow-up visit protocol.
Life expectancy of at least 2 years.

Exclusion Criteria:

Prior intervention (catheter ablation or minimally-invasive thoracoscopic ablation) for AF.
AF is secondary to electrolyte imbalance, thyroid disease or other reversible or non-cardiovascular causes.
Documentation of CTI dependent atrial flutter
Valvular AF
Paroxysmal AF
Long standing Persistent AF, defined as AF continuously present for longer than 1 year.
Body mass index >35kg/m2
NYHA class IV heart failure symptoms or left ventricular ejection fraction <35%.
NYHA class III heart failure symptoms, unless caused or aggravated by AF.
Myocardial infarction within the preceding 2 months.
Active infection or sepsis (as evidenced by increased white blood cell count, elevated CRP level or fever >38,5 °C).
Known and documented carotid stenosis > 80%
Planned cardiac surgery for other purposes than AF.
Pregnancy or child bearing potential without adequate anticonception.
Requirement of anti-arrhythmic drugs 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 subject from the study)
Co-morbid condition that possesses undue risk of general anesthesia or port access cardiac surgery (in the opinion of the operator).
History of previous radiation therapy on the thorax
Circumstances that prevent follow-up
No vascular access for catheterization.
History of previous thoracotomy.
Factors precluding transseptal puncture for catheterization.

Sites / Locations

Amsterdam University Medical Center location AMCRecruiting
Maastricht UMC+
St. Antonius Ziekenhuis NieuwegeinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Thoracoscopic ablation

Catheter ablation

Arm Description

Thoracoscopic ablation

Catheter ablation

Outcomes

Primary Outcome Measures

Freedom of AF, defined as absence of any atrial tachyarrhythmia

The primary endpoint of the study is freedom of AF, defined as absence of any atrial tachyarrhythmia without the use of antiarrhythmic drugs once a total number of 72 patients with AF recurrences after a single procedure have been reached. This is an event based endpoint. Freedom of atrial tachyarrhythmia is defined as the absence of documentation of episodes of atrial tachyarrhythmia lasting more than 30 seconds on Holter recordings during follow-up and/or on ECGs recorded outside the scope of the study.

Secondary Outcome Measures

One year freedom of AF

Freedom of arrhythmia with or without AAD after a single procedure after one year

Freedom of AF after two procedures

Freedom of arrhythmia after 12 months with or without AAD after both procedures

Long term freedom of AF

- Freedom of arrhythmia after 5 years

Cost-effectiveness

- Cost-effectiveness of both procedures in isolation, and the combination of both procedures

Quality of life

Quality of life as determineed by AFEQT questionnaire

Full Information

NCT ID

NCT04715425

First Posted

January 13, 2021

Last Updated

January 18, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT04715425

Brief Title

Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation

Acronym

APPROACH AF

Official Title

Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 25, 2019 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Rationale: Atrial fibrillation (AF) is a highly prevalent cardiac arrhythmia. AF is classified as paroxysmal or persistent AF, based on the duration and persistency of the arrhythmia. Despite state-of-the-art pharmacological therapies targeting the ventricular rate or aiming to restore sinus rhythm, many patients with persistent AF stay symptomatic. Catheter ablation, endocardial pulmonary vein isolation (PVI) in particular, is the most commonly applied approach to treat drug refractory persistent AF, but particularly in this patient group results are modest. Alternatively, the PVs can be approached epicardially by thoracoscopic surgery to isolate the PVs. This approach is more efficacious, at the cost of a more invasive procedure and longer hospital stay. However, no studies have been conducted comparing catheter with thoracoscopic ablation in patients with persistent AF as a primary invasive procedure after failing treatment with anti-arrhythmic medication. Objective: This current study aims to assess a patient specific therapy plan for patients with persistent AF by randomizing thoracoscopic versus catheter ablation for PVI without adjuvant substrate ablation in those patients. Study design: This is a prospective, non-blinded randomized multicenter study. Subjects will be randomized (1:1) to one of the two study-arms (thoracoscopic surgical or catheter PVI). The follow-up will last 5 years, with heart rhythm monitoring at three and six months, one year and yearly in the following years. In case AF recurs during the first year, the subject will receive the treatment of the otherother arm, or according to patient choice or clinical routine. Study population: Patients with an indication for invasive treatment of persistent AF. Intervention: Thoracoscopic surgical or catheter PVI without additional lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Persistent

Keywords

Catheter ablation, Thoracoscopic ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Thoracoscopic ablation

Arm Type

Active Comparator

Arm Description

Thoracoscopic ablation

Arm Title

Catheter ablation

Arm Type

Active Comparator

Arm Description

Catheter ablation

Intervention Type

Procedure

Intervention Name(s)

Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputation

Intervention Description

Bilateral pulmonary vein isolation using radiofrequency energy

Intervention Type

Procedure

Intervention Name(s)

Catheter pulmonary vein isolation without additional lesions

Intervention Description

Bilateral pulmonary vein isolation using radiofrequency energy

Primary Outcome Measure Information:

Title

Freedom of AF, defined as absence of any atrial tachyarrhythmia

Description

Time Frame

Up until 72 patients experienced AF recurrence

Secondary Outcome Measure Information:

Title

One year freedom of AF

Description

Freedom of arrhythmia with or without AAD after a single procedure after one year

Time Frame

1 year of follow-up

Title

Freedom of AF after two procedures

Description

Freedom of arrhythmia after 12 months with or without AAD after both procedures

Time Frame

1 year of follow-up after the second procedure

Title

Long term freedom of AF

Description

- Freedom of arrhythmia after 5 years

Time Frame

5 years of follow-up

Title

Cost-effectiveness

Description

- Cost-effectiveness of both procedures in isolation, and the combination of both procedures

Time Frame

1 year of follow-up

Title

Quality of life

Description

Quality of life as determineed by AFEQT questionnaire

Time Frame

5 years of follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age is between 18 and 80 years Persistent AF as defined following the ESC 2016 Guidelines, evidenced by 1) ongoing AF on the ECG or 2) documentation of AF necessitating cardioversion. AF documented by ECG or Holter < 1 year ago. At least one class I or III anti-arrhythmic drug in standard dosage has failed or is not tolerated. Left atrial volume index ≤ 45 ml/m2 Legally competent and willing to sign the informed consent. Willing and able to adhere to the follow-up visit protocol. Life expectancy of at least 2 years. Exclusion Criteria: Prior intervention (catheter ablation or minimally-invasive thoracoscopic ablation) for AF. AF is secondary to electrolyte imbalance, thyroid disease or other reversible or non-cardiovascular causes. Documentation of CTI dependent atrial flutter Valvular AF Paroxysmal AF Long standing Persistent AF, defined as AF continuously present for longer than 1 year. Body mass index >35kg/m2 NYHA class IV heart failure symptoms or left ventricular ejection fraction <35%. NYHA class III heart failure symptoms, unless caused or aggravated by AF. Myocardial infarction within the preceding 2 months. Active infection or sepsis (as evidenced by increased white blood cell count, elevated CRP level or fever >38,5 °C). Known and documented carotid stenosis > 80% Planned cardiac surgery for other purposes than AF. Pregnancy or child bearing potential without adequate anticonception. Requirement of anti-arrhythmic drugs 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 subject from the study) Co-morbid condition that possesses undue risk of general anesthesia or port access cardiac surgery (in the opinion of the operator). History of previous radiation therapy on the thorax Circumstances that prevent follow-up No vascular access for catheterization. History of previous thoracotomy. Factors precluding transseptal puncture for catheterization.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

J.R. de Groot, MD PhD

Phone

0205699111

EP-research@amsterdamumc.nl

Facility Information:

Facility Name

Amsterdam University Medical Center location AMC

City

Amsterdam

Country

Netherlands

Individual Site Status

Recruiting

Facility Name

Maastricht UMC+

City

Maastricht

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Name

St. Antonius Ziekenhuis Nieuwegein

City

Nieuwegein

Country

Netherlands

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation

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