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

Who is this study for? Patients with persistent atrial fibrillation
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Amsterdam University Medical Center location AMC
RECRUITING
Amsterdam
Maastricht UMC+
NOT_YET_RECRUITING
Maastricht
St. Antonius Ziekenhuis Nieuwegein
RECRUITING
Nieuwegein
Contact Information
Primary
J.R. de Groot, MD PhD
EP-research@amsterdamumc.nl
0205699111
Time Frame
Start Date: 2019-09-25
Estimated Completion Date: 2028-09
Participants
Target number of participants: 170
Treatments
Active_comparator: Thoracoscopic ablation
Thoracoscopic ablation
Active_comparator: Catheter ablation
Catheter ablation
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov