Radiofrequency Ablation (RFA) Versus Antiarrhythmic Drug Treatment in Paroxysmal Atrial Fibrillation

NCT00133211 | Completed Phase 3 DMC

• 2 other identifiers: sks2005psh01NCT00133211
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation is the most common heart arrhythmia afflicting approximately 1% of the Danish population. Medical antiarrhythmic treatment is only moderately effective and has the risk of severe side effects. The present study is a prospective, randomized, multicentre study comparing medical antiarrhythmic drug strategy with catheter based radiofrequency strategy in patients with paroxysmal atrial fibrillation. The primary end point is atrial fibrillation burden (symptomatic and asymptomatic) judged by multiple 7-day Holter monitorings during 2 years follow-up. Three hundred patients considered candidates for antiarrhythmic drug treatment will be randomized. The study will be performed as a Scandinavian/German multicentre study.

Conditions

Atrial Fibrillation

Keywords

Paroxysmal atrial fibrillation; Heart arrhythmia; Ablation; Drug treatment

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation burden

  Two years

Secondary Outcomes (4)

• mortality

  2 years

• complications to treatment

  2 years

• Quality of life

  2 years

• Health economics

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Antiarrythmic drug treatment

Procedure: Radiofrequency ablation

2

EXPERIMENTAL

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

Pulmonary vein isolation

1; 2

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≤ 70 years of age
• Paroxysmal atrial fibrillation patients who are considered as being candidates for antiarrhythmic drug therapy initiation
• Patients who have had at least two episodes of symptomatic paroxysmal atrial fibrillation in the foregoing 6 months can be included. The atrial fibrillation episodes may be persistent (need DC- or AAD-conversion) with a duration of less than 7 days.

You may not qualify if:

• Previous or ongoing chronic treatment with class IC or class III antiarrhythmic drugs
• Intolerance/contraindication to class IC and class III antiarrhythmic drugs (i.e. intolerance/contraindication to only one of the two groups is not excluding the patient)
• Previous atrial fibrillation ablation
• Severely increased left atrial size
• Left ventricular ejection fraction below 0.40 (during sinus rhythm or atrial fibrillation with RR-intervals above 600 ms) or "eye-balled" reduction of systolic function to less than "moderately decreased".
• Contraindication to anticoagulation treatment with vitamin K antagonists
• Expected surgery for structural heart disease within the follow-up period Significant mitral valve disease
• New York Heart Association (NYHA) III-IV
• Planned pregnancy within the follow-up period
• Secondary atrial fibrillation (e.g. post-surgery, infections, hyperthyroidism)
• Age \< 18 years
• Patient does not want to participate.

Sponsors & Collaborators

• Danish Heart Foundation: lead

Study Sites (1)

Department of Cardiology

Aarhus, 8200, Denmark

Location

Related Publications (4)

• Nielsen JC, Johannessen A, Raatikainen P, Hindricks G, Walfridsson H, Pehrson SM, Englund A, Hartikainen J, Mortensen LS, Hansen PS; MANTRA-PAF Investigators. Long-term efficacy of catheter ablation as first-line therapy for paroxysmal atrial fibrillation: 5-year outcome in a randomised clinical trial. Heart. 2017 Mar;103(5):368-376. doi: 10.1136/heartjnl-2016-309781. Epub 2016 Aug 26.

  PMID: 27566295 DERIVED

• Walfridsson H, Walfridsson U, Nielsen JC, Johannessen A, Raatikainen P, Janzon M, Levin LA, Aronsson M, Hindricks G, Kongstad O, Pehrson S, Englund A, Hartikainen J, Mortensen LS, Hansen PS. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation: results on health-related quality of life and symptom burden. The MANTRA-PAF trial. Europace. 2015 Feb;17(2):215-21. doi: 10.1093/europace/euu342. Epub 2015 Jan 6.

  PMID: 25567068 DERIVED

• Aronsson M, Walfridsson H, Janzon M, Walfridsson U, Nielsen JC, Hansen PS, Johannessen A, Raatikainen P, Hindricks G, Kongstad O, Pehrson S, Englund A, Hartikainen J, Mortensen LS, Levin LA. The cost-effectiveness of radiofrequency catheter ablation as first-line treatment for paroxysmal atrial fibrillation: results from a MANTRA-PAF substudy. Europace. 2015 Jan;17(1):48-55. doi: 10.1093/europace/euu188. Epub 2014 Oct 23.

  PMID: 25341739 DERIVED

• Cosedis Nielsen J, Johannessen A, Raatikainen P, Hindricks G, Walfridsson H, Kongstad O, Pehrson S, Englund A, Hartikainen J, Mortensen LS, Hansen PS. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. N Engl J Med. 2012 Oct 25;367(17):1587-95. doi: 10.1056/NEJMoa1113566.

  PMID: 23094720 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jens Cosedis Nielsen, MD, DMSc

  Aarhus University Hospital Skejby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc, associate professor

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 23, 2005
• Study Start: September 1, 2005
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

DK (1)