Interventional Strategies in Treatment of Atrial Fibrillation: Percutaneous Closure of the Left Atrial Appendage Versus Catheter Ablation

NCT01363895 | Completed DMC

• 1 other identifier: GER-EP-006
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, associated with an increased risk of morbidity and mortality1. The management of AF patients is aimed at reducing symptoms and at preventing severe complications associated with AF. In the last years, two new strategies have emerged with different objectives. In the PROTECT AF study2, percutaneous closure of the Left Atrial Appendage (LAA) with a closure device provided an alternative strategy to oral anticoagulation for stroke prophylaxis. The AFFIRM trial3 has shown that drug-based management of AF with a rhythm-control strategy conferred no advantage over a rate-control strategy in cardiovascular mortality and might be associated with an increased noncardiovascular death rate4. Catheter ablation has gained a greater place in the rhythm control strategy, showing superiority in maintaining sinus rhythm in comparison with AAD5. However, in persistent AF, repeat ablation procedures are necessary in up to 70% of patients to achieve sinus rhythm at a long-term follow-up6-7. This prospective, randomized trial will compare the percutaneous closure of the LAA combined with a rate-control strategy to catheter ablation in the management of patients with persistent AF. Patients who are eligible for catheter ablation as well as LAA closure device implantation and are willing to participate in the study will be randomly assigned to catheter ablation or percutaneous closure of the LAA by a closure device implantation in the relation 1:1. The primary endpoint of the study is a composite endpoint at 12 months of all cause death, thrombo-embolic events, major bleeding (BARC type 3), re-hospitalisation and severe symptoms due to arrhythmias. Secondary endpoints include a composite endpoint of bleeding, a composite endpoint of thrombo-embolic events, cardio-vascular mortality, total duration of hospitalisation, sustained discontinued anticoagulation, quality of life improvement, use of Antiarrhythmic Drugs (AAD), total costs, freedom from arrhythmia and average ventricular frequency in 7-day holter ECG at 12 months. The objective of the study is to assess the superiority of percutaneous closure of the LAA combined with rate-control to catheter ablation in patients with oligosymptomatic AF.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; catheter ablation; percutaneous closure of LAA; intervention

Outcome Measures

Primary Outcomes (1)

• A 12-month composite endpoint of all cause death, thrombo-embolic events, major bleeding BARC type III, re-hospitalisation and severe symptoms due to arrhythmias

  12 months

Secondary Outcomes (5)

• The individual components of the primary endpoint

  12 months

• Discontinuation of anticoagulation

  12 months

• Quality of Life

  12 months

• Use of Antiarrhythmic Drugs

  12 months

• freedom from symptomatic arrhythmia

  12 months

Study Arms (2)

Percutaneous closure of LAA

ACTIVE COMPARATOR

Percutaneous closure of LAA

Procedure: Percutaneous closure of LAA

Catheter ablation of AF

ACTIVE COMPARATOR

Catheter ablation of AF

Procedure: Catheter ablation of AF

Interventions

Percutaneous closure of LAA PROCEDURE

Percutaneous closure of LAA

Percutaneous closure of LAA

Catheter ablation of AF PROCEDURE

Catheter ablation of AF

Catheter ablation of AF

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with oligosymptomatic AF eligible for both interventions (CA and LAA closure device implantation).
• Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
• In women with childbearing potential a negative pregnancy test is mandatory.

You may not qualify if:

• Left atrial thrombus
• Other indication than AF for oral anticoagulation (valve prosthesis, pulmonary embolism, recurrent vein thrombosis)
• Contraindication for oral anticoagulation
• Severe valvular heart disease
• Severe left ventricular systolic function (ejection fraction\<30%)
• Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
• Pregnancy (present, suspected or planned) or positive pregnancy test.
• Patient's inability to fully cooperate with the study protocol.

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (1)

Deutsches Herzzentrum München

Munich, 80636, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Albert Schömig, MD

  Deutsches Herzzentrum München

  STUDY CHAIR

• Steffen Massberg, MD

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

• Isabel Deisenhofer, MD

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

• Sonia Ammar, MD

  Deutsches Herzentrum München

  STUDY DIRECTOR

• Julia Goedel, MD

  Deutsches Herzzentrum München

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2010
• First Posted: June 2, 2011
• Study Start: November 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2013
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

DE (1)