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

NCT ID: NCT01363895

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous closure of LAA

Percutaneous closure of LAA

Group Type: ACTIVE_COMPARATOR

Percutaneous closure of LAA

Intervention Type: PROCEDURE

Percutaneous closure of LAA

Catheter ablation of AF

Catheter ablation of AF

Group Type: ACTIVE_COMPARATOR

Catheter ablation of AF

Intervention Type: PROCEDURE

Catheter ablation of AF

Interventions

Percutaneous closure of LAA

Percutaneous closure of LAA

Intervention Type: PROCEDURE

Catheter ablation of AF

Catheter ablation of AF

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients with oligosymptomatic AF eligible for both interventions (CA and LAA closure device implantation).

2. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.

3. In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria

1. Left atrial thrombus

2. Other indication than AF for oral anticoagulation (valve prosthesis, pulmonary embolism, recurrent vein thrombosis)

3. Contraindication for oral anticoagulation

4. Severe valvular heart disease

5. Severe left ventricular systolic function (ejection fraction<30%)

6. 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.

7. Pregnancy (present, suspected or planned) or positive pregnancy test.

8. Patient's inability to fully cooperate with the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Responsible Party

Deutsches Herzzentrum München

Principal Investigators

Albert Schömig, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum München

Steffen Massberg, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum München

Isabel Deisenhofer, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum München

Sonia Ammar, MD

Role: STUDY_DIRECTOR

Deutsches Herzentrum München

Julia Goedel, MD

Role: STUDY_DIRECTOR

Deutsches Herzzentrum München

Locations

Deutsches Herzzentrum München

Munich, , Germany

Countries

Germany

Other Identifiers

GER-EP-006

Identifier Type: -

Identifier Source: org_study_id