Clinical trial NCT01363895: Interventional Strategies in Treatment of Atrial Fibrillation: Percutaneous Closure of the Left Atrial Appendage Versus Catheter Ablation
Official title: Interventional Strategies in Treatment of Atrial Fibrillation: Percutaneous Closure of the Left Atrial Appendage Versus Catheter Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
catheter ablation
percutaneous closure of LAA
intervention
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: The individual components of the primary endpoint
timeFrame: 12 months
measure: Discontinuation of anticoagulation
timeFrame: 12 months
measure: Quality of Life
timeFrame: 12 months
measure: Use of Antiarrhythmic Drugs
timeFrame: 12 months
measure: freedom from symptomatic arrhythmia
timeFrame: 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
Study officials:
affiliation: Deutsches Herzzentrum München
name: Albert Schömig, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum München
name: Steffen Massberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsches Herzzentrum München
name: Isabel Deisenhofer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsches Herzentrum München
name: Sonia Ammar, MD
role: STUDY_DIRECTOR
affiliation: Deutsches Herzzentrum München
name: Julia Goedel, MD
role: STUDY_DIRECTOR
References: