Atrial FibrillationISAR-AFNCT01363895
Interventional Strategies in Treatment of Atrial Fibrillation: Percutaneous Closure of the Left Atrial Appendage Versus Catheter Ablation
A study testing Percutaneous closure of LAA and Catheter ablation of AF in people with Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Percutaneous closure of LAA and Catheter ablation of AF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Percutaneous closure of LAA, Catheter ablation of AF
- Keywords
- atrial fibrillation, catheter ablation, percutaneous closure of LAA, intervention
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous closure of LAAProcedure or surgery
Percutaneous closure of LAA
Catheter ablation of AFProcedure or surgery
Catheter ablation of AF
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous closure of LAA | Active comparator | Percutaneous closure of LAA Receives: Procedure: Percutaneous closure of LAA |
| Catheter ablation of AF | Active comparator | Catheter ablation of AF Receives: Procedure: Catheter ablation of AF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
The individual components of the primary endpoint
Measured: 12 months
Discontinuation of anticoagulation
Measured: 12 months
Quality of Life
Measured: 12 months
Use of Antiarrhythmic Drugs
Measured: 12 months
freedom from symptomatic arrhythmia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Investigators
- Albert Schömig, MD, Study chair, Deutsches Herzzentrum MünchenSteffen Massberg, MD, Principal investigator, Deutsches Herzzentrum MünchenIsabel Deisenhofer, MD, Principal investigator, Deutsches Herzzentrum MünchenSonia Ammar, MD, Study director, Deutsches Herzentrum MünchenJulia Goedel, MD, Study director, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363895
- Sponsor's protocol ID
- GER-EP-006
- Acronym
- ISAR-AF
- Status last verified
- Apr 2017
- First submitted
- 25 Nov 2010
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Strategies in Treatment of Atrial Fibrillation: Percutaneous Closure of the Left Atrial Appendage Versus Catheter Ablation
- ClinicalTrials.gov ID
- NCT01363895
- Acronym / sponsor ID
- ISAR-AF / GER-EP-006
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation, percutaneous closure of LAA, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous closure of LAA | Active comparator | Procedure: Percutaneous closure of LAAPercutaneous closure of LAA |
| Catheter ablation of AF | Active comparator | Procedure: Catheter ablation of AFCatheter ablation of AF |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous closure of LAAPercutaneous closure of LAA | Procedure or surgery | Percutaneous closure of LAA |
| Catheter ablation of AFCatheter ablation of AF | Procedure or surgery | Catheter ablation of AF |
Primary outcome
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
Time frame: 12 months
5 secondary outcomes
The individual components of the primary endpoint
Time frame: 12 months
Discontinuation of anticoagulation
Time frame: 12 months
Quality of Life
Time frame: 12 months
Use of Antiarrhythmic Drugs
Time frame: 12 months
freedom from symptomatic arrhythmia
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Schömig, MD study chair
Deutsches Herzzentrum München
Steffen Massberg, MD principal investigator
Deutsches Herzzentrum München
Isabel Deisenhofer, MD principal investigator
Deutsches Herzzentrum München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous closure of LAA and Catheter ablation of AF in people with Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.