Atrial FibrillationAlster-LostNCT00820625
Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation
A study testing pulmonary vein isolation and pulmonary vein isolation with additional ablation of fragmented potentials in people with Atrial Fibrillation and Tachycardia, run by Asklepios proresearch at 1 site in Germany.
Trial summary
The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing persistent AF. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Tachycardia
- What is being tested?
- pulmonary vein isolation and pulmonary vein isolation with additional ablation of fragmented potentials
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Feb 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- long standing persistent atrial fibrillation > 6 months and < 5 years
Who cannot join
- renal failure
- left atrial size >55 mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation - Pulmonary Vein Isolation With or Without Ablation of Complex Fragmented Atrial Potentials
The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing persistent AF.
- Conditions
- Atrial Fibrillation, Tachycardia
- Being tested
- pulmonary vein isolation, pulmonary vein isolation with additional ablation of fragmented potentials
- Medical subject headings
- Atrial Fibrillation, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary vein isolationProcedure or surgery
common pulmonary vein isolation procedure
pulmonary vein isolation with additional ablation of fragmented potentialsProcedure or surgery
common pulmonary vein isolation with additional but also common ablation of fragmented potentials
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | ablation: pulmonary vein isolation Receives: Procedure: pulmonary vein isolation |
| 2 | Active comparator | ablation: pulmonary vein isolation with additional ablation of fragmented potentials Receives: Procedure: pulmonary vein isolation with additional ablation of fragmented potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
data collection in view of acute and chronic success rate
Measured: 12 months
Secondary outcomes (1)
data collection of complications in both groups and also procedure parameters
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 posted12 Jan 2009 (estimated)
- Study startMay 2008
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepios proresearch
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl-Heinz Kuck, PhD, MD, Principal investigator, Asklepios Klinik St. Georg, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820625
- Sponsor's protocol ID
- 1787
- Other IDs
- PV 2961
- Acronym
- Alster-Lost
- Status last verified
- Feb 2017
- First submitted
- 9 Jan 2009
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Fink T, Schluter M, Heeger CH, Lemes C, Maurer T, Reissmann B, Riedl J, Rottner L, Santoro F, Schmidt B, Wohlmuth P, Mathew S, Sohns C, Ouyang F, Metzner A, Kuck KH. Stand-Alone Pulmonary Vein Isolation Versus Pulmonary Vein Isolation With Additional Substrate Modification as Index Ablation Procedures in Patients With Persistent and Long-Standing Persistent Atrial Fibrillation: The Randomized Alster-Lost-AF Trial (Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation). Circ Arrhythm Electrophysiol. 2017 Jul;10(7):e005114. doi: 10.1161/CIRCEP.117.005114.
PubMed 28687670
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation - Pulmonary Vein Isolation With or Without Ablation of Complex Fragmented Atrial Potentials
- ClinicalTrials.gov ID
- NCT00820625
- Acronym / sponsor ID
- Alster-Lost / 1787
- Conditions
- Atrial Fibrillation, Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Asklepios proresearchIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 12 Jan 2009 (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.
The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing persistent AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: pulmonary vein isolationablation: pulmonary vein isolation |
| 2 | Active comparator | Procedure: pulmonary vein isolation with additional ablation of fragmented potentialsablation: pulmonary vein isolation with additional ablation of fragmented potentials |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- long standing persistent atrial fibrillation > 6 months and < 5 years
Key exclusion criteria (2 listed)
- renal failure
- left atrial size >55 mm
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 |
|---|---|---|
| pulmonary vein isolationcommon pulmonary vein isolation procedure | Procedure or surgery | 1 |
| pulmonary vein isolation with additional ablation of fragmented potentialscommon pulmonary vein isolation with additional but also common ablation of fragmented potentials | Procedure or surgery | 2 |
Primary outcome
data collection in view of acute and chronic success rate
Time frame: 12 months
1 secondary outcome
data collection of complications in both groups and also procedure parameters
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 8 Feb 2017.
- Derived from this study: PubMed 28687670Fink T, Schluter M, Heeger CH, Lemes C, Maurer T, Reissmann B, Riedl J, Rottner L, Santoro F, Schmidt B, Wohlmuth P, Mathew S, Sohns C, Ouyang F, Metzner A, Kuck KH. Stand-Alone Pulmonary Vein Isolation Versus Pulmonary Vein Isolation With Additional Substrate Modification as Index Ablation Procedures in Patients With Persistent and Long-Standing Persistent Atrial Fibrillation: The Randomized Alster-Lost-AF Trial (Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation). Circ Arrhythm Electrophysiol. 2017 Jul;10(7):e005114. doi: 10.1161/CIRCEP.117.005114.
- Individual participant dataSharing planned: Undecided
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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.
Karl-Heinz Kuck, PhD, MD principal investigator
Asklepios Klinik St. Georg, Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary vein isolation and pulmonary vein isolation with additional ablation of fragmented potentials in people with Atrial Fibrillation and Tachycardia, run by Asklepios proresearch 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 1 inclusion and 2 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 8 Feb 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?
data collection in view of acute and chronic success rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00820625, which also lists 1 linked publication.
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 8 Feb 2017.