Paroxysmal Atrial FibrillationNCT02275260
Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study
A study testing Cerebral Diffusion-Weighted Magnetic Resonance Imaging, Transesophageal Echocardiography and Paperbased neurocognitive testing in people with Paroxysmal Atrial Fibrillation, run by Biotronik SE & Co. KG at 14 sites in 5 countries.
Trial summary
The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical data from the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Cerebral Diffusion-Weighted Magnetic Resonance Imaging, Transesophageal Echocardiography and Paperbased neurocognitive testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Dec 2014to 15 Feb 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Electrocardiographically documented, symptomatic paroxysmal AF.
- Patients with indication for left atrial ablation of AF according to ESC guidelines for the management of atrial fibrillation.
- Anticoagulation according to clinical routine using coumarin derivates with target INR between 2.0 and 3.0 at least 3 weeks prior to the scheduled ablation procedure or novel oral anticoagulants (NOACs).
- Geographically stable for the duration of the study.
- Willingness and ability to perform written informed consent
Who cannot join
- Long standing persistent or persistent AF
- CHA2DS2-VASc score ≥ 5
- Prior ischemic stroke or Transient Ischemic Attack
- Previous Pulmonary Vein ablation
- Contraindication for anticoagulation therapy
- Contraindication for Diffusion-Weighted MRI
Show all 19Show fewer
- Claustrophobia
- Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE, if TEE not possible)
- Implanted cardiovascular device, including but not limited to an atrial or ventricular pacemaker or defibrillator leads, artificial valves, stents, septal or LAA occluders
- Acute coronary syndrome < 3 months prior to scheduled ablation
- Moderate to severe valvular heart disease
- LA size > 55 mm (confirming echo at maximum 3 months old)
- Patients with non-controlled heart failure or patients with current and recent (< 1 month prior to ablation) heart failure
- Ejection fraction < 35% (confirming echo at maximum 3 months old)
- Conditions that prevent patient's participation in neurocognitive assessment (at physician's discretion)
- Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study
- Any limitation to contractual capability
- Simultaneous participation in another study
- Age < 18 years
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Germany8 sites
Kerckhoff-Klinik
Bad Nauheim
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
Charité Campus Benjamin Franklin
Berlin
Charité Campus Virchow
Berlin
Cardioangologisches Centrum Bethanien (CCB)
Frankfurt am Main
Universität Leipzig
Leipzig
Deutsches Herzzentrum München des Freistaates Bayern
Munich
Peter Osypka Herzzentrum München
Munich
Czechia2 sites
Ceske Budejovice Hospital
České Budějovice
Institute for Clinical and Experimental Medicine (IKEM)
Prague
Netherlands2 sites
OLVG - Onze Lieve Vrouwe Gasthuis
Amsterdam
Haga Ziekenhuis
The Hague
About this study
Official title: Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study (REDUCE-TE Pilot)
The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical data from the literature.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Cerebral Diffusion-Weighted Magnetic Resonance Imaging, Transesophageal Echocardiography, Paperbased neurocognitive testing
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral Diffusion-Weighted Magnetic Resonance ImagingDevice
Also called 1.5-3 T machine capable of Diffusion-Weighted MRI
Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI)
Transesophageal EchocardiographyDevice
Also called Any Transesophageal Echocardiography machine
Patients undergo a Transesophageal Echocardiography prior to the ablation itself
Paperbased neurocognitive testingOther
Also called STATE questionnaire, d2 test, visual VVM2, MOCA subtest
To assess the impact of PVI on the patient's neurocognitive status
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All patients undergo cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Transesophageal (or Intracardial) Echocardiography and paperbased neurocognitive testing Receives: Device: Cerebral Diffusion-Weighted Magnetic Resonance Imaging; Device: Transesophageal Echocardiography; Other: Paperbased neurocognitive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolic lesions
The occurrence of one or more new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation assessed by Diffusion-Weighted MRI
Measured: 1-3 days
Secondary outcomes (3)
Neurocognitive status
To assess the impact of PVI on the patient's neurocognitive status measured by a testing battery including the STATE questionnaire, d2 test of attention, visual part of the visual and verbal memory test (VVM2) and Montreal Cognitive Assessment (MOCA) subtest
Measured: Baseline, 1-3 days and 3 months
Peri-procedural serious adverse events
Any serious adverse event occurring during the ablation procedure and within 24 hours from completion of the procedure
Measured: Within 24 hours after ablation
Post-procedural clinical TE events
Composite endpoint: Occurrence of Transient Ischemic Attack and/or Ischemic Stroke and/or Systemic Embolism during the three months post-ablation period (excluding peri-procedural events)
Measured: 3 months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startDec 2014
- Primary completion8 Feb 2017
- Study completion15 Feb 2018
Why it stopped: The required number of endpoints will be obtained with a sample size lower than initially planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Heidelberg
- Responsible party
- Sponsor
- Investigators
- Dipen Shah, Prof. Dr., Study chair, Hôpitaux Universitaires de Genève, SwitzerlandBoris Schmidt, PD Dr., Study chair, Cardioangiologisches Centrum Bethanien, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275260
- Sponsor's protocol ID
- EP025
- Status last verified
- May 2018
- First submitted
- 21 Oct 2014
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Akca F, Zima E, Vegh EM, Szeplaki G, Skopal J, Hubay M, Lendvai Z, Merkely B, Szili-Torok T. Radiofrequency ablation at low irrigation flow rates using a novel 12-hole gold open-irrigation catheter. Pacing Clin Electrophysiol. 2013 Nov;36(11):1373-81. doi: 10.1111/pace.12215. Epub 2013 Jul 22.
PubMed 23875670Balazs T, Laczko R, Bognar E, Akman S, Nagy P, Zima E, Dobranszky J, Szili-Torok T. Ablation time efficiency and lesion volume - in vitro comparison of 4 mm, non irrigated, gold- and platinum-iridium-tip radiofrequency ablation catheters. J Interv Card Electrophysiol. 2013 Jan;36(1):13-8; discussion 18. doi: 10.1007/s10840-012-9743-9. Epub 2012 Oct 26.
PubMed 23100094Linhart M, Liberman I, Schrickel JW, Mittmann-Braun EL, Andrie R, Stockigt F, Kreuz J, Nickenig G, Lickfett LM. Superiority of gold versus platinum irrigated tip catheter ablation of the pulmonary veins and the cavotricuspid isthmus: a randomized study comparing tip temperatures and cooling flow requirements. J Cardiovasc Electrophysiol. 2012 Jul;23(7):717-21. doi: 10.1111/j.1540-8167.2011.02267.x. Epub 2012 Mar 19.
PubMed 22429859Lewalter T, Weiss C, Spencker S, Jung W, Haverkamp W, Willems S, Deneke T, Kautzner J, Wiedemann M, Siebels J, Pitschner HF, Hoffmann E, Hindricks G, Zabel M, Vester E, Schwacke H, Mittmann-Braun E, Lickfett L, Hoffmeister S, Proff J, Mewis C, Bauer W; AURUM 8 Study Investigators. Gold vs. platinum-iridium tip catheter for cavotricuspid isthmus ablation: the AURUM 8 study. Europace. 2011 Jan;13(1):102-8. doi: 10.1093/europace/euq339. Epub 2010 Sep 28.
PubMed 20876601
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study (REDUCE-TE Pilot)
- ClinicalTrials.gov ID
- NCT02275260
- Acronym / sponsor ID
- EP025
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The required number of endpoints will be obtained with a sample size lower than initially planned.
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Heidelberg
- Study start
- Dec 2014 (actual)
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 27 Oct 2014 (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 REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical data from the literature.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: Cerebral Diffusion-Weighted Magnetic Resonance Imaging, Device: Transesophageal Echocardiography, Other: Paperbased neurocognitive testingAll patients undergo cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Transesophageal (or Intracardial) Echocardiography and paperbased neurocognitive testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Electrocardiographically documented, symptomatic paroxysmal AF.
- Patients with indication for left atrial ablation of AF according to ESC guidelines for the management of atrial fibrillation.
- Anticoagulation according to clinical routine using coumarin derivates with target INR between 2.0 and 3.0 at least 3 weeks prior to the scheduled ablation procedure or novel oral anticoagulants (NOACs).
- Geographically stable for the duration of the study.
- Willingness and ability to perform written informed consent
Key exclusion criteria (19 listed)
- Long standing persistent or persistent AF
- CHA2DS2-VASc score ≥ 5
- Prior ischemic stroke or Transient Ischemic Attack
- Previous Pulmonary Vein ablation
- Contraindication for anticoagulation therapy
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 |
|---|---|---|
| Cerebral Diffusion-Weighted Magnetic Resonance ImagingAlso: 1.5-3 T machine capable of Diffusion-Weighted MRIPatients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) | Device | All patients |
| Transesophageal EchocardiographyAlso: Any Transesophageal Echocardiography machinePatients undergo a Transesophageal Echocardiography prior to the ablation itself | Device | All patients |
| Paperbased neurocognitive testingAlso: STATE questionnaire, d2 test, visual VVM2, MOCA subtestTo assess the impact of PVI on the patient's neurocognitive status | Other | All patients |
Primary outcome
Thromboembolic lesions
Time frame: 1-3 days
The occurrence of one or more new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation assessed by Diffusion-Weighted MRI
3 secondary outcomes
Neurocognitive status
Time frame: Baseline, 1-3 days and 3 months
Peri-procedural serious adverse events
Time frame: Within 24 hours after ablation
Post-procedural clinical TE events
Time frame: 3 months period
Results and safety
The study was stopped early (reason given: The required number of endpoints will be obtained with a sample size lower than initially planned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Background: PubMed 23875670Akca F, Zima E, Vegh EM, Szeplaki G, Skopal J, Hubay M, Lendvai Z, Merkely B, Szili-Torok T. Radiofrequency ablation at low irrigation flow rates using a novel 12-hole gold open-irrigation catheter. Pacing Clin Electrophysiol. 2013 Nov;36(11):1373-81. doi: 10.1111/pace.12215. Epub 2013 Jul 22.
- Background: PubMed 23100094Balazs T, Laczko R, Bognar E, Akman S, Nagy P, Zima E, Dobranszky J, Szili-Torok T. Ablation time efficiency and lesion volume - in vitro comparison of 4 mm, non irrigated, gold- and platinum-iridium-tip radiofrequency ablation catheters. J Interv Card Electrophysiol. 2013 Jan;36(1):13-8; discussion 18. doi: 10.1007/s10840-012-9743-9. Epub 2012 Oct 26.
- Background: PubMed 22429859Linhart M, Liberman I, Schrickel JW, Mittmann-Braun EL, Andrie R, Stockigt F, Kreuz J, Nickenig G, Lickfett LM. Superiority of gold versus platinum irrigated tip catheter ablation of the pulmonary veins and the cavotricuspid isthmus: a randomized study comparing tip temperatures and cooling flow requirements. J Cardiovasc Electrophysiol. 2012 Jul;23(7):717-21. doi: 10.1111/j.1540-8167.2011.02267.x. Epub 2012 Mar 19.
- Background: PubMed 20876601Lewalter T, Weiss C, Spencker S, Jung W, Haverkamp W, Willems S, Deneke T, Kautzner J, Wiedemann M, Siebels J, Pitschner HF, Hoffmann E, Hindricks G, Zabel M, Vester E, Schwacke H, Mittmann-Braun E, Lickfett L, Hoffmeister S, Proff J, Mewis C, Bauer W; AURUM 8 Study Investigators. Gold vs. platinum-iridium tip catheter for cavotricuspid isthmus ablation: the AURUM 8 study. Europace. 2011 Jan;13(1):102-8. doi: 10.1093/europace/euq339. Epub 2010 Sep 28.
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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.
Dipen Shah, Prof. Dr. study chair
Hôpitaux Universitaires de Genève, Switzerland
Boris Schmidt, PD Dr. study chair
Cardioangiologisches Centrum Bethanien, Germany
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral Diffusion-Weighted Magnetic Resonance Imaging, Transesophageal Echocardiography and Paperbased neurocognitive testing in people with Paroxysmal Atrial Fibrillation, run by Biotronik SE & Co. KG at 14 sites in 5 countries.
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 5 inclusion and 19 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: stopped early, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Czechia, Netherlands, Hungary, Switzerland. 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 was stopped early (reason given: The required number of endpoints will be obtained with a sample size lower than initially planned.). Results are not available in the source record.
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?
Thromboembolic lesions (time frame: 1-3 days). 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 NCT02275260, which also lists 4 linked publications.
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 1 Nov 2019.