Atrial FibrillationEVOLVENCT01196897
Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)
A study testing WATCHMAN LAA Closure Technology (Gen 4.0) in people with Atrial Fibrillation, run by Boston Scientific Corporation at 3 sites in 2 countries.
Trial summary
This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- WATCHMAN LAA Closure Technology (Gen 4.0)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2009to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paroxysmal, persistent, or permanent non-valvular atrial fibrillation
- Eligible for long-term Warfarin therapy;
- Eligible to come off Warfarin therapy if the LAA is sealed
- Calculated CHADS2 score of 1 or greater
Who cannot join
- New York Heart Association Class IV Congestive Heart Failure
- Recent MI (within 3 months)
- ASD and/or atrial septal repair or closure device
- Resting heart rate >110 bpm
- Has an implanted mechanical valve prosthesis
- Left atrial appendage is obliterated
Show all 11Show fewer
- Has undergone heart transplantation
- Has symptomatic carotid disease
- Contraindicated for aspirin
- LVEF < 30%
- Cardiac Tumor
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Sankt Katharinen Hospital / Cardiovasculares Centrum
Frankfurt, 60389
Krankenhaus der Barmherzige Bruder
Regensburg, Bavaria, 93049
About this study
Official title: Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients
This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study to evaluate the initial use of the next generation WATCHMAN Device.
- Conditions
- Atrial Fibrillation
- Being tested
- WATCHMAN LAA Closure Technology (Gen 4.0)
- Keywords
- Atrial fibrillation, Stroke, Warfarin, Coumadin, TIA, Trans Ischemic Attack
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATCHMAN LAA Closure Technology (Gen 4.0)Device
Implantation of the WATCHMAN device into the left atrial appendage.
| Study group | Role | What they receive |
|---|---|---|
| Implantable device | Experimental | WATCHMAN LAA Closure Technology (Gen 4.0) Receives: Device: WATCHMAN LAA Closure Technology (Gen 4.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure.
The implantation of the next generation WATCHMAN device without the occurrence of life-threatening events caused by the device and/or the procedure. These events may include device embolization requiring retrieval, bleeding events such as pericardial effusion requiring drainage, cardiac perforation requiring operation, cranial bleeding events due to any source, and any systemic embolic events related to the device or procedure.
Measured: 12-Months
Device Success
Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary.
Measured: Implant through 45-Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startMay 2009
- Primary completionSep 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.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivek Reddy, MD, Principal investigator, Na Homolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196897
- Sponsor's protocol ID
- CT1000
- Acronym
- EVOLVE
- Status last verified
- Aug 2012
- First submitted
- 16 Aug 2010
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients
- ClinicalTrials.gov ID
- NCT01196897
- Acronym / sponsor ID
- EVOLVE / CT1000
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Stroke, Warfarin, Coumadin, TIA, Trans Ischemic Attack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Sep 2010 (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.
This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study to evaluate the initial use of the next generation WATCHMAN Device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantable device | Experimental | Device: WATCHMAN LAA Closure Technology (Gen 4.0)WATCHMAN LAA Closure Technology (Gen 4.0) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Paroxysmal, persistent, or permanent non-valvular atrial fibrillation
- Eligible for long-term Warfarin therapy;
- Eligible to come off Warfarin therapy if the LAA is sealed
- Calculated CHADS2 score of 1 or greater
Key exclusion criteria (11 listed)
- New York Heart Association Class IV Congestive Heart Failure
- Recent MI (within 3 months)
- ASD and/or atrial septal repair or closure device
- Resting heart rate >110 bpm
- Has an implanted mechanical valve prosthesis
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 |
|---|---|---|
| WATCHMAN LAA Closure Technology (Gen 4.0)Implantation of the WATCHMAN device into the left atrial appendage. | Device | Implantable device |
Primary outcome
Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure.
Time frame: 12-Months
The implantation of the next generation WATCHMAN device without the occurrence of life-threatening events caused by the device and/or the procedure. These events may include device embolization requiring retrieval, bleeding events such as pericardial effusion requiring drainage, cardiac perforation requiring operation, cranial bleeding events due to any source, and any systemic embolic events related to the device or procedure.
Device Success
Time frame: Implant through 45-Days
Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary.
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 Dec 2015.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Vivek Reddy, MD principal investigator
Na Homolce Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WATCHMAN LAA Closure Technology (Gen 4.0) in people with Atrial Fibrillation, run by Boston Scientific Corporation at 3 sites in 2 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 4 inclusion and 11 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Czechia. 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?
Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure. (time frame: 12-Months). The study lists 2 primary outcomes in all. 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 8 Dec 2015.