Sudden Cardiac DeathREASSURENCT01074034
REASSURE AV Registry
A study testing AV Therapy Assessment-B301 investigational device in people with Sudden Cardiac Death and Bradycardia, run by Boston Scientific Corporation at 36 sites in United States.
Trial summary
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death, Bradycardia
- What is being tested?
- AV Therapy Assessment-B301 investigational device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 36 sitesUnited States
- Study dates
- Apr 2006to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The patient is willing and capable of providing informed consent at an approved clinical investigational center, and able to attend the investigational center as required by the protocol
- Patient is implanted with an investigational B301 device as part of the REASSURE AV study
Who cannot join
- None
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Abington Memorial Hospital
Abington, Pennsylvania
Alaska Heart Institute
Anchorage, Alaska
Piedmont Hospital
Atlanta, Georgia
Boston Medical Center
Boston, Massachusetts
Deborah Heart and Lung Center
Browns Mills, New Jersey
Lahey Clinic Medical Center
Burlington, Massachusetts
Christ Hospital - Cincinnati
Cincinnati, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio
Ohio State University Medical Center
Columbus, Ohio
Baylor University Medical Center
Dallas, Texas
Mercy Hospital Medical Center
Des Moines, Iowa
Henry Ford Hospital
Detroit, Michigan
Good Samaritan Hospital
Downers Grove, Illinois
Saint Mary's Duluth Clinic
Duluth, Minnesota
Inova Fairfax Hospital
Fairfax, Virginia
St. Mary Medical Center
Hobart, Indiana
Center For Cardiac Arrhythmias
Houston, Texas
Northern California Heart Care
Larkspur, California
Sunrise Hospital & Medical Center
Las Vegas, Nevada
Central Baptist Hospital
Lexington, Kentucky
Louisville Cardiology Medical Group
Louisville, Kentucky
Medical Center Cardiologist Research
Louisville, Kentucky
Heart Care Research Foundation
Merrionette Park, Illinois
Ochsner Foundation Hospital
New Orleans, Louisiana
Mount Sinai Medical Center
New York, New York
Sentara Norfolk General Hospital
Norfolk, Virginia
Orlando Regional Hospital
Orlando, Florida
Owensboro Mercy Health System
Owensboro, Kentucky
Chippenham Medical Center
Richmond, Virginia
St. Joseph Hospital
Savannah, Georgia
Baystate Medical Center
Springfield, Massachusetts
St. Anthony's Medical Center
St Louis, Missouri
Heart and Vascular Institute
St. Petersburg, Florida
Hillcrest Medical Center
Tulsa, Oklahoma
Reading Hospital and Medical Center
West Reading, Pennsylvania
University of Massachusetts
Worcester, Massachusetts
About this study
Official title: Clinical Research Evaluation of the ASSURE Device Atrial and Ventricular Tachyarrhythmia Therapies Registry
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
Read the detailed description
The Guidant ASSURE device is a fully featured pacemaker with additional atrial and ventricular tachyarrhythmia therapy features. The REASSURE AV study is a clinical evaluation to support approval of these features. This clinical study is intended to provide adequate performance data on two atrial tachyarrhythmia management features, namely the ATS and atrial ATP. In addition data will be collected to verify that the ventricular tachyarrhythmia rescue shock feature performs as intended in the clinical setting in combination with other pacemaker functions.
- Conditions
- Sudden Cardiac Death, Bradycardia
- Being tested
- AV Therapy Assessment-B301 investigational device
- Medical subject headings
- Death, Sudden, Cardiac, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV Therapy Assessment-B301 investigational deviceDevice
Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
| Study group | Role | What they receive |
|---|---|---|
| AV Therapy Assessment group | Experimental | appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device Receives: Device: AV Therapy Assessment-B301 investigational device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inappropriate Shock Free Rate
Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks.
Measured: Three months post-implant
Secondary outcomes (1)
Conversion Success Rate up to Three Months Post-implant
For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery.
Measured: Three months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startApr 2006
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sudden Cardiac DeathStudies 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
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074034
- Sponsor's protocol ID
- G040067
- Acronym
- REASSURE
- Status last verified
- Jul 2017
- First submitted
- 22 Feb 2010
- Last updated
- 1 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Evaluation of the ASSURE Device Atrial and Ventricular Tachyarrhythmia Therapies Registry
- ClinicalTrials.gov ID
- NCT01074034
- Acronym / sponsor ID
- REASSURE / G040067
- Conditions
- Sudden Cardiac Death, Bradycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
Detailed description
The Guidant ASSURE device is a fully featured pacemaker with additional atrial and ventricular tachyarrhythmia therapy features. The REASSURE AV study is a clinical evaluation to support approval of these features. This clinical study is intended to provide adequate performance data on two atrial tachyarrhythmia management features, namely the ATS and atrial ATP. In addition data will be collected to verify that the ventricular tachyarrhythmia rescue shock feature performs as intended in the clinical setting in combination with other pacemaker functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AV Therapy Assessment group | Experimental | Device: AV Therapy Assessment-B301 investigational deviceappropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient is willing and capable of providing informed consent at an approved clinical investigational center, and able to attend the investigational center as required by the protocol
- Patient is implanted with an investigational B301 device as part of the REASSURE AV study
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| AV Therapy Assessment-B301 investigational deviceAtrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device | Device | AV Therapy Assessment group |
Primary outcome
Inappropriate Shock Free Rate
Time frame: Three months post-implant
Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks.
1 secondary outcome
Conversion Success Rate up to Three Months Post-implant
Time frame: Three months post-implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AV Therapy Assessment-B301 investigational device in people with Sudden Cardiac Death and Bradycardia, run by Boston Scientific Corporation at 36 sites in United States.
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 2 inclusion and 1 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Inappropriate Shock Free Rate (time frame: Three months post-implant). 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 1 Aug 2017.