Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

An observational study of Heart Failure, run by Boston Scientific Corporation at 97 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead. Read more about this study

Who is it for?: Any age
Conditions the study is for: Heart Failure
What is being tested?: ACUITY Spiral Left Ventricular Lead
Type of treatment: Medical device
How many people: 1,308 participants
Where: 97 sitesUnited States
Study dates: 4 Aug 2009to 28 Feb 2018
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The population will be a broad base representative of those recieving the ACUITY Spiral lead.

Who may be able to join

Has been or will be implanted with the ACUITY Spiral Lead within 29 days
Plans to remain in the long-term care of his/her enrolling physician
Is willing and capable (or appropriate legal representative) of authorizing access to and use of health information as required by an institution's institutional review board (IRB)
Is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry

Who cannot join

Is unable or unwilling to comply with the protocol requirements

Trial locations and contacts

97 sites in 1 country.

City, postcode or hospital

97 sites in 1 country

United States97 sites

Abington Memorial Hospital
Abington, Pennsylvania, 19001
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
Capital Cardiology Associates
Albany, New York, 12208
Amarillo Heart Group
Amarillo, Texas, 79106
Providence Alaska Medical Center
Anchorage, Alaska, 99508
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Bethesda Memorial Hospital
Atlantis, Florida, 33462
Medical College of Georgia Health
Augusta, Georgia, 30912
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
Heart Hospital of Austin
Austin, Texas, 78756
Comprehensive Cardiovascular Medical Group
Bakersfield, California, 93309
Overlake Medical Center
Bellevue, Washington, 98004
St. Joseph Hospital
Bellingham, Washington, 98225
Birmingham Heart Clinic
Birmingham, Alabama, 35235
University of Alabama at Birmingham
Birmingham, Alabama, 35294
St Lukes Idaho Cardiology Assoc.
Boise, Idaho, 83712
Massachusetts General Hospital
Boston, Massachusetts, 02114
Steward St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Southern Kentucky Heart Institute
Bowling Green, Kentucky, 42101
Mid-Carolina Cardiology
Charlotte, North Carolina, 28204
Christ Hospital - Cincinnati
Cincinnati, Ohio, 45219
Heart and Vascular Institute of Florida
Clearwater, Florida, 33756
Missouri Heart Center
Columbia, Missouri, 65201
Columbia Cardiology
Columbia, South Carolina, 29204
Ohio State University Medical Center
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
Heart Care
Detroit, Michigan, 48201
St. Mary's Duluth Clinic
Duluth, Minnesota, 55805
Belott Cardiology
El Cajon, California, 92021
Cardiology Care Consultants
El Paso, Texas, 79902
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
Virginia Heart
Falls Church, Virginia, 22042
Cardiology Consultants of East Michigan
Flint, Michigan, 48507
PeeDee Cardiology Associates
Florence, South Carolina, 29505
Northern Indiana Research Alliance
Fort Wayne, Indiana, 46804
Fullerton Cardiovascular
Fullerton, California, 92835
Northeast Georgia Heart Center
Gainesville, Georgia, 30501
Island Cardiac Specialists
Garden City, New York, 11530
West Michigan Heart
Grand Rapids, Michigan, 49301
Associated Cardiologists
Harrisburg, Pennsylvania, 17112
St. Mary Medical Center - Indiana
Hobart, Indiana, 46342
Hall Garcia Cardiology
Houston, Texas, 77030
Houston Electrophysiology Associates
Houston, Texas, 77030
Willowbrook Cardiovascular Associates
Houston, Texas, 77030
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, 72401
Research Medical Center
Kansas City, Missouri, 64114
Central Baptist Hospital
Lexington, Kentucky, 40503
St. Joseph Hospital
Lexington, Kentucky, 40504
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Heart Clinic Arkansas
Little Rock, Arkansas, 72205
Cardiac Device Rhythm Specialists
Los Angeles, California, 90033
Cedars - Sinai Medical Center
Los Angeles, California, 90048
Commonwealth Cardiology
Louisville, Kentucky, 40202
Georgia Arrhythmia Consultants
Macon, Georgia, 31201
Richmond Cardiology Associates
Mechanicsville, Virginia, 23116
Memphis Heart Clinic
Memphis, Tennessee, 37501
Tri-City Cardiology
Mesa, Arizona, 85206
Miami International Cardiology Consultants
Miami, Florida, 33137
Memorial Hospital
Modesto, California, 95355
Heart Care Research Foundation
Mokena, Illinois, 60448
Intermountain Medical Center
Murray, Utah, 84107
Complete Cardiology Care
New Smyrna Beach, Florida, 32168
Columbia University Medical Center
New York, New York, 10032
Cardiac Rhythm Specialists, Inc.
Northridge, California, 91325
Cardiovascular Consultants
Oakland, California, 94609
Orange County Heart Institute
Orange, California, 92868
Orlando Regional Hospital
Orlando, Florida, 32806
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Pinehurst Cardiology Consultants
Pinehurst, North Carolina, 28374
Cardiovascular Associates of Rhode Island
Providence, Rhode Island, 02904
Eisenhower Medical Center
Rancho Mirage, California, 92270
Baltimore Heart Association
Randallstown, Maryland, 21133
Heart Doctors
Rapid City, South Dakota, 57701
Truong D Duong Cardiac Electrophysiology
Riverside, California, 92501
Regional Cardiology Associates
Sacramento, California, 95819
Sansum Clinic
Santa Barbara, California, 93102
Arizona Arrhythmia Research Center
Scottsdale, Arizona, 85258
Swedish Medical Center
Seattle, Washington, 98133
Providence Hospital
Southfield, Michigan, 48075
Heart Clinics Northwest
Spokane, Washington, 99204
Cox Health
Springfield, Missouri, 65807
Metro Heart Group South County
St Louis, Missouri, 63128
Dixie Regional Medical Center
St. George, Utah, 84790
Regional Cardiovascular Medical Center
Steubenville, Ohio, 43952
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
EP Heart
The Woodlands, Texas, 77384
West Coast Arrhythmia Center
Trinity, Florida, 34655
Pima Heart Physicians
Tucson, Arizona, 85712
Hillcrest Medical Center
Tulsa, Oklahoma, 74101
Tyler Cardiovascular Consultants
Tyler, Texas, 75701
Wheaton Franciscan Healthcare
Wauwatosa, Wisconsin, 53226
New Jersey Cardiology Associates
West Orange, New Jersey, 07052
Via-Christi Regional Medical Center
Wichita, Kansas, 67214
Lankenau Hospital
Wynnewood, Pennsylvania, 19096
Genesis Healthcare System
Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead

The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.

Conditions: Heart Failure
Being tested: ACUITY Spiral Left Ventricular Lead
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACUITY Spiral Left Ventricular LeadDevice
The implant of the ACUITY Spiral Lead

Study groups in NCT00955708
Study group	Role	What they receive
Implants		Patients successfully implanted with the ACUITY Spiral Lead Receives: Device: ACUITY Spiral Left Ventricular Lead

What is being measured

The primary outcome is the main question the study is designed to answer.

Chronic Left Ventricular Lead-related Complication Free Rate
Measured: Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 200928 Feb 2018

First posted10 Aug 2009 (estimated)
Study start4 Aug 2009
Primary completion28 Feb 2018
Study completion28 Feb 2018

Why it stopped: Early termination was granted by FDA based on study results meeting the post approval requirements.

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 Heart FailureStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,308 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00955708
Sponsor's protocol ID: LSR of ACUITY Spiral
Status last verified: Jul 2018
First submitted: 4 Aug 2009
Last updated: 2 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead
ClinicalTrials.gov ID: NCT00955708
Acronym / sponsor ID: LSR of ACUITY Spiral
Conditions: Heart Failure
Study type: Observational
Recruitment status: TerminatedReason stopped: Early termination was granted by FDA based on study results meeting the post approval requirements.
Enrolment: 1,308 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 4 Aug 2009 (actual)
Primary completion: 28 Feb 2018 (actual)
Study completion: 28 Feb 2018 (actual)
First posted: 10 Aug 2009 (estimated)
Results: Posted 2 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Implants	–	Device: ACUITY Spiral Left Ventricular LeadPatients successfully implanted with the ACUITY Spiral Lead

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The population will be a broad base representative of those recieving the ACUITY Spiral lead.

Key inclusion criteria (4 listed)

Has been or will be implanted with the ACUITY Spiral Lead within 29 days
Plans to remain in the long-term care of his/her enrolling physician
Is willing and capable (or appropriate legal representative) of authorizing access to and use of health information as required by an institution's institutional review board (IRB)
Is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry

Key exclusion criteria (1 listed)

Is unable or unwilling to comply with the protocol requirements

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
ACUITY Spiral Left Ventricular LeadThe implant of the ACUITY Spiral Lead	Device	Implants

Primary outcome

Chronic Left Ventricular Lead-related Complication Free Rate
Time frame: Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).

Results and safety

Results posted to the registry on 2 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implants	1,308	250

Primary outcome: Chronic Left Ventricular Lead-related Complication Free Rate

Time frame: Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).. Number (95% Confidence Interval). Unit: Percent free from event

Measure	Implants n = 1303
Value	95.3 (94.0 to NA)

Implants: Kaplan-Meier Rate: 95.3
Implants: Kaplan-Meier Rate: 100

Adverse events

Time frame: Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implants	117 of 1,303 (9%)	131 of 1,303 (10.1%)	269 of 1,303

Limitations and caveats (from the sponsor): Early termination was granted based on study results. The study was one-armed observational. The expected performance / safety of left ventricular leads has been established; permitting comparison to a pre-defined performance standard.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

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.

Olaf Hedrich, MD study director

Boston Scientific Corporation

97 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Boston Scientific Corporation at 97 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 4 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: stopped early, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 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 2 May 2019). 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?

Chronic Left Ventricular Lead-related Complication Free Rate (time frame: Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).). 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 NCT00955708.

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 2 May 2019.