Sick Sinus SyndromeSAVEPACeNCT00284830
SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction
A study testing Implantable Pulse Generators in people with Sick Sinus Syndrome and Heart Failure, Congestive, run by Medtronic Cardiac Rhythm and Heart Failure at 67 sites in 2 countries.
Trial summary
SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outcome of time to development of persistent AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sick Sinus Syndrome, Heart Failure, Congestive, Atrial Fibrillation
- What is being tested?
- Implantable Pulse Generators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,070 participants
- Where
- 67 sitesin 2 countries
- Study dates
- Jan 2003to Feb 2008
- 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
- 18 years of age and older
- Willing and able to give informed consent
- Willing and able to comply with the study follow-up schedule
- Class I/ClassII indications for dual chamber pacing
- Initial implant of a Kappa 700, Kappa 900, EnPulse, or EnRhythm dual chamber IPG
- Demonstrate 1 to 1 conduction and a QRS interval of < 120ms at 100 beats per minutes for a period of nine seconds while atrial pacing
Who cannot join
- Less than 18 years of age
- Unwilling or unable to give informed consent
- Unwilling or unable to commit to follow-up schedule
- Medical conditions that would preclude the testing required by the protocol or limit study participation
- Enrolled or intend to participate in another clinical trial during the course of this study
- A life expectancy of less than 2 years
Show all 13Show fewer
- History of continuous atrial fibrillation for the 6 months prior to screen visit
- Two or more cardioversions, chemical or electrical, within the past 6 months prior to screen
- History of persistent second or third degree atrioventricular block
- A prior implant of pacemaker or defibrillator device
- A baseline, pre-paced QRS >120 ms on surface ECG
- Failure of the 1 to 1 atrioventricular conduction test
- Anticipated major cardiac surgery within the course of the study
Trial locations and contacts
67 sites in 2 countries.
67 sites in 2 countries
United States63 sites
Study site
Albuquerque, New Mexico
Study site
Ann Arbor, Michigan
Study site
Annapolis, Maryland
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Bismarck, North Dakota
Study site
Boston, Massachusetts
Study site
Boulder, Colorado
Study site
Charlotte, North Carolina
Study site
Cherry Hill, New Jersey
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Conway, Arkansas
Study site
Cookeville, Tennessee
Study site
Corvallis, Oregon
Study site
Denver, Colorado
Study site
Durham, North Carolina
Study site
East Syracuse, New York
Study site
Easton, Pennsylvania
Study site
Elmer, New Jersey
Study site
Ft. Pierce, Florida
Study site
Gastonia, North Carolina
Study site
Germantown, Tennessee
Study site
Glendale, California
Study site
Grand Rapids, Michigan
Study site
Hastings, Nebraska
Study site
Houston, Texas
Study site
Johnson City, New York
Study site
Kettering, Ohio
Study site
La Mesa, California
Study site
Lacombe, Louisiana
Study site
Lakeland, Florida
Study site
Lexington, Kentucky
Study site
Mansfield, Ohio
Study site
Maywood, Illinois
Study site
Miami Beach, Florida
Study site
Minneapolis, Minnesota
Study site
Nashville, Tennessee
Study site
New Hyde Park, New York
Study site
Orlando, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Plano, Texas
Study site
Richmond, Virginia
Study site
Rockford, Illinois
Study site
Saint Cloud, Minnesota
Study site
Saint Joseph, Michigan
Study site
Saint Paul, Minnesota
Study site
Salem, Oregon
Study site
Salisbury, Maryland
Study site
Santa Rosa, California
Study site
Scottsdale, Arizona
Study site
Southfield, Michigan
Study site
St Louis, Missouri
Study site
Syracuse, New York
Study site
The Bronx, New York
Study site
Tifton, Georgia
Study site
Toledo, Ohio
Study site
Tupelo, Mississippi
Study site
Tyler, Texas
Study site
Verro Beach, Florida
Study site
Worcester, Massachusetts
Study site
York, Pennsylvania
Canada4 sites
Study site
Sainte-Foy, Quebec
Study site
Trois-Rivières, Quebec
Study site
Vancouver, British Columbia
Study site
Winnipeg, Manitoba
About this study
Official title: Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction (SAVE PACe)
SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outcome of time to development of persistent AF.
Read the detailed description
Conventional dual-chamber pacing maintains atrioventricular synchrony but results in high percentages of ventricular pacing, which causes ventricular desynchronization and has been linked to an increased risk of atrial fibrillation in patients with sinus-node disease.
Patients with sinus-node disease and intact atrioventricular conduction are randomly assigned to receive conventional dual-chamber pacing or dual-chamber minimal ventricular pacing with the use of new Medtronic pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization. The primary end point was time to persistent atrial fibrillation.
- Conditions
- Sick Sinus Syndrome, Heart Failure, Congestive, Atrial Fibrillation, Bradycardia, Ventricular Dysfunction
- Being tested
- Implantable Pulse Generators
- Keywords
- Right Ventricular Pacing, Persistent Atrial Fibrillation, Atrioventricular Conduction, Heart Failure Hospitalization, Cardiovascular Health Care Utilization, Sinus-node Disease, Minimized Ventricular Pacing
- Medical subject headings
- Sick Sinus Syndrome, Heart Failure, Atrial Fibrillation, Bradycardia, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Pulse GeneratorsDevice
Also called Search AV+, Search AV, MVP, Medtronic
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization Receives: Device: Implantable Pulse Generators |
| 2 | No intervention | conventional dual-chamber pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms.
Measured: from Jan 2003 to Dec 2006
Secondary outcomes (1)
To compare composite endpoint of AF and heart failure hospitalization (HFH), HFH, cardiovascular health care utilization, symptoms, HF medications, cumulative %, adverse events and incidence of stroke between the arms.
Measured: from Jan 2003 to Dec 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startJan 2003
- Primary completionDec 2006
- Study completionFeb 2008
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 Sick Sinus SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,070 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael O. Sweeney, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284830
- Sponsor's protocol ID
- 191
- Acronym
- SAVEPACe
- Status last verified
- Feb 2008
- First submitted
- 31 Jan 2006
- Last updated
- 29 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sweeney MO, Bank AJ, Nsah E, Koullick M, Zeng QC, Hettrick D, Sheldon T, Lamas GA; Search AV Extension and Managed Ventricular Pacing for Promoting Atrioventricular Conduction (SAVE PACe) Trial. Minimizing ventricular pacing to reduce atrial fibrillation in sinus-node disease. N Engl J Med. 2007 Sep 6;357(10):1000-8. doi: 10.1056/NEJMoa071880.
PubMed 17804844
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction (SAVE PACe)
- ClinicalTrials.gov ID
- NCT00284830
- Acronym / sponsor ID
- SAVEPACe / 191
- Conditions
- Sick Sinus Syndrome, Heart Failure, Congestive, Atrial Fibrillation, Bradycardia, Ventricular Dysfunction
- Keywords
- Right Ventricular Pacing, Persistent Atrial Fibrillation, Atrioventricular Conduction, Heart Failure Hospitalization, Cardiovascular Health Care Utilization, Sinus-node Disease, Minimized Ventricular Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,070 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 1 Feb 2006 (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.
SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outcome of time to development of persistent AF.
Detailed description
Conventional dual-chamber pacing maintains atrioventricular synchrony but results in high percentages of ventricular pacing, which causes ventricular desynchronization and has been linked to an increased risk of atrial fibrillation in patients with sinus-node disease.
Patients with sinus-node disease and intact atrioventricular conduction are randomly assigned to receive conventional dual-chamber pacing or dual-chamber minimal ventricular pacing with the use of new Medtronic pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization. The primary end point was time to persistent atrial fibrillation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Implantable Pulse Generatorsdual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization |
| 2 | No intervention | –conventional dual-chamber pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age and older
- Willing and able to give informed consent
- Willing and able to comply with the study follow-up schedule
- Class I/ClassII indications for dual chamber pacing
- Initial implant of a Kappa 700, Kappa 900, EnPulse, or EnRhythm dual chamber IPG
Key exclusion criteria (13 listed)
- Less than 18 years of age
- Unwilling or unable to give informed consent
- Unwilling or unable to commit to follow-up schedule
- Medical conditions that would preclude the testing required by the protocol or limit study participation
- Enrolled or intend to participate in another clinical trial during the course of this study
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 |
|---|---|---|
| Implantable Pulse GeneratorsAlso: Search AV+, Search AV, MVP, Medtronicdual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization | Device | 1 |
Primary outcome
To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms.
Time frame: from Jan 2003 to Dec 2006
1 secondary outcome
To compare composite endpoint of AF and heart failure hospitalization (HFH), HFH, cardiovascular health care utilization, symptoms, HF medications, cumulative %, adverse events and incidence of stroke between the arms.
Time frame: from Jan 2003 to Dec 2006
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 29 Feb 2008.
- Results publication: PubMed 17804844Sweeney MO, Bank AJ, Nsah E, Koullick M, Zeng QC, Hettrick D, Sheldon T, Lamas GA; Search AV Extension and Managed Ventricular Pacing for Promoting Atrioventricular Conduction (SAVE PACe) Trial. Minimizing ventricular pacing to reduce atrial fibrillation in sinus-node disease. N Engl J Med. 2007 Sep 6;357(10):1000-8. doi: 10.1056/NEJMoa071880.
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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.
Michael O. Sweeney, MD principal investigator
Brigham and Women's Hospital
67 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Pulse Generators in people with Sick Sinus Syndrome and Heart Failure, Congestive, run by Medtronic Cardiac Rhythm and Heart Failure at 67 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 6 inclusion and 13 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 29 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Canada. 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?
To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms. (time frame: from Jan 2003 to Dec 2006). 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 NCT00284830, 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 29 Feb 2008.