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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 2 | No Intervention | conventional dual-chamber pacing |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Pulse Generators | Device | dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms. | from Jan 2003 to Dec 2006 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from Jan 2003 to Dec 2006 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael O. Sweeney, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17804844 | Result | 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. |
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| Scottsdale |
| Arizona |
| United States |
| Conway | Arkansas | United States |
| Glendale | California | United States |
| La Mesa | California | United States |
| Santa Rosa | California | United States |
| Boulder | Colorado | United States |
| Denver | Colorado | United States |
| Clearwater | Florida | United States |
| Ft. Pierce | Florida | United States |
| Lakeland | Florida | United States |
| Miami Beach | Florida | United States |
| Orlando | Florida | United States |
| Verro Beach | Florida | United States |
| Atlanta | Georgia | United States |
| Tifton | Georgia | United States |
| Maywood | Illinois | United States |
| Rockford | Illinois | United States |
| Lexington | Kentucky | United States |
| Lacombe | Louisiana | United States |
| Annapolis | Maryland | United States |
| Salisbury | Maryland | United States |
| Boston | Massachusetts | United States |
| Worcester | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Grand Rapids | Michigan | United States |
| Saint Joseph | Michigan | United States |
| Southfield | Michigan | United States |
| Minneapolis | Minnesota | United States |
| Saint Cloud | Minnesota | United States |
| Saint Paul | Minnesota | United States |
| Tupelo | Mississippi | United States |
| St Louis | Missouri | United States |
| Hastings | Nebraska | United States |
| Cherry Hill | New Jersey | United States |
| Elmer | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| East Syracuse | New York | United States |
| Johnson City | New York | United States |
| New Hyde Park | New York | United States |
| Syracuse | New York | United States |
| The Bronx | New York | United States |
| Charlotte | North Carolina | United States |
| Durham | North Carolina | United States |
| Gastonia | North Carolina | United States |
| Bismarck | North Dakota | United States |
| Cincinnati | Ohio | United States |
| Kettering | Ohio | United States |
| Mansfield | Ohio | United States |
| Toledo | Ohio | United States |
| Corvallis | Oregon | United States |
| Salem | Oregon | United States |
| Easton | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| York | Pennsylvania | United States |
| Cookeville | Tennessee | United States |
| Germantown | Tennessee | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Houston | Texas | United States |
| Plano | Texas | United States |
| Tyler | Texas | United States |
| Richmond | Virginia | United States |
| Vancouver | British Columbia | Canada |
| Winnipeg | Manitoba | Canada |
| Sainte-Foy | Quebec | Canada |
| Trois-Rivières | Quebec | Canada |
| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| D001919 | Bradycardia |
| D018754 | Ventricular Dysfunction |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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