SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction (SAVEPACe)
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| ClinicalTrials.gov Identifier: NCT00284830 |
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Recruitment Status :
Completed
First Posted : February 1, 2006
Last Update Posted : February 29, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sick Sinus Syndrome Heart Failure, Congestive Atrial Fibrillation Bradycardia Ventricular Dysfunction | Device: Implantable Pulse Generators | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1070 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| Official Title: | Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction (SAVE PACe) |
| Study Start Date : | January 2003 |
| Actual Primary Completion Date : | December 2006 |
| Actual Study Completion Date : | February 2008 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
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Device: Implantable Pulse Generators
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
Other Names:
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No Intervention: 2
conventional dual-chamber pacing
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- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284830
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| Principal Investigator: | Michael O. Sweeney, MD | Brigham and Women's Hospital |
| Responsible Party: | Medtronic CRDM Clinical Research |
| ClinicalTrials.gov Identifier: | NCT00284830 |
| Other Study ID Numbers: |
191 |
| First Posted: | February 1, 2006 Key Record Dates |
| Last Update Posted: | February 29, 2008 |
| Last Verified: | February 2008 |
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Right Ventricular Pacing Persistent Atrial Fibrillation Atrioventricular Conduction Heart Failure Hospitalization |
Cardiovascular Health Care Utilization Sinus-node Disease Minimized Ventricular Pacing |
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Heart Failure Atrial Fibrillation Ventricular Dysfunction Bradycardia Sick Sinus Syndrome Heart Diseases |
Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes Arrhythmia, Sinus Heart Block Cardiac Conduction System Disease |