SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction

Atrial Fibrillation Clinical Trial

— SAVEPACe  

Official title:

Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction (SAVE PACe)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284830
• Other study ID #: 191
• Status: Completed
• Phase: N/A
• First received: January 31, 2006
• Last updated: February 26, 2008
• Start date: January 2003
• Est. completion date: February 2008

Study information

• Verified date: February 2008
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1070
• Est. completion date: February 2008
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bradycardia
• Heart Failure
• Heart Failure, Congestive
• Sick Sinus Syndrome
• Ventricular Dysfunction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No