Short Atrioventricular Delay Pacing (SAVD)

We intend to examine the effects of temporary elevation of atrial wall stress by shortening of the atrioventricular delay in patients with dual-chamber pacemakers.

Study Overview

• Status: Withdrawn
• Conditions: Chronically (i.e. Implanted for at Least Six Months) Dual-chamber Pacemaker; Stable Cardiac Status (i.e. no Hospitalizations or Cardiac Medication Changes Within 3 Months)
• Intervention / Treatment: Other: short AVD pacing ; prior (stable) programming

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Atrial Arrhythmia Center, UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronically (i.e. implanted for at least six months) dual-chamber pacemaker
• Stable cardiac status (i.e. no hospitalizations or cardiac medication changes within 3 months)
• Ability to provide informed consent

Exclusion Criteria:

• Age <18 years or >80 years
• Pregnancy (if pregnancy is suspected, a urine pregnancy test will be performed)
• Recent (within 12 months) left ventricular ejection fraction <50%
• Significant valvular heart disease (mitral regurgitation of greater than mild severity, any degree of mitral stenosis, aortic stenosis or insufficiency of greater than mild severity)
• Prior coronary artery bypass graft or valve surgery, recent (i.e. within 3 months) acute coronary syndrome or percutaneous coronary intervention, or chronic stable angina
• History of clinically important atrial or ventricular tachyarrhythmias, defined as complex ventricular ectopy (i.e. couplets, triplets, or ventricular tachycardia), AF, atrial tachycardia, or other supraventricular tachycardias not cured with prior ablative therapy).
• Significant chronic systemic inflammatory or neoplastic disease
• Chronic renal or hepatic insufficiency. Renal insufficiency will be defined as a creatinine clearance of less than 20 cc/min. Evidence of hepatic insufficiency will consist of abnormal synthetic function (INR >1.4 without oral anticoagulant use, albumin < 3.0 mg/dL) or abnormal clearance function (total bilirubin >2.0).
• Uncorrected thyroid abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: short AVD pacing	Other: short AVD pacing ; prior (stable) programming; short AVD pacing prior (stable) programming
No Intervention: prior (stable) programming

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serum biomarker concentrations	30 days

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: David S. Schwartzman, MD, Universtity of Pittsburgh

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: November 2, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (Estimate): November 3, 2010

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 08060137