Short Atrioventricular Delay Pacing (SAVD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01233661
First received: November 2, 2010
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
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)
Other: short AVD pacing ; prior (stable) programming

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Official Title: Short Atrioventricular Delay Pacing

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • serum biomarker concentrations [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: short AVD pacing
short AVD pacing
Other: short AVD pacing ; prior (stable) programming
short AVD pacing prior (stable) programming
No Intervention: prior (stable) programming
prior (stable) programming
Other: short AVD pacing ; prior (stable) programming
short AVD pacing prior (stable) programming

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01233661

Locations
United States, Pennsylvania
Atrial Arrhythmia Center, UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: David S. Schwartzman, MD Universtity of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01233661     History of Changes
Other Study ID Numbers: 08060137
Study First Received: November 2, 2010
Last Updated: November 21, 2011
Health Authority: USA: IRB

ClinicalTrials.gov processed this record on October 20, 2014