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Short Atrioventricular Delay Pacing (SAVD)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01233661
First Posted: November 3, 2010
Last Update Posted: January 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pittsburgh
  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 (Care Provider, 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 ]

Enrollment: 0
Study Start Date: January 2011
Study Completion Date: January 2011
Primary Completion Date: January 2011 (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01233661     History of Changes
Other Study ID Numbers: 08060137
First Submitted: November 2, 2010
First Posted: November 3, 2010
Last Update Posted: January 5, 2016
Last Verified: January 2016