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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01233661
Other study ID # 08060137
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 2011
Est. completion date January 2011

Study information

Verified date January 2016
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • 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

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

Locations

Country Name City State
United States Atrial Arrhythmia Center, UPMC Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum biomarker concentrations 30 days