Gene Therapy for Post-Operative Atrial Fibrillation
Stopped: Problems with receiving investigational agent and problems with funding
United States0Started 2023-10-01
Plain-language summary
This clinical trial will have 2 components: a brief dose-ranging study and a randomized comparison of 2 doses of AdKCNH2-G628S with control cardiac surgery patients. The study will assess safety of the intervention in a population at increased risk for post-operative atrial fibrillation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion:
* Elective valve surgery (alone or with coronary artery bypass grafting surgery) and one of the risk factors listed below, or elective coronary artery bypass grafting surgery with two of the risk factors listed below.
* Risk factors:
* age greater than 70,
* increased left atrial size (\> 4 cm left atrial diameter or LA volume index \> 35 on echocardiogram).
* obesity (body mass index \> 30)
* history of:
* paroxysmal AF
* hypertension
* chronic pulmonary disease
* diabetes mellitus
* clinical heart failure
* rheumatic heart disease
Exclusion:
* persistent or permanent AF
* QTc \> 475 on pre-op ECG or any time in last year (unless due to QT prolonging drug that was stopped \> 5 half-lives before surgery with verification of QT normalization after discontinuing drug)
* QTc prolonging drug use (unless stopped \> 5 half-lives prior to surgery)
* Any antiarrhythmic drug use in last year (inclusive of Vaughan Williams class I and III drugs, not including β-blocker or calcium channel blocker drugs)
* Any history of inherited arrhythmia syndrome
* Any prior or current sustained ventricular arrhythmias
* Any prior or current clinically significant bradyarrhythmias unless already treated with pacemaker and ventricular pacing \<20% (to reliable measure QT interval during the study)
* Any prior gene therapy
* Left ventricular ejection fraction (LVEF) \< 35%
* Prior open chest surgery
* History of or current malignancy, unless documented to…
What they're measuring
1
proportion of patients having a post-operative complication relative to controls