NCT05223725

Gene Therapy for Post-Operative Atrial Fibrillation

AdKCNH2-G628S Gene Therapy for Post-Operative Atrial Fibrillation

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Post-operative AF (POAF) is a specific form of AF occurring in the days after cardiothoracic surgery. A unique element of POAF is the limited duration of risk, which peaks 3 days and dissipates 10 days after surgery. We propose gene therapy for POAF. Our hypothesis is that counteracting AF-related electrical remodeling will disrupt the reentrant electrical circuits integral to maintaining AF. We have extensive preclinical data showing safety and efficacy of adenoviral gene transfer using the gene mutation KNCH2-G628S. When delivered to the atria using adenoviruses and a novel gene painting technique, KCNH2-G628S effectively and specifically prolongs atrial action potential and prevents development of AF for the 10-14-day duration of post-operative AF risk. 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.

Conditions

• Atrial Fibrillation
• Post-operative Atrial Fibrillation

Interventions

Type	Name	Description
BIOLOGICAL	AdKCNH2-G628S	adenovirus containing the transgene KCNH2-G628S

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2022-02-04
• Last updated: 2025-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study