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Abbott Atrial Fibrillation Post Approval Study

NCT05434650 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-11-19

No results posted yet for this study

Summary

This post-approval study is designed to provide continued real-world clinical evidence to confirm the safety and long-term effectiveness of atrial fibrillation (AF) radiofrequency (RF) technologies (e.g. TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)) for the treatment of AF.

Conditions

  • Atrial Arrhythmia
  • Atrium; Fibrillation
  • Atrial Tachycardia

Interventions

DEVICE

electrophysiology study and ablation with an Abbott Ablation Catheter

During the cardiac ablation procedure, an ablation catheter (a thin, flexible tube that can be threaded through the blood vessels to the heart) will deliver radiofrequency energy (a type of heat) to one or more areas in the upper left chamber of the heart that is causing the irregular heartbeat. The tip of the catheter will transmit energy to one or more small spots of heart tissue. This energy creates a small scar on the heart. This scar will block the electrical pathway that is causing the rapid heartbeat

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Kristin Ruffner · Abbott

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-21
Primary Completion
2024-10-22
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05434650 on ClinicalTrials.gov