VOLT CE Mark Study

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Documented symptomatic PAF or PersAF. Documentation requirements are as follows:

• Paroxysmal:

⁃ Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND

⁃ One electrocardiographically documented PAF episodes within 12 months prior to enrollment.

• Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by

⁃ Physician's note, AND either

⁃ 24-hour Holter within 180-days prior to enrollment, showing continuous AF, OR

⁃ Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:

∙ That are taken at least 7 days apart but less than 12 months apart

‣ If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment

‣ The most recent electrocardiogram must be within 180 days of enrollment.

• NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.

• Plans to undergo a PVI catheter ablation procedure due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication

• At least 18 years of age

• Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements

• Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.

Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
The Prince Hospital
RECRUITING
Chermside
Monash Health
RECRUITING
Clayton
Royal Melbourne Hospital - City Campus
RECRUITING
Parkville
Austria
A. ö. Krankenhaus der Elisabethinen Linz
RECRUITING
Linz
Belgium
AZ Sint Jan
RECRUITING
Bruges
UZ Brussel
RECRUITING
Brussels
Germany
Universitätsmedizin Berlin - Charité Campus Mitte (CCM)
WITHDRAWN
Berlin
Medizinische Einrichtungen der Universität zu Köln
WITHDRAWN
Cologne
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
RECRUITING
Lübeck
Italy
Az. Osp.Universitaria Osp.Riuniti Umberto I-Lancisi-Salesi
WITHDRAWN
Ancona
Netherlands
UMC Utrecht
RECRUITING
Utrecht
Spain
Hospital Universitari i Politècnic La Fe
RECRUITING
Valencia
Switzerland
Hôpital Cantonal Universitaire de Geneva
WITHDRAWN
Geneva
United Kingdom
St. Bartholomew's Hospital
WITHDRAWN
London
Contact Information
Primary
Jessica Arrett
jessica.arrett@abbott.com
(+1) 612-380-8445
Backup
Amber Miller
amber.miller@abbott.com
(+1) 651-756-2885
Time Frame
Start Date: 2023-10-24
Estimated Completion Date: 2026-12
Participants
Target number of participants: 300
Treatments
Experimental: Volt PFA Catheter Sensor Enabled (SE)
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov