Trials / Active Not Recruiting
Active Not RecruitingNCT06676072
A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:
Safety and Effectiveness of the TactiFlex SE Catheter and Volt Pulsed Field Ablation (PFA) Generator in Subjects With Paroxysmal Atrial Fibrillation
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 188 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).
Detailed description
This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory PAF.
Conditions
- Atrial Fibrillation (AF)
- Atrial Arrhythmia
- Paroxysmal AF
- Drug Refractory Paroxysmal Atrial Fibrillation
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PFA Ablation catheter | Deliver RF and/or PF energy using the TactFlex PFA system |
Timeline
- Start date
- 2024-11-22
- Primary completion
- 2026-04-30
- Completion
- 2026-04-30
- First posted
- 2024-11-06
- Last updated
- 2026-01-15
Locations
32 sites across 4 countries: United States, Austria, Lithuania, Netherlands
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06676072. Inclusion in this directory is not an endorsement.