Trials / Recruiting
RecruitingNCT03546374
Medtronic Terminate AF Study
Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- Medtronic Cardiac Surgery · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).
Detailed description
This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the United States (US). The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months. The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Surgical Ablation | In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed. |
| DEVICE | Cardioblate and Cryoflex hand held devices | The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices. |
Timeline
- Start date
- 2018-11-15
- Primary completion
- 2024-10-01
- Completion
- 2026-12-01
- First posted
- 2018-06-06
- Last updated
- 2026-03-05
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03546374. Inclusion in this directory is not an endorsement.