Trials / Completed
CompletedNCT03845010
Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment
Elimination of Ventricular Premature Beats With CaTheter Ablation Versus OPtImal Anti-arrhythmic Drug Treatment
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Maatschap Cardiologie Zwolle · Academic / Other
- Sex
- All
- Age
- 76 Years
- Healthy volunteers
- Not accepted
Summary
The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of ventricular premature beats (VPB) with catheter ablation versus optimal anti-arrhythmic drugs (AAD) treatment with flecainide/verapamil or sotalol.
Detailed description
The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of VPB with catheter ablation versus optimal AAD treatment with flecainide/verapamil or sotalol. Due to the use of different AAD (with and without beta-blocking abilities) the investigators will be able to explore the secondary objectives. Finally, this study will assess safety of ablation of non-RVOT VPBs and long-term treatment with two different AAD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sotalol | Patients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID) |
| DRUG | Flecainide and verapamil | Patients will receive maximal tolerated dose of flecainide and verapamil with titration to a maximal dose of 200 mg of flecainide and 240 mg of verapamil per day |
| PROCEDURE | Catheter ablation | Patients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine |
Timeline
- Start date
- 2019-02-12
- Primary completion
- 2023-01-17
- Completion
- 2023-01-17
- First posted
- 2019-02-19
- Last updated
- 2023-06-28
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03845010. Inclusion in this directory is not an endorsement.