NCT02243891

AF Ablation With or Without ROX Coupler Study

Left Atrial Ablation for Paroxysmal Atrial Fibrillation and Hypertension With Implantable Loop Recorder With or Without ROX Coupler Follow Up Study: The LAAPITUP 3 Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Neil Sulke · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The study will test the hypothesis that ablation of paroxysmal atrial fibrillation in hypertensive subjects is more effective when a ROX coupler is inserted concurrently.

Detailed description

The single blinded, randomised study is planned to commence in October 2014 after obtaining Research Ethics Committee and NHS Research and Development approval. A target of 20 participants with symptomatic paroxysmal AF will be recruited. All participants will be blinded and randomised to AF ablation only or AF ablation + ROX coupler implant. All participants will have right and left heart catheterisation prior to AF ablation +/- ROX coupler insertion. Participants will be followed up 6 weeks, 3, 6 months and 12 months after the ablation. The study will take place at Eastbourne District General. The study duration per patient is 13months. The overall study duration will be 18 months.

Conditions

• Atrial Fibrillation
• Hypertension

Interventions

Type	Name	Description
PROCEDURE	Atrial fibrillation ablation	Percutaneous catheter ablation for Atrial fibrillation.
PROCEDURE	ROX Coupler insertion	The ROX Coupler is a CE-marked device designed to maintain an iliac arteriovenous fistula

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-12-01
• Completion: 2017-10-01
• First posted: 2014-09-18
• Last updated: 2015-03-10

Locations

1 site across 1 country: United Kingdom