Manual vs Amigo SmartTouch Atrial Fibrillation Study (MAST-AF)
|ClinicalTrials.gov Identifier: NCT01583855|
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Procedure: Catheter ablation for atrial fibrillation, manual Device: Ablation using Amigo remote catheter system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Manual vs Amigo SmartTouch Atrial Fibrillation Study|
|Study Start Date :||March 1, 2012|
|Actual Primary Completion Date :||February 28, 2015|
|Actual Study Completion Date :||February 28, 2015|
Active Comparator: Manual ablation
Patients will have their ablation performed manually.
Procedure: Catheter ablation for atrial fibrillation, manual
Ablation for atrial fibrillation will be performed manually
Active Comparator: Ablation using remote catheter system
Ablation for atrial fibrillation using the Amigo remote catheter system
Device: Ablation using Amigo remote catheter system
Atrial fibrillation ablation will be performed using the Amigo remote catheter system
- Contact force delivered [ Time Frame: Contact force information collected at the time of the procedures ]The contact force delivered by the catheter is measured and will be compared between the two groups.
- Quantity and contiguity of ablation lesions [ Time Frame: 3 months post procedure ]Cardiac magnetic resonance will be used to quantify and assess contiguity of ablation lesions.
- Recurrence of atrial fibrillation [ Time Frame: 1 year ]Patients will be asked to attend office follow-up up to one year post procedure to assess for recurrence of atrial fibrillation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583855
|Glenfield Hospital, Groby Road|
|Leicester, United Kingdom, LE3 9QP|
|Principal Investigator:||G Andre Ng, MBChB, PhD||University of Leicester, UK|