Contact Force Sensing Use in Atrial Fibrillation Ablation
The Role of Contact Force Sensing in Electrical Pulmonary Vein Isolation When Conducting Atrial Fibrillation Ablation
1 other identifier
interventional
40
1 country
1
Brief Summary
There are multiple important factors which need to be monitored when conducting ablation for atrial fibrillation. The contact between the catheter tip and the inside of the heart wall is now measurable and may improve the effectiveness of catheter ablation for atrial fibrillation patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started May 2012
Shorter than P25 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 26, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJune 28, 2012
June 1, 2012
1.6 years
June 26, 2012
June 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Acute Pulmonary Vein Reconnection
1 hour post procedure
Study Arms (2)
Contact Force Known
ACTIVE COMPARATORAblation with contact force data known
Contact Force Not Known
EXPERIMENTALContact Force data unavailable during ablation
Interventions
Eligibility Criteria
You may qualify if:
- Patients with symptomatic AF
You may not qualify if:
- Recent CVA
- Contraindication to warfarin therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Brompton & Harefield Hospital NHS Foundation Trust
London, SW3 6NP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2012
First Posted
June 28, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
June 28, 2012
Record last verified: 2012-06