The study objective is to evaluate the safety and efficacy of the Ablation Frontiers Cardiac Ablation System in the treatment of permanent atrial fibrillation.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Acute
- Use of AFI catheters to achieve procedure success.
- Isolation of all accessible Pulmonary Veins
- Elimination of CFAEs and high frequency intracardiac electrograms mapped and
ablated with AFI catheters
- Termination of AF upon leaving EP lab
Chronic
- Eighty percent reduction of sustained atrial fibrillation when evaluated for
four
consecutive days.
- Off all rhythm control AADs at six months unless concomitant use for other
cardiac
disease.
Secondary outcome
- Improvement of left atrial size compared to baseline.
- Improvement of LV ejection fraction compared to baseline.
- Improved Symptom Severity Score compared to baseline.
- Improvement in the QoL.
Background summary
Atrial fibrillation (AF) remains the most commonly treated sustained arrhythmia
with about five million sufferers worldwide.
The Ablation Frontiers Cardiac Ablation System has been designed to create safe
and effective lesions in the heart providing electrical conduction block to
stop the drivers associated with the propagation of AF.
Study objective
The study objective is to evaluate the safety and efficacy of the Ablation
Frontiers Cardiac Ablation System in the treatment of permanent atrial
fibrillation.
Study design
Prospective, single-arm, multi-center, multi-country, non-randomized trial
Intervention
Treatment of atrial fibrillation using the Ablation Frontiers Cardiac Ablation
System.
Study burden and risks
Neurologic Exam; 5 times during Study duration.
Quality of Life Questionnaire; 6 times during Study duration.
7 Days continuous Monitoring; pre-procedure and during 2, 6 and 12 month
follow-up.
The Ablation Frontiers Cardiac Ablation System is believed to pose little or no
additional risks above other commercialized radiofrequency (RF) ablation
systems.
During the Study non commercialized catheters are used.
5835-118 Avenida Encinas
Carlsbad, CA 92008
USA
5835-118 Avenida Encinas
Carlsbad, CA 92008
USA
Listed location countries
Age
Inclusion criteria
History of symptomatic permanent atrial fibrillation lasting greater than seven days but less than four years with at least one failed DC cardioversion within the previous two years.
Exclusion criteria
Structural heart disease of clinical significance.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12745.100.06 |