Primary Objective: Evaluate the safety and effectiveness of FIRM-guided procedures in addition to conventional ablation for the treatment of patients with persistent atrial fibrillation (AF).Secondary Objectives:•Evaluate the acute effectiveness of…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Safety endpoints: Freedom from serious adverse events related to the
procedure within 7-10 days of the procedure; and Freedom from cumulative
serious adverse events related to the procedure (including any repeat
procedures required) within one year of the initial procedure .
2.2) Effectiveness endpoints: Single Procedure Freedom from AF/AT recurrence
at 3 months; and Single Procedure Freedom from AF/AT recurrence from 3-12
months after the initial AF ablation procedure
Secondary outcome
1)The acute success of FIRM-guided procedure is defined as elimination of the
source of arrhythmias identified by FIRMap
2) EQ-5D scores pre-procedure will be compared to those post-procedure at all
time points separately and together.
Background summary
According to the American Heart Association, atrial fibrillation affects
approximately 2 million Americans. Atrial fibrillation may reduce cardiac
performance and may result in thrombus formation in the left atrium and
thromboembolic events, such as stroke. Approximately 15% of all strokes occur
in people with atrial fibrillation. Ablation of atrial fibrillation that
specifically targets approximately 2-3 mm outside of the pulmonary vein is
currently a standard of care treatment in subjects with symptomatic atrial
fibrillation who have failed drug therapy. Unfortunately, this procedure is
time consuming, creates substantial damage in the left atrium due to the number
of lesions required, and has mixed success with the best outcomes being 50-70%
freedom from symptoms at 1 year post ablation. Also, as with any invasive
procedure, patient complications may heighten with increased time and
additional radiation exposure.
One of the major issues with the current procedure is the lack of knowledge
about the critical regions of the heart that have the source rhythms causing
and sustaining AF. Some very new technology developed based upon work done
under NIH support at the University of California San Diego has shown promise
in diagnosing these key source rhythms. Ablation to target these sources,
called Focal Impulse and Rotor Modulation (FIRM) guided procedure, shows
promise but need to be evaluated further.
Study objective
Primary Objective:
Evaluate the safety and effectiveness of FIRM-guided procedures in addition to
conventional ablation for the treatment of patients with persistent atrial
fibrillation (AF).
Secondary Objectives:
•Evaluate the acute effectiveness of FIRM-guided procedures in eliminating the
source of arrhythmia.
•Quality of life outcomes.
Study design
This is a prospective, multicenter, randomized study to assess the safety and
effectiveness of FIRM-guided procedures followed by conventional ablation
including PVI versus a standard PVI procedure for the treatment of persistent
atrial fibrillation.
Intervention
Block randomization using a web-based database system will be used to assign
subjects (1:1) to the conventional AF ablation treatment without FIRM-guided
diagnostic procedure, or to the FIRM-guided procedure followed by conventional
AF ablation.
Study burden and risks
The potential risk do not differ from the risks associated with the
conventional/routine ablation procedure described in the Dutch Heart foundation;
- Hematoma Groin
- Thrombus cath, caused Stroke, TIA
- Allergic reaction on medication and material
- damage to a heart valve or the heart muscle
O'Brien Drive Suite B
Menlo Park 94025 CA
US
O'Brien Drive Suite B
Menlo Park 94025 CA
US
Listed location countries
Age
Inclusion criteria
-1.Male or female 18 - 80 years of age.
2.Experiencing at least two (2) documented episodes of persistent atrial fibrillation (including long standing persistent) during the 3 months preceding study entry with clinical indication for AF ablation per guidelines. At least one episode must be documented by rhythm strip or ECG.
3.Refractory, contraindicated, or intolerant to Class I or III anti-arrhythmic medications. Drug doses must be therapeutic and stable.
4.Oral anticoagulation required with either Novel Oral Anticoagulant (e.g. dabigatran, rivaroxaban, apixaban), Warfarin (therapeutic INR >= 2.0 for at least three weeks prior to randomization), or other similar standard-of-care oral anticoagulant therapy is required (aspirin is not considered similar) for those subjects who meet two or more of the following criteria:
a.Age 65 years or older
b.Diabetes
c.Coronary artery disease (CAD)
d.Prior stroke or transient ischemic attack
e.Congestive heart failure
f.Hypertension with systolic>165 mm Hg
5.Willingness and able to remain on anti-coagulation therapy for a minimum of 3 months post procedure for all subjects and at least 12 months post procedure if the patient has CHADS2 score >= 2.
Exclusion criteria
1.Presence of structural heart disease of clinical significance including:Coronary artery disease with either:
oCoronary artery bypass surgery (CABG) within the last six months, or
oStable/unstable angina or ongoing myocardial ischemia
b.Congenital heart disease where either the underlying abnormality or its correction prohibits or increases the risk of ablation.
2.NYHA Class IV.
3.Ejection fraction < 35%.
4.History of myocardial infarction (MI) within the past three months.
5.Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this study.
6.ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve and permanent pacemakers or defribrillator leads
7.Untreatable allergy to contrast media.
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 | NL53840.078.15 |