Demonstrate clinical safety and effectiveness of the Ablacath* Mapping Catheter and Ablamap® System in patients with paroxysmal (Redo only) or persistent or long-standing persistent AF. Phenotype patients and demonstrate the prognostication power of…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Safety Endpoint
The primary safety endpoint is defined as freedom from a composite of serious
adverse events (SAEs) occurring within 7 days from the index procedure as
adjudicated by an independent CEC for relatedness to procedure or device.
The primary safety device- or procedure-related SAE composite will be the
combined rate of the following events:
• Atrioesophageal fistula
• Major bleeding complication (BARC 2 or higher)
• Catheter entrapment/entanglement
• Cardiac perforation/tamponade
• Death
• Extended hospitalization (>7 days) related to device or procedure
• Myocardial infarction
• Phrenic nerve paralysis (> 3 months post-procedure)
• Acute pulmonary edema
• Acute or symptomatic pulmonary vein stenosis (>70%)
• Stroke/CVA
• Systemic thromboembolism
• Transient ischemic attack (TIA)
• Vagal nerve injury requiring chronic treatment
• Valvular damage
• Vascular access complication requiring intervention
Primary Effectiveness Endpoint
• Freedom from documented AF episodes lasting > 30 seconds (with or without
AAD) following the index ablation through 12-months.
• Demonstrate predictive value of EGF phenotype for ablation outcome.
Secondary outcome
Secondary Endpoints
Secondary endpoints to characterize the performance of the Ablacath* Mapping
Catheter and Ablamap® System will include:
• Freedom from a composite of SAE occurring within 30 days from post-index
ablation procedure as adjudicated by an independent CEC for relatedness to the
procedure or device.
• Single Procedure: Freedom from documented AF/AFL/AT episodes lasting >30
seconds (with or without AADs) through 12-months following the index ablation
procedure.
• One or More Procedures: Freedom from documented AF/AFL/AT episodes lasting
>30 seconds (with or without AADs) through 12-months after the final ablation
procedure.
• Overall reduction in burden of AF for subset of patients with implanted loop
recorders
• Comparison of 12-month freedom from AF between those with active sources
above threshold and those without active sources above threshold.
• Identification of number and location of identified sources
• Overall procedure time
• Total fluoroscopy time
• Total EGF-guided mapping time
• Total EGG-guided procedure time
Background summary
A prospective, single arm, multi-center, clinical evaluation of the Ablacath*
Mapping Catheter and Ablamap® System utilizing Electrographic Flow (EGF)
mapping to resolve extra-pulmonary vein sources of Atrial Fibrillation and
guide ablation therapy.
Study objective
Demonstrate clinical safety and effectiveness of the Ablacath* Mapping Catheter
and Ablamap® System in patients with paroxysmal (Redo only) or persistent or
long-standing persistent AF.
Phenotype patients and demonstrate the prognostication power of Electrographic
Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following
EGF-guided mapping and ablation.
Study design
The RESOLVE-AF Trial is a prospective, single-arm, multi-center, clinical
investigation of the Ablacath* Mapping Catheter and Ablamap® System utilizing
the Ablamap® Electrographic Flow (EGF) algorithm to identify AF sources to
guide ablation therapy. This study will enroll up to 500 subjects across up to
25 centers in Europe, United States and Canada.
Intervention
Not applicable
Study burden and risks
The possible risks to which you are exposed in this investigation, due to the
Ablacath* Mapping Catheter/System are similar to those risks from a standard of
care catheter mapping and ablation.
3550 Scott Blvd Ste 37B
Santa Clara CA 95054
US
3550 Scott Blvd Ste 37B
Santa Clara CA 95054
US
Listed location countries
Age
Inclusion criteria
1 Suitable candidate for intra-cardiac mapping and ablation of atrial
fibrillation
2 Atrial fibrillation documented by electrocardiographic data (e.g., ECG,
Holter, rhythm strips, loop recorder) within 6 months prior to the index
ablation procedure
3 Above eighteen (18) years of age or of legal age to give informed consent
specific to state and national law
4 Left atrial (LA) diameter <= 6.5 cm or LA volume index <= 50 mL/m2 (use
whichever measure is available or if both available, use the lesser of the two
to qualify)
Exclusion criteria
1. De Novo paroxysmal AF
2. AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or
pericarditis, etc.)
3. Cardiac surgery or intervention within the past 90 days (e.g. percutaneous
coronary intervention, ablation for ventricular arrhythmias, left atrial
appendage occlusion devices, atrial septal defect closure devices,
transcatheter aortic valve replacement)
4. Presence of transvenous pacing or defibrillator leads or an atrial leadless
pacemaker
5. Myocardial infarction within the past 90 days
6. Severe valvular disease or prosthetic valve(s)
7. Contraindication to therapeutic anticoagulation
8. Decompensated heart failure or New York Heart Association (NYHA) Functional
Class IV
9. Positive pregnancy test
10. Any other contraindication to an intracardiac mapping and ablation of
atrial arrhythmias
11. Enrollment in another investigational study evaluating another device,
biologic or drug
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 |
|---|---|
| ClinicalTrials.gov | NCT05883631 |
| CCMO | NL84776.100.23 |