Atrial Fibrillation, Tachycardia, Supraventricular
Conditions
Keywords
Atrial Fibrillation, Supraventricular Tachycardia, Contact Force, RF Ablation, Radiofrequency, Pulmonary Vein Isolation, Paroxysmal Atrial Fibrillation
Brief summary
The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation. In addition, the study will characterize the use and value of contact force measurement during ablation, and the long term success (12 months) of the ablation procedure using this technology.
Detailed description
Safety: The primary safety endpoint assesses the incidence of procedure or device related SAEs from procedure to 7 (±1) days post-procedure or hospital discharge, whichever is longer, for patients with right-sided SVT or 3 months (±2 weeks) post-procedure for patients with atrial fibrillation. Secondary safety objectives were to demonstrate safety (operative and post-operative complications) over the 12 months post-procedure. Performance: The primary performance endpoint is to demonstrate successful catheter deployment, irrigation and ablation at the target area during supra-ventricular cardiac ablation. The secondary performance endpoint is to demonstrate successful and effective contact force reading between catheter tip and heart wall during mapping and ablation at all locations and all angulations. Efficacy: Secondary effectiveness objectives will consider acute and chronic elimination of the target arrhythmia, the cost-effectiveness of the system and procedure-related parameters
Interventions
DEVICEContact force assisted irrigated RF ablation
radiofrequency ablation of atrial fibrillation or SVT
Sponsors
Endosense
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with right-sided SVT (including: atrioventricular nodal re entry tachycardia \[AVNRT\], accessory pathway Wolff Parkinson White \[WPW\] syndrome, atrial tachycardia or isthmus-dependent atrial flutter) or paroxysmal atrial fibrillation
Exclusion criteria
* Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or valve or coronary bypass graft surgery * Moderate or severe structural heart disease (ventricular dysfunction or valve disease) as demonstrated by transthoracic (TTE) or transesophageal echocardiogram (TEE) of all four chambers of the heart * Known cerebrovascular disease, including a history of stroke or transient ischemic attack * Left ventricular ejection fraction of \<35% * Previous heart ablation procedure (surgical or catheter) to the target chamber
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Operative and Post-operative Serious Adverse Events | 3 months for AF arm; 7 days for the right SVT arm | For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer. For AF patients 3 months (±2 weeks)following the index procedure. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atrial Fibrillation Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation. | 34 |
| Right-sided Supraventricular Tachycardia Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT | 43 |
| Total | 77 |
Baseline characteristics
| Characteristic | Total | Atrial Fibrillation | Right-sided Supraventricular Tachycardia |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 57 Participants | 25 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 9 Participants | 11 Participants |
| Sex: Female, Male Female | 25 Participants | 11 Participants | 14 Participants |
| Sex: Female, Male Male | 52 Participants | 23 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 43 |
| serious Total, serious adverse events | 4 / 34 | 1 / 43 |
Outcome results
Primary
Number of Subjects With Operative and Post-operative Serious Adverse Events
For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer. For AF patients 3 months (±2 weeks)following the index procedure.
Time frame: 3 months for AF arm; 7 days for the right SVT arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atrial Fibrillation | Number of Subjects With Operative and Post-operative Serious Adverse Events | 4 participants |
| Right-sided Supraventricular Tachycardia | Number of Subjects With Operative and Post-operative Serious Adverse Events | 1 participants |