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| Name | Class |
|---|---|
| Endosense | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial Fibrillation | Experimental |
| |
| Right-sided Supraventricular Tachycardia | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contact force assisted irrigated RF ablation | Device | radiofrequency ablation of atrial fibrillation or SVT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months for AF arm; 7 days for the right SVT arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl-Heinz Kuck, Prof | Asklepios Klinik St. Georg, Hamburg, Germany | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22820056 | Result | Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20. | |
| 21872560 |
| Label | URL |
|---|---|
| Reddy VY, et. al, The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study.Heart Rhythm. 2012 Nov;9(11):1789-95 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atrial Fibrillation | Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation. |
| FG001 | Right-sided Supraventricular Tachycardia | Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atrial Fibrillation | Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation. |
| BG001 | Right-sided Supraventricular Tachycardia | Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 3 months for AF arm; 7 days for the right SVT arm |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atrial Fibrillation | Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus Bradycardia | Cardiac disorders | In the SVT arm, the SAE was a sinus bradycardia, followed by pacemaker implantation in a patient treated for atrial flutter with the study device and with a standard ablation catheter for concomitant RA arrhythmias. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hendrik Lambert PhD, VP of Clinical and Regulatory Affairs | St. Jude Medical/Endosense | Hendrik.Lambert@endosense.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013617 | Tachycardia, Supraventricular |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| Result |
| Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jais P, Nakagawa H, Lambert H, Shah DC. A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012 Jan;9(1):18-23. doi: 10.1016/j.hrthm.2011.08.021. Epub 2011 Aug 26. |
| Kuck KH, et.al; A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012 Jan;9(1):18-23 | View source |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 4 |
| 34 |
| 0 |
| 34 |
| EG001 | Right-sided Supraventricular Tachycardia | Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT. | 1 | 43 | 0 | 43 |
|
| Tamponade | Cardiac disorders |
|
| Groin Bleeding | Vascular disorders |
|
| Stroke | Cardiac disorders |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |