Effectiveness: To provide valid scientific evidence that use of the TactiCath® Set is an effective treatment for symptomatic paroxysmal atrial fibrillation (PAF).Safety: To provide valid scientific evidence that use of the TactiCath® Set is safe as…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effectiveness
The primary effectiveness endpoint of the study is a non-inferiority comparison
of treatment success between the TactiCath® Set and the control device as
defined by both:
• Acute procedural success - electrical isolation of all 4 pulmonary veins
(PVs), or in the event of a common PV, the clinical equivalent of all PVs by
the end of index procedure
• Chronic success - acute procedural success and freedom from recurrence of
symptomatic PAF, atrial flutter (AFL), and atrial tachycardia (AT) lasting
longer than 30 seconds through 9 months of follow-up after a 3 month blanking
period. Re-treatment for AF with ablation or the use of Class I or Class III
antiarrhythmic drugs after the blanking period constitutes a treatment failure.
Safety
The primary safety endpoint is a non-inferiority comparison of device-related
early onset primary SAEs between the TactiCath® Set and the control device
occurring within 7 days of the index procedure or hospital discharge, whichever
is later, and diagnosed at any time during the follow up period.
Secondary outcome
Effectiveness
The secondary effectiveness endpoints are related to the use of the contact
force sensor and will assess procedural effectiveness superiority of the
TactiCath® Set over the control device. It is hypothesized that the use of the
contact force sensor information will result in added procedural effectiveness
through a reduction of:
1. Number of electrically reconnected pulmonary veins following a 30 minute
waiting period assessed by entrance block
2. Time to achieve total PV isolation measured from initial application of RF
energy to all target vessels isolated
3. Total time of RF application required for full PV isolation
Safety
Incidence of all serious adverse events (SAEs) during the 12 month follow up
period
Background summary
Long term outcomes for symptomatic atrial fibrillation (AF) patients treated
exclusively with drugs remains poor.
Circumferential electrical isolation of the entire pulmonary vein (PV)
musculature, also known as PV isolation, is now common practice for patients
with paroxysmal atrial fibrillation (PAF) in whom one or more antiarrhythmic
agents have failed.
Establishing a stable contact force between the catheter and the endocardial
surface remains one of the key challenges in the catheter ablation procedure.
To address this need, Endosense has developed a novel contact force sensor that
is embedded in the TactiCath® catheter that allows measurement of the tip to
tissue contact force during the RF ablation procedure.
The purpose of this study is to evaluate the safety and effectiveness of the
TactiCath® Set when used to treat PAF when compared to an approved control
device.
Study objective
Effectiveness: To provide valid scientific evidence that use of the TactiCath®
Set is an effective treatment for symptomatic paroxysmal atrial fibrillation
(PAF).
Safety: To provide valid scientific evidence that use of the TactiCath® Set is
safe as measured by the incidence of early-onset serious adverse events (SAEs)
when compared to the control device.
Study design
TOCCASTAR is a prospective, randomized, multicenter, interventional study to
evaluate the safety and effectiveness of the TactiCath® Set for the treatment
of symptomatic atrial fibrillation (PAF) using contact force assisted irrigated
RF ablation.
Patients undergoing elective catheter ablation for symptomatic PAF who are
refractory or intolerant to at least one antiarrhythmic drug (Class I-IV) will
be screened for enrollment. Patients who meet the study entry criteria and sign
the patient informed consent form will be enrolled and treated following the
2007 Heart Rhythm Society (HRS)/European Heart Rhythm Association
(EHRA)/European Cardiac Arrhythmia Society (ECAS) Expert Consensus Statement on
Catheter and Surgical Ablation for Atrial Fibrillation.
Eligible patients will be randomly assigned 1:1 to receive treatment with
either the TactiCath® Set or the control device (the NaviStar® ThermoCool® open
irrigated RF ablation catheter manufactured by Biosense Webster, Inc.) Use of
three dimensional (3D) mapping equipment will be required in both treatment
groups. Patients will be blinded to treatment assignment. This study aims to
demonstrate non inferiority of the study device to the control device for both
safety and effectiveness.
After the index procedure, patients will be followed for a total of 12 months
for chronic effectiveness assessment, beginning with a 3-month blanking period
and ending with a 9-month effectiveness assessment period. During the blanking
period, patients may be prescribed a previously ineffective antiarrhythmic drug
and undergo up to 2 repeat ablation procedures (up to 10 days prior to end of
the blanking period) using the same device specified by the initial
randomization. Patients will be evaluated at pre-discharge, at 7 days, at 3, 6
and 12 months post-index procedure and every 6 months thereafter until PMA
approval.
Patients will be enrolled at up to 30 sites in the United States (US) and
elsewhere. A maximum of 50% of patients may be enrolled outside the US.
Intervention
The following evaluations will be done as per the protocol requirements (not
standard of care)
Baseline Evaluations:
Determination of the NYHA functional class
Quality of life assessment
Pregnancy test (women of childbearing potential)
Computed tomography (CT) scan or magnetic resonance imaging (MRI)
Ablation Procedure:
The patients will randomly be treated with one of the following devices:
• TactiCath® Set, or
• Control device (the NaviStar® ThermoCool® open irrigated RF ablation catheter
manufactured by Biosense Webster, Inc.)
Follow up :
7 Day (± 2 days):
Cardiac medications,
Reporting of adverse events
3-Month (± 2 weeks)
Imaging study (CT scan or MRI, consistent with pre treatment method),
NYHA functional class,
TTM: Transtelephonic monitoring (weekly for 4 and 5 months)
6-Month (± 3 weeks)
NYHA functional class,
TTM: Transtelephonic monitoring (Monthly for months 6-12)
12-Month (± 3 weeks):
NYHA functional class,
TTM: Transtelephonic monitoring
Quality of life questionnaire
Every 6 months (± 4 weeks) thereafter until PMA approval (patients will be
contacted via telephone by the investigator )
Adverse events (related to survival and cardiac-related hospitalization)
Arrhythmia history
Study burden and risks
Potential Risks:
TactiCath® Set is CE-marked.
Risks to patients enrolled in this study include all those risks currently
associated with all electrophysiology diagnostic procedures and RF catheter
ablation procedures. The risks of the procedure are related primarily to
mechanical injury to the heart and vessels from catheter manipulation and
thermal injury due to RF current delivery, including the risk of
thromboembolism and myocardial perforation, especially for ablations in the
left atrium.
For those procedures where the physician applies sedation or anesthesia, the
standard risks of anesthesia also exist and include allergic reactions,
pneumonia, aspiration pnuemonitis, atelectesis, prolonged sedation, other
medical complications and in very rare cases, death.
Potential Benefits:
Receiving benefit from participation in the study is not guaranteed.
Anticipated benefits to patients may include, but are not limited to, the
following:
• Patients who receive treatment with the study device may experience shorter
ablation procedure time and improved outcomes, although these objectives may
not be demonstrated in this study
• Patients who participate in the study may receive more frequent and/or
detailed follow up than is normally prescribed as standard of care in any given
practice
• Overall advancement of medical and scientific knowledge may benefit future
patients with similar conditions
Chemin du Grand-Puits 42
Meyrin Geneva 1217
CH
Chemin du Grand-Puits 42
Meyrin Geneva 1217
CH
Listed location countries
Age
Inclusion criteria
1. Patient is planned to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I-IV antiarrhythmic drug
2. Minimum of one episode of PAF greater than 30 seconds in duration within 12 months prior to enrollment documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device
3. Minimum of 3 episodes of PAF within the preceding 12 months documented by patient history
4. Patient is 18 years of age or older
5. Patient is willing and capable of complying unassisted with the study protocol requirements including all specified follow up visits
6. Patient provides written informed consent prior to enrollment in the study
Exclusion criteria
1. Persistent or long-standing persistent atrial fibrillation (AF)
2. Patient has had 4 or more cardioversions in the last 12 months
3. Active systemic infection
4. Presence of implantable cardiac defibrillator (ICD)
5. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months
6. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months
7. Left atrial diameter > 5.0 cm
8. Left ventricular ejection fraction < 35%
9. New York Heart Association (NYHA) class III or IV
10. Previous left atrial ablation procedure, either surgical or catheter ablation
11. Patient has had a left atrial surgical procedure or incision with resulting scar
12. Previous tricuspid or mitral valve replacement or repair
13. Heart disease in which corrective surgery is anticipated within 6 months
14. Bleeding diathesis or suspected pro coagulant state
15. Contraindication to long term antithromboembolic therapy
16. Presence of condition that precludes appropriate vascular access
17. Renal failure requiring dialysis
18. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
19. Contraindication to computed tomography and magnetic resonance angiography
20. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
21. Positive pregnancy test results for female patient of childbearing potential
22. Patient has other anatomic or co morbid conditions that, in the investigator*s opinion, could limit the patient*s ability to participate in the study or to comply with follow up requirements, or impact the scientific soundness of the study results
23. Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this study
24. Patient is unlikely to survive the protocol follow up period of 12 months
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 | NL34761.078.11 |