TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Continued Access Protocol

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Continued Access Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088606
• Other study ID #: VP-002 527 Version H
• Status: Completed
• Phase: N/A
• First received: March 12, 2014
• Last updated: January 5, 2016
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: St. Jude Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• symptomatic PAF (Paroxysmal Atrial Fibrillation)refractory to at least one Class I-IV antiarrhythmic drug

• minimum one documented PAF episode >30 sec duration within prior 12 months

• minimum three PAF episodes during prior 12 months

• 18 years or older

Exclusion Criteria:

• persistent or long-standing persistent AF(Atrial Fibrillation)

• four or more cardioversions in prior 12 months

• MI (myocardial infarction), CABG (coronary artery bypass graft) or PCI (percutaneous coronary intervention) within preceding 3 months

• left atrial diameter > 5.0 cm

• LVEF (left ventricular ejection fraction)< 35%

• NYHA (New York Heart Association) class III or IV

• previous left atrial ablation procedure

• previous tricuspid or mitral valve repair surgery

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• TactiCath Quartz treatment
Catheter ablation for the treatment of paroxysmal atrial fibrillation

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrical isolation of all 4 PVs, or in the event of a common PV, the clinical equivalent of all PVs, by the end of index procedure		30 min post ablation	No
Primary	Acute procedural success and freedom from recurrence of symptomatic AF, AFL, and AT lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period. Re-treatment for AF with ablation after 3 months is a failure		12 months post ablation	No
Primary	Device-related early onset primary SAEs occurring within 7 days of the index procedure		7 days post ablation	Yes