Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

Permanent Pacemaker Implantation Clinical Trial

Official title:

Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients (AF-pacemaker Tx Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03401593
• Other study ID #: 4-2017-1028
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2019
• Est. completion date: June 2028

Study information

• Verified date: August 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is prospective randomized study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872). The purpose is to investigate the recurrence rate of AF/AFL/AT in both groups after randomization for 60 months (5 years) in patients post pacemaker implantation and assess long term clinical results.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 135
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872).

• Age: 18-80 years

• Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation

• Estimated percentage of atrial pacing >40% under sinus rhythm (LR=60bpm, close hysteresis and rest rate)

• Estimated percentage of ventricular pacing >40% under sinus rhythm (LR=40bpm, DDD pacing, close hysteresis and rest rate)

• Patients who are willing to sign the informed consent.

• Patients who are willing to receive the implantation and post-operative follow-up.

Exclusion Criteria:

• Persistent or permanent AF

• Severe hepatic and renal insufficiency (AST or ALT = three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min)

• Thyroid gland dysfunction

• Pregnancy

• Malignant tumor

• Severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)

• Life expectancy < 12 months

• Patients unable or unwilling to cooperate in the study procedures.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Permanent Pacemaker Implantation

Intervention

Drug:
• midazolam with fentanyl
Radio-frequency catheter ablation is performed in the post-absorptive state after sedation with midazolam and fentanyl. Multipolar catheters were positioned in the coronary sinus, His, and the right atrium. The three-dimensional LA geometry was reconstructed using a CARTO or NavX electroanatomical mapping system. Circumferential pulmonary vein isolation was performed in all patients using a irrigated-tip catheter. A circular mapping catheter was used to confirm the isolation of the pulmonary veins. Successful ablation was defined by the elimination of all the pulmonary vein potentials along the antrum or inside the veins. If the AF was not terminated after elimination of all the pulmonary vein potentials, linear ablation and complex fragmented atrial electrogram ablation were performed.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of AF/AFL/AT in both groups	recurrence of AF/AFL/AT evaluated using device interrogation	1 year after randomization
Primary	Recurrence rate of AF/AFL/AT in both groups	recurrence of AF/AFL/AT evaluated using device interrogation	6-month follow up to 5 years
Secondary	Left ventricular ejection fraction	cardiac function evaluated using echocardiography	1 year after randomization
Secondary	Left atrial diameter	cardiac function evaluated using echocardiography	1 year after randomization
Secondary	Stroke	ischemic and hemorrhagic stroke	at least 1 year after randomization
Secondary	Stroke	ischemic and hemorrhagic stroke	6-month follow up to 5 years