Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

NCT03401593 | Not Yet Recruiting

• 1 other identifier: 4-2017-1028
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Permanent Pacemaker Implantation

Keywords

ablation; atrial fibrillation; stroke

Outcome Measures

Primary Outcomes (2)

• Recurrence rate of AF/AFL/AT in both groups

  recurrence of AF/AFL/AT evaluated using device interrogation

  1 year after randomization

• 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 Outcomes (4)

• Left ventricular ejection fraction

  1 year after randomization

• Left atrial diameter

  1 year after randomization

• Stroke

  at least 1 year after randomization

• Stroke

  6-month follow up to 5 years

Study Arms (2)

ablation

ACTIVE COMPARATOR

Patients in this group are treated with radio-frequency catheter ablation.

Drug: midazolam with fentanyl

non-ablation

NO INTERVENTION

Patients in this group are treated with rate control medications (e.g., beta blocker, calcium channel blocker, and digitalis) and anti-arrhythmic drugs. They also can be treated with DC cardio-version.

Interventions

midazolam with fentanyl DRUG

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.

ablation

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Midazolam; Fentanyl

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 17, 2018
• Study Start: October 1, 2019
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 29, 2019

Record last verified: 2019-08

Locations

KR (1)